ITTO20130375A1 - PRODUCT FOR USE FOR THERAPEUTIC TREATMENT OF PARODONTOPATHIES AND PERIMPLANTS - Google Patents
PRODUCT FOR USE FOR THERAPEUTIC TREATMENT OF PARODONTOPATHIES AND PERIMPLANTSInfo
- Publication number
- ITTO20130375A1 ITTO20130375A1 IT000375A ITTO20130375A ITTO20130375A1 IT TO20130375 A1 ITTO20130375 A1 IT TO20130375A1 IT 000375 A IT000375 A IT 000375A IT TO20130375 A ITTO20130375 A IT TO20130375A IT TO20130375 A1 ITTO20130375 A1 IT TO20130375A1
- Authority
- IT
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- Prior art keywords
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- product according
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- periodontal
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- Prior art date
Links
- 238000011282 treatment Methods 0.000 title claims description 17
- 230000001225 therapeutic effect Effects 0.000 title claims description 9
- 239000000203 mixture Substances 0.000 claims description 15
- 208000005888 Periodontal Pocket Diseases 0.000 claims description 13
- 150000003839 salts Chemical class 0.000 claims description 11
- 208000028169 periodontal disease Diseases 0.000 claims description 10
- 208000006389 Peri-Implantitis Diseases 0.000 claims description 9
- 230000003115 biocidal effect Effects 0.000 claims description 9
- 239000007864 aqueous solution Substances 0.000 claims description 8
- 239000004568 cement Substances 0.000 claims description 8
- 238000004132 cross linking Methods 0.000 claims description 8
- 229960000282 metronidazole Drugs 0.000 claims description 8
- VAOCPAMSLUNLGC-UHFFFAOYSA-N metronidazole Chemical compound CC1=NC=C([N+]([O-])=O)N1CCO VAOCPAMSLUNLGC-UHFFFAOYSA-N 0.000 claims description 8
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 7
- 239000007943 implant Substances 0.000 claims description 7
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 7
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical group CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims description 6
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims description 6
- 229940072056 alginate Drugs 0.000 claims description 6
- 235000010443 alginic acid Nutrition 0.000 claims description 6
- 229920000615 alginic acid Polymers 0.000 claims description 6
- 235000010413 sodium alginate Nutrition 0.000 claims description 6
- 239000000661 sodium alginate Substances 0.000 claims description 6
- 229940005550 sodium alginate Drugs 0.000 claims description 6
- 229920000249 biocompatible polymer Polymers 0.000 claims description 5
- 150000001768 cations Chemical class 0.000 claims description 5
- 229960002476 metronidazole benzoate Drugs 0.000 claims description 5
- CUUCCLJJOWSASK-UHFFFAOYSA-N metronidazole benzoate Chemical compound CC1=NC=C([N+]([O-])=O)N1CCOC(=O)C1=CC=CC=C1 CUUCCLJJOWSASK-UHFFFAOYSA-N 0.000 claims description 5
- 238000002360 preparation method Methods 0.000 claims description 5
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims description 4
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical class OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 4
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical class OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims description 4
- 239000001110 calcium chloride Substances 0.000 claims description 4
- 229910001628 calcium chloride Inorganic materials 0.000 claims description 4
- 230000005855 radiation Effects 0.000 claims description 4
- JIAARYAFYJHUJI-UHFFFAOYSA-L zinc dichloride Chemical compound [Cl-].[Cl-].[Zn+2] JIAARYAFYJHUJI-UHFFFAOYSA-L 0.000 claims description 4
- 239000004098 Tetracycline Substances 0.000 claims description 3
- 239000003242 anti bacterial agent Substances 0.000 claims description 3
- 229920002988 biodegradable polymer Polymers 0.000 claims description 3
- 239000004621 biodegradable polymer Substances 0.000 claims description 3
- 238000010952 in-situ formation Methods 0.000 claims description 3
- 229960002292 piperacillin Drugs 0.000 claims description 3
- WCMIIGXFCMNQDS-IDYPWDAWSA-M piperacillin sodium Chemical compound [Na+].O=C1C(=O)N(CC)CCN1C(=O)N[C@H](C=1C=CC=CC=1)C(=O)N[C@@H]1C(=O)N2[C@@H](C([O-])=O)C(C)(C)S[C@@H]21 WCMIIGXFCMNQDS-IDYPWDAWSA-M 0.000 claims description 3
