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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  
Name  Address 
None  NA 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Oral health – Mukha Swasthya/Danta Swasthya 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: Twice Daily for 8 weeks, Ritucarya: , Acara Rasayana:, Other:TD58, Pathya/Apathya:no, Pathya:, Apathya:
2Intervention ArmLifestyle--Dinacarya: Twice Daily for 8 weeks, Ritucarya: , Acara Rasayana:, Other:CH21, Pathya/Apathya:no, Pathya:, Apathya:
3Intervention ArmLifestyle--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.
 
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