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Clinical study to reduce the gum problem with use of cream and brushing solution.

Phase 2
Completed
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
Spontaneously reported and directly observed Adverse Events after first dose until End of treatment visit.Timepoint: 10 Days
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