- 229960002180 tetracycline Drugs 0.000 claims description 3
- 229930101283 tetracycline Natural products 0.000 claims description 3
- 235000019364 tetracycline Nutrition 0.000 claims description 3
- 150000003522 tetracyclines Chemical class 0.000 claims description 3
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 2
- 239000011575 calcium Substances 0.000 claims description 2
- 229910052791 calcium Inorganic materials 0.000 claims description 2
- 238000010382 chemical cross-linking Methods 0.000 claims description 2
- 239000003431 cross linking reagent Substances 0.000 claims description 2
- 239000003814 drug Substances 0.000 claims description 2
- 150000004673 fluoride salts Chemical class 0.000 claims description 2
- 150000004694 iodide salts Chemical class 0.000 claims description 2
- 239000011777 magnesium Substances 0.000 claims description 2
- 229910001629 magnesium chloride Inorganic materials 0.000 claims description 2
- 239000011592 zinc chloride Substances 0.000 claims description 2
- 235000005074 zinc chloride Nutrition 0.000 claims description 2
- 150000003841 chloride salts Chemical class 0.000 claims 1
- 230000001580 bacterial effect Effects 0.000 description 4
- 230000003239 periodontal effect Effects 0.000 description 4
- 239000004053 dental implant Substances 0.000 description 3
- 208000015181 infectious disease Diseases 0.000 description 3
- 230000007170 pathology Effects 0.000 description 3
- 239000004971 Cross linker Substances 0.000 description 2
- 210000000988 bone and bone Anatomy 0.000 description 2
- 238000012512 characterization method Methods 0.000 description 2
- 229960003333 chlorhexidine gluconate Drugs 0.000 description 2
- YZIYKJHYYHPJIB-UUPCJSQJSA-N chlorhexidine gluconate Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O.C1=CC(Cl)=CC=C1NC(=N)NC(=N)NCCCCCCNC(=N)NC(=N)NC1=CC=C(Cl)C=C1 YZIYKJHYYHPJIB-UUPCJSQJSA-N 0.000 description 2
- 230000008030 elimination Effects 0.000 description 2
- 238000003379 elimination reaction Methods 0.000 description 2
- 239000010794 food waste Substances 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 241000167880 Hirundinidae Species 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000003385 bacteriostatic effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 150000001805 chlorine compounds Chemical class 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000012456 homogeneous solution Substances 0.000 description 1
- 238000011065 in-situ storage Methods 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 239000003589 local anesthetic agent Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 210000000214 mouth Anatomy 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 230000001131 transforming effect Effects 0.000 description 1
- 241001148471 unidentified anaerobic bacterium Species 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0052—Mixtures of macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/001—Use of materials characterised by their function or physical properties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/001—Use of materials characterised by their function or physical properties
- A61L24/0015—Medicaments; Biocides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
- A61L24/043—Mixtures of macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
- A61L26/0066—Medicaments; Biocides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
- A61L2300/406—Antibiotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/06—Flowable or injectable implant compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/12—Materials or treatment for tissue regeneration for dental implants or prostheses
Landscapes
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Materials Engineering (AREA)
- Surgery (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
“Prodotto per l’uso per il trattamento terapeutico di parodontopatie e perimplantiti†⠀ œProduct for use for the therapeutic treatment of periodontal disease and peri-implantitisâ €
DESCRIZIONE DESCRIPTION
La presente invenzione rientra nel campo della parodontologia e implantologia. The present invention falls within the field of periodontology and implantology.
