| CTRI Number |
CTRI/2011/05/001774 [Registered on: 31/05/2011] Trial Registered Retrospectively |
| Last Modified On: |
30/09/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Non-inferiority trial for treatment of mild to moderate gingivitis. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CTRI/2011/05/001774 |
Other |
| ORO BIOEQ-2010 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anirban Chatterjee |
| Designation |
Prinicipal Investigator |
| Affiliation |
|
| Address |
Apollo Hospital, Bannerghatta Road,
Bangalore
KARNATAKA
560076
India |
| Phone |
080-41206229 |
| Fax |
080-41463151 |
| Email |
dranirbanchatterjee@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Anirban Chatterjee |
| Designation |
|
| Affiliation |
|
| Address |
Apollo Hospital, Bannerghatta Road,
Bangalore
KARNATAKA
560076
India |
| Phone |
080-41206229 |
| Fax |
080-41463151 |
| Email |
dranirbanchatterjee@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Parijat Nandy |
| Designation |
Clinical Development, Director, Semler Research Center |
| Affiliation |
Semler Research Center |
| Address |
Semler Research Center, JP Nagar 1st Phase,
NA
Bangalore
KARNATAKA
560078
India |
| Phone |
080-42627200 |
| Fax |
080-26640683 |
| Email |
parijatnandy@semlerresearch.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Germiphene cooperation, 1379, Colborne Street East, Brantford, ON, N3T 5M1,Canada |
|
Primary Sponsor
Modification(s)
|
| Name |
Germiphene Corporation |
| Address |
Germiphene Corporation
1379, Colborne Street East, Brantford, ON, N3T 5M1 (Canada
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Semler Research Center Pvt Ltd |
75A , 15th cross ,1st phase J.P Nagar, Bangalore 560078, India
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anirban Chatterjee |
Apollo Hospital, Bannerghatta Road |
Apollo Hospital, Opp. IBM, Bannerghatta Road
Bangalore
KARNATAKA |
080-40304050
080-41463151
aherfbng@gmail.com |
| Dr Savitha AN |
Dental and facial surgical center |
Hosur main Road, madiwala,
Bangalore
KARNATAKA |
080-40416789
080-64562243
sunilc_06@hotmail.com |
| Dr Vijayendra R |
RV Dental College, |
DAPM RV Dental College, JP Nagar 1st Phase,
Bangalore
KARNATAKA |
09845155952
dr_vijayendra@yahoo.com |
| Dr Rashmi Bade |
Santosh Hospital |
6/1 Promenade road, Near Coles park
Bangalore
KARNATAKA |
9945620630
080-41252502
santoshhospi@sify.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| IEC Consultants/Bangalore/Dr. Rashmi Bada, Darusalam,598,2ndCross,17th Main, 3rd Block,Koramangala,Bangalore-560034, India |
Approved |
| IEC Consultants/Bangalore/Dr. Savitha A. N,Darussalam,598,2ndCross,17th Main, 3rd Block,Koramangala,Bangalore-560034, India |
Approved |
| IRB, Apollo Hospital,154/11, Opp I.I.M, Bannerghatta Road, Bangalore-560 076 |
Approved |
| IRB, Rashtreeya Sikshana Samithi trust , D.A Pandu Memorial R.V Dental College, No CA 37, 24th Main, 1st Phase, J.P.Nagar, Bangalore-560 078 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
mild to moderate gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
orocleanse - oral rinse solution |
15ml twice daily
Chlorhexidine Gluconate is available as Chlorhexidine Gluconate Solution, USP. It is an almost colorless to pale straw-colored, clear or slightly opalescent liquid that is odourless or almost odourless. It is miscible with water, with not more than five parts of ethanol (96%) and with not more than three parts of acetone. The pH of a 5% v/v solution is 5.0 to 7.0 of OROCLENSE and ORO-CLEAR (0.12% Chlorhexidine Gluconate Oral Rinse). Both products are available in 4 L containers impermeable to light. The product will be dispensed in 500 ml bottles for each patient. Patients will be provided with a measuring cup.
5.2 Treatment Regimen
Rinse with 15 ml of solution for 30 (thirty) seconds, then expectorate. Use twice daily after breakfast and before bedtime and do not eat or drink for 30 minutes after treatment. This is to be recorded on a patient compliance sheet. OROCLEANSE and OROCLEAR are not intended for ingestion and should be expectorated after rinsing. A wait of thirty minutes is required after brushing with toothpaste before using the test products.
|
| Intervention |
oroclear -oral rinse solution |
15 ml twice daily
Chlorhexidine Gluconate is available as Chlorhexidine Gluconate Solution, USP. It is an almost colorless to pale straw-colored, clear or slightly opalescent liquid that is odourless or almost odourless. It is miscible with water, with not more than five parts of ethanol (96%) and with not more than three parts of acetone. The pH of a 5% v/v solution is 5.0 to 7.0 of OROCLENSE and ORO-CLEAR (0.12% Chlorhexidine Gluconate Oral Rinse). Both products are available in 4 L containers impermeable to light. The product will be dispensed in 500 ml bottles for each patient. Patients will be provided with a measuring cup.
5.2 Treatment Regimen
Rinse with 15 ml of solution for 30 (thirty) seconds, then expectorate. Use twice daily after breakfast and before bedtime and do not eat or drink for 30 minutes after treatment. This is to be recorded on a patient compliance sheet. OROCLEANSE and OROCLEAR are not intended for ingestion and should be expectorated after rinsing. A wait of thirty minutes is required after brushing with toothpaste before using the test products.
|
| Comparator Agent |
placebo |
PLacebo is a material which has no therapeutic constitutents but looks like the test/refernce drug. has no therapeutic effects.
15 ml twice daily |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
Method of Generating Random Sequence
Modification(s)
|
Permuted block randomization, fixed |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| Stain indices |
Periodic |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/04/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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=0.05 Conclusion--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. |