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

A Multicenter, Open Label, Randomized, Clinical Study to evaluate and Compare the Efficacy and Safety of Gingivial Paste (Periocream) and Brushing Solution manufactured by Bonyf AG as an adjunct to scaling and roots planning (SRP) with SRP alone in subjects suffering from chronic periodontitis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/08/004912

Enrollment

Registered

2014-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Periodontitis who need Scaling and Root planning Health Condition 2: K054- Periodontosis

Interventions

Intervention1: Gingival Paste (PerioCream) and Brushing Solution: Gingival paste is applied once time as a coating over infected or healthy gums for 2-3 hours directly after treatment following SRP tr

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
â?¢Tolerance based on clinical dermatological and dental criteria of the paste and tablets (irritation to mucus membrane) â?¢Efficacy of brushing small tabs (considering oral Hygiene product) by determining Plaque index, gingival index, periodontal bleeding index and clinical attachment level. â?¢Total bacterial count and analysis (before and after treatment with periocream) â?¢Evaluation will be done on bases of questionnaire.Timepoint: 10 days	—

Measure

Time frame

â?¢Tolerance based on clinical dermatological and dental criteria of the paste and tablets (irritation to mucus membrane) â?¢Efficacy of brushing small tabs (considering oral Hygiene product) by determining Plaque index, gingival index, periodontal bleeding index and clinical attachment level. â?¢Total bacterial count and analysis (before and after treatment with periocream) â?¢Evaluation will be done on bases of questionnaire.Timepoint: 10 days

—

Secondary

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

Countries

India

Contacts

Public ContactDr Milan Satia

Ethicare Clinical Trial Services

milansatia@ethicare-cro.com09825585119

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026