Più in particolare, la presente invenzione rientra nel campo dei trattamenti terapeutici delle parodontopatie e/o perimplantiti. More particularly, the present invention falls within the field of therapeutic treatments for periodontal diseases and / or peri-implantitis.
Le parodontopatie e le perimplantiti sono patologie accomunate dalla presenza degli stessi microrganismi nelle lesioni, o tasche, parodontali del paziente e sono altresì accomunate dal fatto che, nel corso della patologia, si sviluppa un danno che consiste nella perdita di tessuto osseo di supporto. Periodontal diseases and peri-implantitis are pathologies united by the presence of the same microorganisms in the patient's periodontal lesions, or pockets, and are also united by the fact that, during the course of the disease, damage develops which consists in the loss of supporting bone tissue.
Il brevetto statunitense US 6.017.516 descrive il trattamento di patologie parodontali mediante l’applicazione topica di metronidazolo benzoato e clorexidina gluconato sotto forma di gel acquoso. Preparazioni farmaceutiche parodontali comprendenti metronidazolo benzoato, clorexidina gluconato ed un anestetico locale sono altresì descritte nel brevetto statunitense US 6.365.131. US patent US 6,017,516 describes the treatment of periodontal pathologies by topical application of metronidazole benzoate and chlorhexidine gluconate in the form of aqueous gel. Periodontal pharmaceutical preparations comprising metronidazole benzoate, chlorhexidine gluconate and a local anesthetic are also described in US patent US 6,365,131.
Le preparazioni della tecnica nota presentano tuttavia lo svantaggio di possedere una consistenza eccessivamente fluida, con la conseguenza che, dopo poche ore dall’applicazione nel cavo orale del paziente, la loro efficacia svanisce completamente in quanto lo stesso paziente inevitabilmente le deglutisce. However, the preparations of the known art have the disadvantage of having an excessively fluid consistency, with the consequence that, after a few hours from their application in the patient's oral cavity, their effectiveness disappears completely as the patient himself inevitably swallows them.
Onde superare questi ed altri inconvenienti della tecnica nota, i presenti inventori hanno messo a disposizione un prodotto combinato per l’impiego in parodontologia e/o implantologia, caratterizzato dal fatto di comprendere un primo componente consistente in una miscela di un polimero biocompatibile, un alginato e un antibiotico per parodontologia in soluzione acquosa e, fisicamente separato da detto primo componente, un secondo componente consistente in una soluzione acquosa di un sale di un catione bivalente, trivalente o multivalente. In order to overcome these and other drawbacks of the prior art, the present inventors have made available a combined product for use in periodontology and / or implantology, characterized in that it comprises a first component consisting of a mixture of a biocompatible polymer, a alginate is an antibiotic for periodontology in aqueous solution and, physically separated from said first component, a second component consisting of an aqueous solution of a salt of a divalent, trivalent or multivalent cation.
In una forma di realizzazione preferita della presente invenzione, il polimero biocompatibile à ̈ alcool polivinilico. Più preferibilmente, l’alcool polivinilico ha un peso molecolare compreso nell’intervallo di 100 a 1.000.000, ed à ̈ presente nel primo componente ad una concentrazione compresa nell’intervallo di 1-30% p/p. In a preferred embodiment of the present invention, the biocompatible polymer is polyvinyl alcohol. More preferably, polyvinyl alcohol has a molecular weight in the range of 100 to 1,000,000, and is present in the first component at a concentration in the range of 1-30% w / w.
In un’altra forma di realizzazione preferita della presente invenzione, l’alginato à ̈ alginato di sodio ed à ̈ presente nel primo componente ad una concentrazione nell’intervallo di 0,1 a 10% p/p. E’ maggiormente preferito l’impiego di alginato di sodio con viscosità variabile fra 50 e 2000 cp a 20 °C riferita ad una soluzione al 2%. In another preferred embodiment of the present invention, the alginate is sodium alginate and is present in the first component at a concentration in the range of 0.1 to 10% w / w. The use of sodium alginate with viscosity varying between 50 and 2000 cp at 20 ° C referred to a 2% solution is more preferred.
