| CTRI Number |
CTRI/2021/07/034750 [Registered on: 12/07/2021] Trial Registered Prospectively |
| Last Modified On: |
27/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study on Dabur gel in reduction of oral malodor. |
|
Scientific Title of Study
|
Clinical study to evaluate the efficacy and safety of an oral care product on oral malodour reduction and its causative microflora in healthy adult subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarvesh Vijay |
| Designation |
Consultant Dentist |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
MS Clinical Research Pvt. Ltd,
327/15, 1st Main Road, Cambridge layout
Ulsoor, Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
sarvesh@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vedula Sasibhushan |
| Designation |
Senior Manager |
| Affiliation |
Dabur India Limited |
| Address |
Dabur India Limited,
Plot No.22, Site IV,
Sahibabad-201010,
Ghaziabad (U.P.),
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01204378614 |
| Fax |
01204552645 |
| Email |
sasibhushan.vedula@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Ritambhara |
| Designation |
Director |
| Affiliation |
MS Clinical Research PvtLtd |
| Address |
MS Clinical Research Pvt. Ltd,
327/15, 1st Main Road, Cambridge layout
Ulsoor, Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
ritambhara@mscr.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dabur India limited |
| Address |
Plot No.22, Site IV,
Sahibabad-201010,
Ghaziabad (U.P.),
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ritambhara |
MS Clinical Research |
Cambridge layout, Ulsoor, Bangalore
Bangalore
KARNATAKA |
08040917253
08041125934
ritambhara@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R196||Halitosis. Ayurveda Condition: Mukhadourgandhya, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gel toothpaste |
2-3 gm for brushing twice a day for 30 days |
| Comparator Agent |
Marketed comparator |
2-3 gm for brushing twice a a day for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
• Having at least 16 natural, permanent teeth.
• Subjects with bad oral hygiene and halitosis (self-reported or clinically diagnose). Subjects who have plague and dental caries.
• Subjects willing to give their swab samples for analysis.
• Subjects willing to follow 12 hr. overnight gap of brushing/mouthwash and 4 hr. fasting after brushing on day 30 assessment.
• Subjects willing to come for follow up visits at the specified time.
• Subjects ready to follow instructions during the study period.
• Subjects who use oral hygiene products other than Dabur.
• Subject able to read, understand and sign an appropriate informed consent form indicating willingness to participate.
|
|
| ExclusionCriteria |
| Details |
• A known history or present condition of hyper sensitivity to any toothpaste.
• The use of antibiotic, antimicrobial, analgesic medications, mouthwash or desensitizing toothpaste during the previous 1 month.
• Any history of periodontal therapy by surgical interventions.
• Any history of dentine hypersensitivity treatment. Subjects having moderate to severe dentine hypersensitivity.
• Orthodontic treatment with ï¬xed appliances.
• Any removable device such as a removable partial denture or orthodontic retainer.
• The presence of any ï¬xed appliance, large or defective restorations, cracked enamel,
• History of smoking or use of smokeless tobacco products.
• Subjects having moderate to severe dentine hypersensitivity.
• Subjects having abnormal frenum attachment.
• Subjects who are pregnant, lactating or nursing.
• Subjects having severe level of calculus and/ tartar.
• Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Significant reduction in malodour causing Bacteria by CFU log reduction at various time points in comparison to the baseline and with comparator.
• Significant reduction in malodour by Oral Chroma assessment at various time points in comparison to the baseline and with comparator.
• Significant reduction (X%) in oral microflora with product use and with comparator.
|
Day 1-T0,Timm, Day30-T0, Timm, T4hr and T12hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Significant reduction in plaque, gingivitis, bleeding index and oral hygiene index with regular use of test product at various time points in comparison to the baseline and with comparator.
|
Day1-T0,Timm, Day30-T0,Timm |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "161"
Final Enrollment numbers achieved (India)="161" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/07/2021 |
| Date of Study Completion (India) |
20/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The current clinical study is planned to compare the efficacy and safety of an oral care product in reducing the oral malodour in comparison to a marketed comparator. The study is planned in male and female healthy subjects aged 18-55 years having clinically diagnosed oral malodour. Both microbiological and biochemical parameters are used to assess the reduction in oral malodor. Assessment is done forrReduction in malodour causing Bacteria by CFU log reduction at various time points in comparison to the baseline and with comparator and reduction in malodour by Oral Chroma assessment at various time points in comparison to the baseline and with comparator. Other key parameters of oral hygiene like plaque index, gingival index, gum bleeding index and oral hygiene index will be assessed for reduction at various time points in comparison to baseline and marketed comparator. The sample size of for each group will be 30 completed subjects and study intervention period will be one month.
|