DIPLEN DENTA X
Polymer dental self-adhesive double-layer film with chlorhexidineRegistration certificate no. FSR 2008/02392, issued by Nord-Ost LLC, Moscow. RF.
COMPOSITION AND FORM OF RELEASE
1 sq. cm of DIPLEN DENTA X film 0.02-0.06 mm thick contains chlorhexidine bigluconate 0.01-0.03 mg.
PROPERTIES AND ACTION
DIPLEN DENTA X is a two-layer film consisting of combined hydrophilic and hydrophobic layers. It is intended for topical application. It has a pronounced antiseptic effect due to the presence of chlorhexidine bigluconate in the film. DIPLEN DENTA X hydrophilic (adhesive) the side is tightly fixed on the moist mucous membrane, wound, burn, etc. It is stored on various surfaces and lasts for several hours. The affected area is hermetically isolated from the environment, secondary infection of the wound is excluded, and an active and selective effect of the therapeutic factor on the lesion site is carried out. The film is transparent, which allows you to observe the process without removing it. The outer (hydrophobic) layer prevents the film components from entering the oral cavity, prevents the components of the oral fluid from entering the film area, and also allows patients to maintain oral hygiene during treatment. The use of DIPLEN DENTA X film in the treatment of various infectious and inflammatory diseases of the oral cavity and gums, postoperative wounds, burns, etc. It leads to the disappearance or significant decrease in the number of aggressive bacterial species. At the same time, DIPLEN DENTA X has practically no negative effect on the resident microflora of the oral cavity (S. Sangis, Corynebacterium sp.). After applying the film, species such as Prevotella melaninogenica and Provetella actinomyces israeli are not detected in the contents of the periodontal pockets. Fusobacterium necroferum and Prevotella oralis disappear on the third day of application of the film, Actinomyces - on the seventh.The film is very easy to use, patients can apply the film themselves according to the course prescribed by the doctor.
INDICATIONS FOR USE
• Periodontitis in the acute phase, gingivitis, stomatitis: aphthous, ulcerative necrotic and resulting from wearing dentures.
• Infectious diseases of the oral cavity.
• Other acute and chronic forms of gum inflammation.
• Postoperative wounds, injuries, burns in the oral cavity, etc.
• Intraosseous dental implantation.
METHOD OF APPLICATION
Before starting treatment with DIPLEN DENTA X film, supra- and subgingival dental deposits are removed and curettage is performed according to indications. The application of films is carried out as follows: a strip of 50 mm long and 10 mm wide (or another convenient size) is cut off and applied with the adhesive side to the gum. As a rule, the first 2-3 applications are carried out in a clinical setting with simultaneous training of patients in the technique of their independent use. If no special medical supervision is required, patients are prescribed to apply the film themselves (preferably overnight) for this stage of treatment: It is recommended to apply the film daily in 4 quadrants after brushing your teeth 1 or 2 times a day.
RECOMMENDED COURSE OF TREATMENT
• Gingivitis and periodontitis of mild degree. In most cases, 5-8 applications are sufficient to eliminate inflammatory phenomena in the gum tissues. Follow-up examinations are carried out 1, 3, 6 and 12 months after the end of the course of treatment.
• Periodontitis of moderate severity. The course of treatment with DIPLEN DENTA X film varies from 6 to 10-11 days. In the case of a relatively successful course of the process, when periodontal pockets up to 6 mm deep are detected in the area of individual teeth, patients are recommended to apply films from the vestibular surface once a day. In patients with signs of activity and generalization of the inflammatory process in the marginal periodontium, the film is additionally applied from the lingual surface of the lower jaw and from the palatine surface of the upper jaw. In patients with a similar course of the disease, the duration of treatment reaches 14-15 days.