In una ulteriore forma di realizzazione preferita della presente invenzione, l’antibiotico per parodontologia o implantologia à ̈ scelto dal gruppo che consiste di metronidazolo, metronidazolo benzoato, tetraciclina, piperacillina e qualsiasi loro combinazione. La concentrazione dell’antibiotico nel primo componente à ̈ preferibilmente compresa nell’intervallo di 1-70% in peso, più preferibilmente 20-40% in peso. In a further preferred embodiment of the present invention, the antibiotic for periodontology or implantology is selected from the group consisting of metronidazole, metronidazole benzoate, tetracycline, piperacillin and any combination thereof. The concentration of the antibiotic in the first component is preferably included in the range of 1-70% by weight, more preferably 20-40% by weight.
In ancora un’altra forma di realizzazione preferita della presente invenzione, il catione à ̈ scelto dal gruppo che consiste di Ca<2+>, Mg<2+>e Fe<2+>. In yet another preferred embodiment of the present invention, the cation is selected from the group consisting of Ca <2+>, Mg <2+> and Fe <2+>.
Preferibilmente, il sale à ̈ scelto dal gruppo che consiste di cloruri, ioduri, fluoruri, sali dell’acido fosforico e sali dell’acido solforico. Ancora più preferibilmente, il sale à ̈ scelto dal gruppo che consiste di cloruro di calcio, cloruro di magnesio e cloruro di zinco. Preferably, the salt is selected from the group consisting of chlorides, iodides, fluorides, salts of phosphoric acid and salts of sulfuric acid. Even more preferably, the salt is selected from the group consisting of calcium chloride, magnesium chloride and zinc chloride.
Secondo una forma di realizzazione particolarmente preferita della presente invenzione, il primo componente à ̈ una miscela in soluzione acquosa di alcool polivinilico con peso molecolare di circa 100.000 alla concentrazione di circa il 10% in peso, alginato di sodio alla concentrazione di circa l’1% in peso e metronidazolo alla concentrazione di circa il 25% in peso. According to a particularly preferred embodiment of the present invention, the first component is a mixture in aqueous solution of polyvinyl alcohol with a molecular weight of about 100,000 at a concentration of about 10% by weight, sodium alginate at a concentration of about 1 1% by weight and metronidazole at a concentration of about 25% by weight.
Il primo componente, che preferibilmente si presenta sotto forma di gel acquoso, viene depositato nella tasca parodontale del paziente affetto da patologia parodontale, in modo tale da riempirla e adattarsi alla sua forma. In alternativa, esso viene depositato in prossimità di un impianto in un paziente affetto da perimplantite. Successivamente, quando il primo componente si à ̈ posizionato nel modo corretto (ossia generalmente dopo pochi minuti) esso viene irrorato con il secondo componente, che funge da agente reticolante, ottenendo per mezzo di ciò la reticolazione del primo componente e la formazione in situ di un cemento gommoso. The first component, which preferably takes the form of an aqueous gel, is deposited in the periodontal pocket of the patient suffering from periodontal disease, in such a way as to fill it and adapt to its shape. Alternatively, it is placed near an implant in a patient suffering from peri-implantitis. Subsequently, when the first component is positioned in the correct way (i.e. generally after a few minutes) it is sprayed with the second component, which acts as a cross-linking agent, obtaining by means of this the cross-linking of the first component and the formation in situ of a rubbery concrete.
In alternativa alla reticolazione mediante trattamento chimico con una soluzione salina come sopra descritto, i presenti inventori preconizzano l’efficacia di un trattamento di reticolazione di tipo fisico del primo componente, ad esempio mediante radiazione UV. In tal caso à ̈ preferito che il polimero biodegradabile utilizzato nel primo componente sia fotosensibile. As an alternative to crosslinking by chemical treatment with a saline solution as described above, the present inventors advocate the effectiveness of a physical crosslinking treatment of the first component, for example by means of UV radiation. In this case it is preferred that the biodegradable polymer used in the first component is photosensitive.
