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CTRI Number  CTRI/2023/09/057967 [Registered on: 22/09/2023] Trial Registered Prospectively
Last Modified On: 20/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Evaluation of two commercially available toothpastes on Glucosyltransferase Enzyme  
Scientific Title of Study   Comparative Evaluation of two commercially available toothpastes on the reduction of Glucosyltransferase Enzyme - a Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ipsitha Vejendla 
Designation  PG student 
Affiliation  Saveetha dental college 
Address  Department of conservative dentistry and endodontics, Saveetha dental college and hospital, 162, Poonamallee High Rd, Velappanchavadi, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9515748752  
Fax    
Email  vipsitha1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Krithika Datta 
Designation  Professor, Head of the Department 
Affiliation  Saveetha Dental college and Hospital 
Address  Clinic no.21, Department of cariology, Saveetha dental college and hospital, 162, Poonamallee High Rd, Velappanchavadi, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9840111369  
Fax    
Email  krithikadatta.sdc@saveetha.com  
 
Details of Contact Person
Public Query
 
Name  Ipsitha Vejendla 
Designation  PG student 
Affiliation  Saveetha dental college 
Address  Department of conservative dentistry and endodontics, Saveetha dental college and hospital, 162, Poonamallee High Rd, Velappanchavadi, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9515748752  
Fax    
Email  vipsitha1997@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Dental college and Hospital, 162, Poonamallee high road, Velappanchavadi, Chennai - 600077 
 
Primary Sponsor  
Name  Saveetha Dental college and Hospital 
Address  162, Poonamallee high road, Velappanchavadi, Chennai - 600077 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ipsitha Vejendla  Saveetha Dental college and Hospital  Clinic 21, Department of conservative dentistry and endodontics, 162, Poonamallee high road, Velappanchavadi, Chennai - 600077
Chennai
TAMIL NADU 
9515748752

vipsitha1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha dental college - Institutional Human Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental Caries 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Commercially available fluoridated toothpaste with a fluoride concentration of 1000ppm  A commercially available toothpaste containing fluoride (in 1000ppm concentration) under the brand name, Colgate Strong teeth, will be provided to the participant for toothbrushing for a year. 
Intervention  Commercially available toothpaste containing Salvadora persica (miswak) extract  A commercially available toothpaste containing miswak extract under the brand name, Dabur Meswak, will be provided to the participant for toothbrushing for a year. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  54.00 Year(s)
Gender  Both 
Details  Participants with atleast 1 active carious lesion.
 
 
ExclusionCriteria 
Details  Medically compromised individuals.
Patients with a history of allergic reactions.
Patients undergoing orthodontic treatment. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Glucosyltransferase enzyme absorption index by ELISA  Baseline, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of DMFS status using ICDAS-II scoring  Baseline, 3 months, 6 months, 9 months, 12 months 
Assessment of microbial count in terms of colony forming units  Baseline, 3 months, 6 months, 9 months, 12 months 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Dental caries is a prevalent and widespread oral health problem worldwide. It is a multifactorial disease characterized by the demineralization of tooth enamel and the subsequent formation of cavities. Dental caries is primarily caused by the interaction of several factors, including bacteria, diet, and host susceptibility. To combat dental caries, various preventive strategies have been developed, including regular dental hygiene practices (such as brushing and flossing), dietary modifications (reducing sugar intake), and the use of fluoride-containing products (to strengthen enamel and inhibit acid production). Additionally, efforts have been made to target the enzymatic activity of glucosyltransferase, as inhibiting this enzyme’s function could potentially reduce the formation of dental plaque and mitigate the risk of tooth decay. The study is being conducted to evaluate the effect of two commercially available toothpastes on Glucosyltransferase enzyme activity and their anti-caries effect on teeth.

 
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