Clinical study to reduce the gum problem with use of cream and brushing solution.
- Conditions
- Health Condition 1: null- Chronic Periodontitis who need Scaling and Root planningHealth Condition 2: K054- Periodontosis
- Registration Number
- CTRI/2014/08/004912
- Lead Sponsor
- Bonyf AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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 â??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 â?¢Tolerance based on clinical dermatological and dental criteria of the paste and tablets (irritation to mucus membrane) <br/ ><br>â?¢Efficacy of brushing small tabs (considering oral Hygiene product) by determining Plaque index, gingival index, periodontal bleeding index and clinical attachment level. <br/ ><br>â?¢Total bacterial count and analysis (before and after treatment with periocream) <br/ ><br>â?¢Evaluation will be done on bases of questionnaire.Timepoint: 10 days
- Secondary Outcome Measures
Name Time Method Spontaneously reported and directly observed Adverse Events after first dose until End of treatment visit.Timepoint: 10 Days