Pertanto, rientra altresì nell’ambito della presente invenzione l’uso di una composizione per parodontologia e/o implantologia, avente le caratteristiche del primo componente sopra illustrato, per la preparazione di un medicamento per il trattamento terapeutico di una parodontopatia o una perimplantite, in cui detto trattamento terapeutico comprende applicare detta composizione alla tasca parodontale o alle tasche parodontali di un paziente affetto da parodontopatia oppure applicare detta composizione alla zona circostante un impianto in un paziente affetto da perimplantite e successivamente sottoporre detta composizione ad un trattamento di reticolazione, preferibilmente mediante radiazione UV, ottenendo per mezzo di ciò la formazione in situ di un cemento gommoso. Therefore, the use of a composition for periodontology and / or implantology, having the characteristics of the first component illustrated above, for the preparation of a medicament for the therapeutic treatment of a periodontal disease or a peri-implantitis, wherein said therapeutic treatment comprises applying said composition to the periodontal pocket or periodontal pockets of a patient suffering from periodontal disease or applying said composition to the area surrounding an implant in a patient suffering from peri-implantitis and subsequently subjecting said composition to a cross-linking treatment, preferably by UV radiation, thereby obtaining the in situ formation of a rubbery cement.
Il cemento gommoso, indipendentemente dal fatto di essere ottenuto mediante reticolazione chimica o mediante radiazione UV, à ̈ vantaggiosamente in grado di esplicare una triplice azione. In primo luogo, esso effettua un’azione abrasiva del film batterico presente nel sito di applicazione (ossia la tasca parodontale o la zona circostante l’impianto), al fine di ottenere una sua riduzione od eliminazione. In secondo luogo, esso esplica un’azione riempitiva, all’interno della zona di applicazione, al fine di ostacolare l’infiltrazione dei residui alimentari che spesso sono all’origine dell’infezione. A tutto ciò si aggiunge l’azione battericida e/o batteriostatica dell’antibiotico, che viene rilasciato nel corso del tempo dal cemento gommoso, andando a sopprimere la carica microbica (principalmente batteri anaerobi) contenuta nei detriti distaccati del film batterico. The rubbery cement, regardless of whether it is obtained by chemical crosslinking or by UV radiation, is advantageously capable of performing a triple action. First of all, it carries out an abrasive action on the bacterial film present in the application site (ie the periodontal pocket or the area surrounding the implant), in order to obtain its reduction or elimination. Secondly, it performs a filling action, inside the application area, in order to hinder the infiltration of food residues that are often at the origin of the infection. To all this is added the bactericidal and / or bacteriostatic action of the antibiotic, which is released over time by the rubbery cement, suppressing the microbial load (mainly anaerobic bacteria) contained in the detached debris of the bacterial film.
Gli esempi che seguono, che riguardano la preparazione, la caratterizzazione e l’impiego del prodotto farmaceutico dell’invenzione, sono forniti a scopo meramente illustrativo e non sono intesi a limitare in alcun modo la portata della presente invenzione come definita dalle annesse rivendicazioni. The following examples, which concern the preparation, characterization and use of the pharmaceutical product of the invention, are provided for illustrative purposes only and are not intended to limit in any way the scope of the present invention as defined by the attached claims .
ESEMPIO 1: Preparazione EXAMPLE 1: Preparation
Il gel di base (primo componente) à ̈ stato ottenuto disciogliendo in acqua alcool polivinilico, di peso molecolare pari a 100.000, ad una concentrazione del 10% in peso. La soluzione à ̈ stata agitata fino all’ottenimento di una soluzione omogenea, dopodiché à ̈ stato aggiunto alginato di sodio, con viscosità specifica di 4.000 cp, in concentrazione dell’1% in peso. Al tutto à ̈ stato infine aggiunto metronidazolo ad una concentrazione del 25% in peso. The base gel (first component) was obtained by dissolving polyvinyl alcohol with a molecular weight of 100,000 in water at a concentration of 10% by weight. The solution was stirred until a homogeneous solution was obtained, after which sodium alginate was added, with a specific viscosity of 4,000 cp, in a concentration of 1% by weight. Finally metronidazole was added to the whole at a concentration of 25% by weight.
