Non-inferiority trial for treatment of mild to moderate gingivitis.
- Conditions
- mild to moderate gingivitis
- Registration Number
- CTRI/2011/05/001774
- Lead Sponsor
- Germiphene Corporation
- Brief Summary
Title: Non-inferiority efficacy study of 2 different formulations of 0.12% Chlorhexidine gluconate oral rinse with (Oroclense) and without alcohol (Oroclear) for treatment of gingivitis. Short Title Non-inferiority Efficacy Oroclense and Oroclear. Protocol Number ORO-BIOEQ-2010 Version: 01 Phase Non-inferiority Efficacy Methodology Double Blind, Randomized, Parallel Study Duration 6 months with interim evaluation at 3 months Study Center(s) Multi-center Objectives Non-inferiority efficacy comparison of Oroclear and Oroclense in the treatment of gingivitis. Number of Subjects 120 recruitment with estimate of 20% potential drop out; 96 evaluable subjects required Diagnosis and Main Inclusion Criteria Gingivitis Study Product, Dose, Route, Regimen Oroclear 15 ml 2 x day for 6 months of 0.12% Chlorhexidine gluconate Duration of administration 6 months Reference therapy Oroclense formula (equivalent to US Peridex formulation) containing alcohol is the globally established golden standard for efficacy. A placebo arm will be included as well. Statistical Methodology Pearson?s chi-square test for statistical significance. P=0.05Conclusion--Both Oroclear and Oroclense antimicrobial mouth rinses were considered as safe and
effective when used in conjunction with regular self-performed oral hygiene measures
in patients with moderate gingivitis. Oroclear was found non-inferior to Oroclense in
treatment of gingivitis.
No statistical significant difference in mean change of GI, PI, PBI, and CI
were observed from Screening to Month 4 and 7 visits between 3 treatment
groups. Due to limited sample size, the study did not have sufficient power to
detect differences between the active treatments and placebo in any of the
efficacy endpoints.
Significant reduction in mean GI, PI, PBI, and CI scores were observed from
Screening to Month 4 and 7 visits within all 3 treatment groups. None of the
subject had severe stain index score at Screening, Month 4, and 7 visits.
Four (3.4%) subjects reported 5 AEs - aphthous stomatitis, mouth ulceration,
gingival bleeding, paraesthesia oral and tongue disorder and all were
recovered.
No deaths or SAE was reported.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
- 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.
- 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
- Primary Outcome Measures
Name Time Method The proportionate reduction for GI measurements is the comparison of the active Test therapy to the Reference therapy at the end of the study periodic over a span of 7 months
- Secondary Outcome Measures
Name Time Method Stain indices Periodic
Trial Locations
- Locations (4)
Apollo Hospital, Bannerghatta Road
🇮🇳Bangalore, KARNATAKA, India
Dental and facial surgical center
🇮🇳Bangalore, KARNATAKA, India
RV Dental College,
🇮🇳Bangalore, KARNATAKA, India
Santosh Hospital
🇮🇳Bangalore, KARNATAKA, India
Apollo Hospital, Bannerghatta Road🇮🇳Bangalore, KARNATAKA, IndiaDr Anirban ChatterjeePrincipal investigator080-40304050aherfbng@gmail.com