| 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
|
|
|
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
|
|
|
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. |