Il reticolante (secondo componente) atto a trasformare il gel in un solido avente la consistenza di una morbida gomma, era una soluzione acquosa di cloruro di calcio 1 molare. The crosslinker (second component) capable of transforming the gel into a solid having the consistency of a soft rubber, was a 1 molar aqueous solution of calcium chloride.
ESEMPIO 2: Applicazione EXAMPLE 2: Application
Il gel contenente metronidazolo preparato secondo l’esempio 1 à ̈ stato introdotto nelle tasche parodontali (o applicato intorno ad impianti dentali) per mezzo di una siringa con ago smusso e poi solidificato mediante l’applicazione del reticolante a base di cloruro di calcio preparato secondo l’esempio 1, per mezzo di una seconda siringa. The gel containing metronidazole prepared according to example 1 was introduced into the periodontal pockets (or applied around dental implants) by means of a syringe with a blunt needle and then solidified by applying the crosslinker based on calcium chloride prepared according to example 1, by means of a second syringe.
Una volta formatosi in loco, il cemento parodontale sigilla la tasca parodontale (o la zona intorno all’impianto dentale) impedendo ai residui di cibo di penetrare nella tasca o nelle vicinanze dell’impianto. In seguito, grazie alla sua solidità (vedi esempio 3), esso effettua altresì un’azione meccanica contro il film batterico presente nella tasca dentale favorendone l’abbattimento. Inoltre, grazie al rilascio di piccole dosi locali di antibiotico, esso favorisce la ripresa della flora batterica sana nella tasca parodontale (o concorre alla diminuzione del rischio d’infezione e rigetto della protesi dentale). Once formed on site, the periodontal cement seals the periodontal pocket (or the area around the dental implant) preventing food residues from entering the pocket or near the implant. Subsequently, thanks to its solidity (see example 3), it also carries out a mechanical action against the bacterial film present in the dental pocket, favoring its elimination. Moreover, thanks to the release of small local doses of antibiotic, it favors the recovery of healthy bacterial flora in the periodontal pocket (or contributes to the reduction of the risk of infection and rejection of the dental prosthesis).
ESEMPIO 3: Caratterizzazione del cemento EXAMPLE 3: Characterization of the cement
Il cemento gommoso ottenuto con la procedura descritta nell’esempio 2 à ̈ caratterizzato da elasticità e capacità di rilascio del metronidazolo contenuto al suo interno. Sono state effettuate misurazioni del modulo elastico in campioni specifici, dalle quali à ̈ risultato che esso à ̈ compreso tra 10<5>e 10<6>Dyne per centimetro quadro. Il rilascio del metronidazolo à ̈ risultato dell’ordine di 2 mg al giorno in campioni del volume di 0,3 millilitri per una durata superiore a 15 giorni. The rubbery cement obtained with the procedure described in example 2 is characterized by the elasticity and ability to release the metronidazole contained within it. Elastic modulus measurements were made in specific samples, which showed that it is between 10 <5> and 10 <6> Dyne per square centimeter. The release of metronidazole resulted in the order of 2 mg per day in samples with a volume of 0.3 milliliters for a duration of more than 15 days.
