on-inferiority trial for treatment of mild to moderate gingivitis.

Phase 3

Completed

• Conditions: Health Condition 1: null- mild to moderate gingivitis

• Registration Number: CTRI/2011/05/001774
• Lead Sponsor: Germiphene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1.Subjects should have reasonable standard of oral hygiene with no severe gingivitis (score of not 2 on the Gingival Index). Basically subjects with mild to moderate gingivitis are considered.

2.Subjects should have probing depths of not more than 3mm.

3.Subjects should have a minimum of 20 natural teeth.

4.Subjects should have no physical limitations or restrictions that might preclude normal oral hygiene procedures such as toothbrushing.

5.Subjects should have no history of adverse reactions to mouthrinses or any of the ingredients in the said formulations.

6.Subjects should not have been using another prophylaxis rinse. If so then a 14 day washout period is required before induction into the clinical trial.

7.Subjects should be capable of providing their consent or if appropriate, have an acceptable surrogate capable of giving consent on the subject?s behalf to participate in the clinical trial after being given adequate information pertaining to the study.

8.Note: subjects that smoke or have diabetes should be considered within the study and effort should be made to obtain statistical significance. This is inclusive for pediatric (greater than 12 years old ? refer to point 9) and geriatric patients.

9.Pediatric patients should have good general health, a minimum of 12 gradable teeth, agreement to delay any elective dental treatment, including oral prophylaxis during the course of the study. Age minimum of 12 years old.

Exclusion Criteria

1.Subjects with severe gingivitis or who have probing depths exceeding 3mm and alveolar bone loss.

2.Periodontitis as indicated by clinical attachment loss, radiographic alveolar bone loss, or periodontal pockets greater than 5 millimeters. Or history of early-onset periodontitis or acute necrotizing ulcerative gingivitis.

3.Concomitant endodontic or periodontal therapy other than prophylaxis in the last 6 months.

4.Gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaques or calculus, or soft or hard tissue tumor of the oral cavity.

5.Subjects who have consumed antibiotics in the past 6 months or having a conditions requiring antibiotic prophylaxis such as heart murmurs, pacemakers, prosthetic heart valves, as well as non-oral prosthetic implants.

6.History of rheumatic fever, congenital heart disorders, prosthetic heart valves or any other conditions requiring antibiotics prior to dental treatment.

7.Chronic disease with concomitant oral manifestations.

8.Orthodontic appliances or removable partial dentures.

9.Chronic treatment (2 weeks or more) with any medication known to affect periodontal status (including phenytoin, calcium antagonists, cyclosporine, coumarin, nonsterioidal anti-inflammatory drugs, and aspiring) within 1 month of the screening examination. All other medications for chronic medical conditions have been initiated at least 3 months before enrollment.

10.Homeless persons or those with active drug/alcohol dependence or abuse history.

11.Medical conditions or significant laboratory abnormalities that the investigator considers significant and that may compromise the subjects safety.

12.Subjects whose manual dexterity is compromises e.g. handicapped or post-stroke patients.

13.Subjects with known sensitivities to any of the formulation ingredients and to CHG.

Study & Design

• Study Type: Interventional
• Study Design: Not specified