RU171124U1 - DEVICE FOR PREVENTION OF ACCIDENTAL COMPLICATIONS IN PATIENTS WITH MALIGNANT NON-FORMATIONS OF THE MAXILLOFACIAL REGION - Google Patents

Abstract

The utility model relates to medicine, namely to oncology and dentistry, and can be used to prevent post-radiation osteonecrosis of the jaw, reduce the concentration of ionizing radiation directed to healthy tissues, and also to stabilize the position of the lower jaw and fixation of the tongue during radiation therapy in patients with maxillofacial malignant neoplasms. A device is proposed for the prevention of postradiation complications in patients with maxillofacial malignancies of the area, which is an individually made splint of the lower jaw made of transparent bioinert material with a shield-plate located above the tongue for fixing the tongue and spacers protruding above the occlusal surface of the teeth to ensure stabilization of the position of the jaws with the patient’s open mouth during the ionizing radiation procedure, and also allowing reduce the number of complications at the stage of antitumor treatment of patients with malignant neoplasms of the maxillofacial region.

Description

The utility model relates to medicine, namely to oncology and dentistry, and can be used to prevent post-radiation osteonecrosis of the jaw, reduce the concentration of ionizing radiation directed to healthy tissues, and also to stabilize the position of the lower jaw and fixation of the tongue during radiation therapy in patients with malignant neoplasms of the maxillofacial region.

A device for the prevention of local radiation reactions of the tongue in the form of a mouthguard to the lower dentition with a jumper between the teeth of the lower jaw, modeled on the imprint of the tongue, for reliable fixation of the tongue to the bottom of the oral cavity (RU No. 88555, A16N 05/00, 20.11.2009) .

However, this device is not able to isolate the opposite jaw with healthy tissues from the effects of the pathological properties of radiation exposure.

A device for the prevention of local radiation reactions of the teeth, representing a plastic mouthguard for the entire dentition, with a lead plate inserted into it, modeled on the impression from the dentition (RU No. 90335, A16N 05/00, 01/10/2010), however, this device also unable to isolate healthy tissues of the opposite jaw from the effects of the pathological properties of radiation exposure.

A device is known for preventing the toxic effects of ionizing radiation and cytostatics on the mucous membranes and periodontium of the oral cavity, comprising a mouthguard, characterized in that a flexible tube with a diameter of 5-7 mm with water circulating through it connected through a temperature regulator with cold tap water is soldered in an individual mouthguard and hot water (RU No. 137714, A16N 05/00, 02/27/2014).

The disadvantage of this utility model is the unstable position of the lower jaw during the radiation therapy procedure, and, therefore, the possibility of uncontrolled involvement of the healthy maxillofacial region in the irradiation process.

A device for the prevention of post-radiation xerostomia in the treatment of malignant tumors of the oral cavity, which contains a headband, at the ends of which are bolted plastic cups in the form of hemispheres that cover the parotid glands, the cups have an x-ray protective coating on the inside and a sealing roller around the perimeter (RU No. 140932, A61B 18/18, 05/20/2014), however, the device does not have a protective effect on healthy tissues of the oral cavity.

For the closest analogue of the proposed device, the closest in technical essence and achieved effect device for breeding jaws with a step for the tongue was chosen. [Nurieva N.S. Abstract dis. Cand. honey. Sciences: 18.04.2006.//Chelyabinsk, 2006, p. 19].

The disadvantage is that the ledge, due to its small length, does not provide a clear position of the tongue, leaving the possibility for its displacement, as well as the unstable position of the jaws during irradiation sessions.

Objective: to reduce the concentration of radiation for the prevention of post-radiation osteonecrosis and radiation damage to the hard tissues of the teeth.

The technical result is achieved by creating a device for the prevention of post-radiation osteonecrosis of bone structures, ensuring reliable stabilization of the lower jaw and fixation of the tongue during radiation therapy sessions, as well as to simultaneously reduce the concentration of ionizing radiation on surrounding healthy tissues.

The essence of the proposed device is the manufacture of a transparent bioinert material of an individual tire on the lower jaw with a shield-plate located above the tongue for fixing the tongue and spacers protruding above the occlusal surface of the teeth to ensure stabilization of the position of the jaws with the patient's mouth open during the ionizing radiation procedure.

To make an individual tire, an impression is taken from the lower jaw using an alginate mass, and the model is cast from super gypsum. Then, to form the spacers, the patient closes his mouth with bite columns of silicone mass to a height controlled by a doctor, after which ready-made silicone spacers are applied to the gypsum model of the lower jaw and excess silicone mass is removed with a scalpel.