ESEMPIO 4: Studi clinici preliminari EXAMPLE 4: Preliminary clinical studies
Studi clinici preliminari, effettuati con il prodotto dell’esempio 1, hanno dimostrato un’efficacia pari al 100% in tasche paradontali medie (fino a 6 mm) entro 15 giorni dalla singola ed unica applicazione iniziale. Per tasche di maggiore profondità (1 cm circa) à ̈ stato documentato un effetto positivo, ma la risoluzione della patologia avviene in tempi più lunghi (in fase di osservazione). L’applicazione su impianti dentali ha ugualmente portato alla risoluzione dell’infezione ed ad un miglioramento del tessuto osseo intorno all’impianto trattato. Preliminary clinical studies, carried out with the product of example 1, have shown an efficacy equal to 100% in medium periodontal pockets (up to 6 mm) within 15 days of the single and only initial application. For pockets of greater depth (about 1 cm) a positive effect has been documented, but the resolution of the pathology occurs in a longer time (during the observation phase). The application on dental implants also led to the resolution of the infection and to an improvement of the bone tissue around the treated implant.
Va altresì sottolineato che la consistenza gommosa del cemento fa sì che esso rimanga imprigionato nella tasca paradontale, ma anche nel caso in cui piccoli pezzi vengano ingeriti, data la sua morbidezza, esso à ̈ assolutamente innocuo per il paziente. It should also be emphasized that the rubbery consistency of the cement means that it remains imprisoned in the periodontal pocket, but even if small pieces are ingested, given its softness, it is absolutely harmless for the patient.
Claims (18)
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| IT000375A ITTO20130375A1 (en) | 2013-05-10 | 2013-05-10 | PRODUCT FOR USE FOR THERAPEUTIC TREATMENT OF PARODONTOPATHIES AND PERIMPLANTS |
| PCT/IB2014/061321 WO2014181299A1 (en) | 2013-05-10 | 2014-05-09 | A product for use in the therapeutic treatment of periodontitis and peri- implantitis |
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| US20220211902A1 (en) * | 2019-04-03 | 2022-07-07 | Dtech - Società A Responsabilità Limitata | Two-component system for the therapeutic treatment of skin lesions and production method thereof |
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| RU2286764C1 (en) * | 2005-06-16 | 2006-11-10 | Георгий Георгиевич Ростиашвили | Agent of prolonged action for treatment of mouth cavity inflammation diseases |
| US20090148486A1 (en) * | 2005-04-28 | 2009-06-11 | Helen Lu | Compositions and methods for treating pulp inflammations caused by infection or trauma |
| US20100080791A1 (en) * | 2008-09-26 | 2010-04-01 | Rousseau Robert A | Composition and Method For Treating Tissue Defects |
| WO2010117266A1 (en) * | 2009-04-06 | 2010-10-14 | Broockeville Corporation N.V. | In situ gelling alginate systems |
| WO2013071235A1 (en) * | 2011-11-13 | 2013-05-16 | Suneris Inc. | In-situ cross-linkable polymeric compositions and methods thereof |
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| US6365131B1 (en) | 1997-10-31 | 2002-04-02 | J. B. Chemicals & Pharmaceuticals Ltd. | Pharmaceutical dental formulation for topical application of metronidazole benzoate, chlorhexidine gluconate and local anesthetic |
| US6017516A (en) | 1997-10-31 | 2000-01-25 | Lekar Pharma Limited | Pharmaceutical dental formulation for topical application of metronidazole benzoate and chlorhexidine gluconate |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US20090148486A1 (en) * | 2005-04-28 | 2009-06-11 | Helen Lu | Compositions and methods for treating pulp inflammations caused by infection or trauma |
| RU2286764C1 (en) * | 2005-06-16 | 2006-11-10 | Георгий Георгиевич Ростиашвили | Agent of prolonged action for treatment of mouth cavity inflammation diseases |
| US20100080791A1 (en) * | 2008-09-26 | 2010-04-01 | Rousseau Robert A | Composition and Method For Treating Tissue Defects |
| WO2010117266A1 (en) * | 2009-04-06 | 2010-10-14 | Broockeville Corporation N.V. | In situ gelling alginate systems |
| WO2013071235A1 (en) * | 2011-11-13 | 2013-05-16 | Suneris Inc. | In-situ cross-linkable polymeric compositions and methods thereof |
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