CTRI Number |
CTRI/2022/02/040692 [Registered on: 28/02/2022] Trial Registered Prospectively |
Last Modified On: |
02/12/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [Ayurvedic Proprietary Medicine] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A study to test the benefits of the Product on dental problems |
Scientific Title of Study
|
A study to evaluate the efficacy of the test product in providing short term and long-term relief from dental Problems |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
ORAL/URDH/2021-22 Version 1.0 Dated 03 Feb 2022 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Lakshmi Chandra |
Designation |
Principal Investigator |
Affiliation |
MS Clinical Research Pvt Ltd |
Address |
Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor
Bangalore KARNATAKA 560008 India |
Phone |
08041125934 |
Fax |
08040917253 |
Email |
lakshmi@mscr.in |
|
Details of Contact Person Scientific Query
|
Name |
Ritambhara |
Designation |
Director- Business and Operation |
Affiliation |
MS Clinical Research Pvt Ltd |
Address |
Room no.2, Ground floor,327/15, 1st Main Road Cambridge layout,
Ulsoor
Bangalore KARNATAKA 560008 India |
Phone |
08041125934 |
Fax |
08040917253 |
Email |
ritambhara@mscr.in |
|
Details of Contact Person Public Query
|
Name |
Sudhanthiran S |
Designation |
Study Manager |
Affiliation |
MS Clinical Research Pvt Ltd |
Address |
First Floor, Room no. 1, Councelling Area, 327/15, 1st main road, cambridge layout, Ulsoor
Bangalore KARNATAKA 560008 India |
Phone |
08041125934 |
Fax |
08040917253 |
Email |
sudhan@mscr.in |
|
Source of Monetary or Material Support
|
Unilever Industries Pvt Ltd |
|
Primary Sponsor
|
Name |
Unilever Industries Pvt Ltd |
Address |
Unilever Industries (P) Ltd Research Center Stores B.D Sawant
Marg, Chakala Andheri (East) Mumbai – 400099, India |
Type of Sponsor |
Other [FMCG(Fast moving Consumer Goods)] |
|
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 |
Dr Lakshmi Chandra |
MS Clinical Research Pvt. Ltd. |
Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor Bangalore KARNATAKA |
08041125934 08040917253 lakshmi@mscr.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Clinicom Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Oral health – Mukha Swasthya/Danta Swasthya |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice Daily for 8 weeks, Ritucarya: , Acara Rasayana:, Other:TD58, Pathya/Apathya:no, Pathya:, Apathya: | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice Daily for 8 weeks, Ritucarya: , Acara Rasayana:, Other:CH21, Pathya/Apathya:no, Pathya:, Apathya: | 3 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice Daily for 8 weeks, Ritucarya: , Acara Rasayana:, Other:GL96, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.Healthy male and female subjects between 18 to 65 years of age.
2.Subjects having atleast 16 natural, permanent teeth and one or two teeth with dental problems as per oral examination.
3.Subjects willing to report to site on visit 2 without a mouth wash/brushing. Last brushing and mouth wash should be on the previous night i.e., atleast 12 hours prior to baseline assessment.
4.Subjects willing to maintain atleast 1 hour difference between last food/drink and the assessments.
5.Subjects willing to come for follow up visits at the specified time.
6.Subjects ready to follow instructions during the study period.
7.Subjects willing to give a voluntary written informed consent for activities in the study and agree to come for regular study visits
8.Subjects willing to abide and comply with the study protocol
9.Subjects who are willing not to participate in any other oral/dental study during participation in the current study.
10.Subjects agreeing to use only the given test product/washout product and refrain from the use of any non-study oral hygiene products. |
|
ExclusionCriteria |
Details |
1.Subjects using anti-inflammatory, antibiotic, antimicrobial, analgesic medications or psychotropic drug.
2.Any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the baseline visit
3.Subjects who have undergone dental prophylaxis within 2 weeks prior to baseline visit
4.Any history of periodontal therapy, orthodontic treatment or teeth restored in the preceding three months by surgical interventions.
5.Any removable device such as a removable partial denture or orthodontic retainer.
6.The presence of any fixed appliance, large or defective restorations, cracked enamel,
7.History of smoking or use of smokeless tobacco products.
8.Subjects having abnormal frenum attachment.
9.Subjects who are pregnant, lactating or nursing.
10.Subjects having severe level of calculus and/ tartar.
11.Subjects having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GRED or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity
12.Subjects with history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn’s disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain food or nutrients.
13.Subjects with any diseases or conditions that might interfere with the safe participation in the study.
14.Subjects unable to undergo study procedures.
15.Subjects with severe xerostomia
16.Subjects having active caries within 12 months.
17.Subjects having high risk for caries development (rampant caries, multiple dental restorations, crown with compromised margins) per examiners discretion.
18.The subject is an employee of Unilever or the site conducting the study. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Significant improvement in tooth and gum health |
Day 1, week 2, week 4 and week 8 |
|
Secondary Outcome
|
Outcome |
TimePoints |
Significant improvement in overall oral health -plaque and whole mouth protection. |
Day 1, week 2, week 4 and week 8 |
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "193"
Final Enrollment numbers achieved (India)="193" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/03/2022 |
Date of Study Completion (India) |
01/06/2022 |
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
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Study will be conducted to assess the efficacy of test product in improving overall oral/dental health. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. Post wash out period, test product will be dispensed to subjects and post baseline assessment subjects will be instructed to use the product for 2 month period. Evaluation assessments will be done at different times points over a period of 8 weeks. |