Next, a plate of bioinert material (Duran, Placas para Plastificadoras a vacuo) is heated to a plastic state and, using a vacuum mold (Plastvac P7), the gypsum model of the lower jaw is pressed together with the fixed silicone spacers to a snug fit, and then cooled. Then there is an overlay and correction of the manufactured structure in the oral cavity.

The transparency of the manufactured tire allows you to control the position of the tongue to ensure its removal from the irradiation zone.

For a better understanding, the proposed device is depicted in a general view in FIG. 1, where 1 is the alveolar part of the tire, 2 is a shield plate for fixing the tongue, 3 are spacers.

The manufacture of the device in the form of a tire on the lower jaw, clearly reflecting the relief of the dentition or toothless alveolar process, allows you to accurately fix the device in the patient’s oral cavity, thereby eliminating the need to control the position of the tongue.

The proposed device can be manufactured in any dental offices in the presence of standard equipment and materials of domestic or foreign production.

The patient before the radiation therapy session independently installs the device on the teeth or toothless alveolar processes, fixing the tongue under it.

The proposed device in comparison with analogues has the following properties:

providing not only mechanical protection of the mucous membrane and bone structures of the lower jaw, but also due to the available spacers, removing healthy tissues of the opposite jaw from the irradiation zone;

ease of use, consisting in the absence of the need to control the position of the tongue by the patient during the irradiation procedure;

prevention of post-radiation osteonecrosis as a complication at the stage of antitumor treatment;

fixation of the tongue in the oral cavity, which provides an obstacle to its chaotic movements and involuntary swallowing during radiation therapy sessions;

multiple use;

the possibility of using after surgical treatment of malignant neoplasms of the maxillofacial region due to the individual approach to manufacturing;

hypoallergenicity of the materials used;

simplicity, as well as the cost-effectiveness of manufacturing.

A clinical study was conducted with the participation of 14 people, conditionally divided into two groups of 7 people. In the first group, antitumor treatment was carried out using the proposed device.

After a year, 7 patients of the first group and 7 patients of the second group were examined. It was revealed that due to ionizing radiation in those patients who used the proposed device, only 13% of the teeth were affected by radiation caries.

While in patients of the other group, the degree of radiation damage to caries was equal to 94%. Osteonecrosis of the jaws was diagnosed in 5 of 7 people in group 2.

The device is used as follows: fix in the patient’s oral cavity for the duration of the irradiation session - first the alveolar part [1], then the shield plate for the tongue [2], and fix the position of the jaws using spacers [3], and then remove the tire until the next stage radiation therapy.

Example.

A 46-year-old patient M. was admitted after several chemotherapy sessions (Cisplatin 100 mg / m ² , Cetuximab 250 mg / m ² a week before radiation therapy) with a diagnosis of oral mucosal cancer (T ₁ N ₀ M ₀ ).

Complaints: dry mouth, difficulty swallowing.

Objectively: a face without visible asymmetry, nasolabial folds are moderate, regional lymph nodes without pathology. Partial lack of teeth on the upper and lower jaws, the mucous membrane of the oral cavity, lips are pale, dry.

Treatment. Before the radiation therapy session (total dose of 50 g), the proposed device was fixed on the lower jaw to the patient. After the end of each session, the tire is removed.

After 3 months, the patient complained of slight dryness in the oral cavity. A moderate amount of over- and subgingival dental deposits on the upper and lower jaws was objectively determined; the oral mucosa was pale and moderately dry.

Thus, when using the proposed device, a reduction in complications during radiation therapy is achieved and ultimately improves the quality of life of patients.

The device is convenient to use and allows to reduce the number of complications at the stage of antitumor treatment, such as jaw osteoradionionecrosis, mucositis, radiation caries, in patients with malignant neoplasms of the maxillofacial region.

The proposed device can be recommended in clinical practice for the complex treatment of malignant neoplasms of the maxillofacial region in order to prevent complications after radiation therapy.

Claims (1)

A device for the prevention of postradiation complications in patients with malignant neoplasms of the maxillofacial region, which is a splint on the lower jaw individually made of transparent bioinert material with a shield plate located above the tongue to fix the tongue and spacers protruding above the occlusal surface of the teeth to ensure stabilization of the position of the jaws open patient’s mouth during ionizing radiation procedure.

Images