• Severe periodontitis. Films are used in combination with other periodontal measures. Treatment tactics are determined individually for each patient. The greatest difficulties are encountered in the treatment of patients with chronic periodontitis in the acute stage, when, in addition to a pronounced inflammatory reaction, suppuration from periodontal pockets is noted. In this case, it is advisable to carry out a preliminary stage of treatment. It is carried out with films of DIPLEN DENTA L or DIPLEN DENTA M: twice a day (after morning and evening brushing), a film of DIPLEN DENTA L or DIPLEN DENTA M is applied to the gum from the vestibular and oral sides. Such procedures are carried out within 3-5 days, depending on the patient's condition and well-being.
As a rule, this is enough to relieve acute inflammatory phenomena, sharply reduce or stop suppuration from periodontal pockets, which allows you to begin removing supra- and subgingival dental deposits and removing granulations. After that, they begin the main course of treatment. The course of treatment of severe periodontitis with DIPLENT X films averages 17-20 days. A good treatment effect is achieved by combining DIPLEN DENTA X with DIPLEN DENTA M or DIPLEN DENTA L.
When used in combination, it is advisable to start treatment with DIPLEN DENTA M or DIPLEN DENTA L films, which are applied to the gum twice a day for 6-8 days, and then treatment with DIPLEN DENTA X films continues for 9-14 days. Alternating films of different brands is effective under the condition of continuous use of films of the same type for at least 6-8 days. During treatment, it is recommended to insert DIPLEN DENTA L or DIPLEN DENTA M films into the periodontal pockets in small pieces.
• Burns. On the first day of oral burns, the phenomenon of dysbiosis develops, manifested in an increase in the number of anaerobes and a redistribution of the ratio of species in microbial associations. Bacilli and fungi begin to develop, which indicates a weakening of local immunity. Against the background of damage to the oral mucosa, these changes are even more pronounced. A film of DIPLEN DENTA X is applied to the affected surface, overlapping it by 1-2 mm on each side. The film is well modeled on the wound surface, fits snugly to its bottom without additional fixation. Due to transparency, the film coating provides the possibility of visual monitoring of the wound condition without changing bandages. During bandaging, the remaining part of the film is removed. As a rule, on the seventh day of applying films, the composition of the microflora approaches the physiological norm.
The film creates favorable conditions for regeneration and epithelialization processes.
• Prevention of inflammatory complications. DIPLEN DENTA X film is used after surgical interventions on periodontal tissues to suppress pathogenic microflora in the surgical area, isolate and mechanically protect postoperative wounds from external influences.
During operations of intraosseous dental implantation, the film is applied in the area of the postoperative suture daily for 5-8 days for 10-12 hours. During bandaging, the remaining part of the film is removed. During dynamic monitoring of the wound process under the film, it was found that the development of microflora does not occur under it, which indicates satisfactory protective properties of the film coating. The film absorbs a moderate amount of wound discharge and functions on the wound without compromising integrity, providing favorable conditions for subsequent regeneration and epithelialization.
LONG-TERM RESULTS
• Gingivitis and periodontitis of mild degree. There is a persistent clinical effect of treatment for 6 months, which persists in some patients for up to one year. A second course of treatment is prescribed after 9-12 months.
• Moderate to severe periodontitis. 6 months after the end of treatment, approximately 50% of patients need to undergo repeated treatment, but the amount of medical intervention required at this stage is significantly less than at their initial treatment. As a rule, removal of only supragingival tartar is required in the absence or minimal amount of subgingival dental deposits; the removed tartar has a looser structure, is less mineralized and is not as tightly bound to the tooth tissues as before treatment. The repeated course of treatment is usually much shorter than the initial one.
SIDE EFFECT
In rare cases, allergic reactions to the components of the film.
contraindications
Hypersensitivity to film components.
PACKAGING
There is one 50x100 mm film in an airtight plastic package.
STORAGE CONDITIONS
The films should be stored in their original packaging. The remaining part of the DIPLENE DENTA X film is put back into a packaging bag, inserted into an envelope and stored in a dry, cool place protected from light. Do not use the film after the expiration date. Keep out of reach of children.
Manufacturer of the drug
The film is produced by the NORD-OST company, Moscow, Russia.
EXPIRATION DATE CONDITIONS OF RELEASE FROM PHARMACIES
2 years. It is indicated on the package. Over-the-counter vacation.