Clinical study to reduce the gum problem with use of cream and brushing solution.
- Conditions
- Periodontosis,
- Registration Number
- CTRI/2014/08/004912
- Lead Sponsor
- Bonyf AG
- Brief Summary
A Multicenter, Open Label, Randomized, Clinical Study To Evaluate and Compare The Efficacy And Safety of Gingivial paste (Periocream) and brushing solution an adjunct to scaling and roots planning (SRP) with SRP alone in subjects suffering from chronic periodontitis. Gingival paste composed of Calcium/ Sodium PVM/MA copolymer and Olive Oil is applied once time as a coating over infected or healthy gums for 2-3 hours directly after treatment following SRP treatment. On next day 10 effervescent brushing tablets and container given to subjects along with instruction sheet with which subject have to brush their teeth. Clinical periodontal parameter & Clinical Performance parameter will be checked before and after treatment. Also Subgingingival plaque will be collected, pre and post treatment, for total bacterial count and analysis of four major periodontopathogenic bacteria. Data will be compare with control group subject who only had SRP treatment.
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- 1.Male or female subjects with 30-50 years of age (both inclusive).
- 2.Subjects suffering from chronic periodontitis and required medical device after scaling and root planning (SRP) in Non-chirurgical procedures.
- 3.Negative history of any systemic disease.
- 4.Willingness to comply with the study schedule and procedures.
- 1.Subjects with a history of allergy for content present in “PerioCreamâ€.
- 2.Subjects with Mobile, carious, endodontically treated teeth.
- 3.History of chronic liver disease, chronic renal disease, diabetic, Hyperthyroidism, severe anaemia, severe myasthenia, Active haemorrhage, Acute alcohol intoxication, Recent myocardial infarction).
- 4.Smokers and Tobacco users.
- 5.Subjects using any chemical plaque inhibitors.
- 6.Subjects suffering from condition requiring antibiotics prior to dental procedures or currently using antibiotics, anticoagulants, steroids, or any other medication which could alter the oral microflora.
- 7.Participation in any other clinical study during last 30 days.
- 8.Subject with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
- 9.Subject is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period, or is breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Tolerance based on clinical dermatological and dental criteria of the paste and tablets (irritation to mucus membrane) 10 days •Efficacy of brushing small tabs (considering oral Hygiene product) by determining Plaque index, gingival index, periodontal bleeding index and clinical attachment level. 10 days •Total bacterial count and analysis (before and after treatment with periocream) 10 days •Evaluation will be done on bases of questionnaire. 10 days
- Secondary Outcome Measures
Name Time Method Spontaneously reported and directly observed Adverse Events after first dose until End of treatment visit. 10 Days
Trial Locations
- Locations (2)
AMC Dental College
🇮🇳Ahmadabad, GUJARAT, India
College of Dental Sciences & Research centre
🇮🇳Ahmadabad, GUJARAT, India
AMC Dental College🇮🇳Ahmadabad, GUJARAT, IndiaDr Bela DavePrincipal investigator09979667676beladeve@gmail.com