| CTRI Number |
CTRI/2025/01/079519 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluate the astringency and gingival retraction efficacy among two different concentrations of Triphala - a clinical trial |
|
Scientific Title of Study
|
Comparative evaluation of astringency and gingival retraction efficacy among two different concentrations of Triphala and Aluminium chloride - an invivo study (split mouth design) |
| Trial Acronym |
AETT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sswedheni S U |
| Designation |
Post graduate student |
| Affiliation |
Tagore Dental college and Hospital |
| Address |
Department of Conservative dentistry and Endodontics
Tagore Dental College and Hospital,
Rathinamangalam, Melakkottaiyur Post, Near Vandalur
Chennai
Chennai
TAMIL NADU
600127
India |
| Phone |
91-9003059929 |
| Fax |
|
| Email |
sswedheni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Balagopal |
| Designation |
Head of the department |
| Affiliation |
Tagore Dental college and Hospital |
| Address |
Department of Conservative dentistry and Endodontics
Tagore Dental College and Hospital,
Rathinamangalam, Melakkottaiyur Post, Near Vandalur
Chennai
Chennai
TAMIL NADU
600127
India |
| Phone |
91-9444039411 |
| Fax |
|
| Email |
sbalagopal@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anisha Sebatni M |
| Designation |
Reader |
| Affiliation |
Tagore Dental college and Hospital |
| Address |
Department of Conservative dentistry and Endodontics
Tagore Dental College and Hospital,
Rathinamangalam, Melakkottaiyur Post, Near Vandalur
Chennai
Chennai
TAMIL NADU
600127
India |
| Phone |
91-8344866709 |
| Fax |
|
| Email |
sebatnianisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tagore Dental college and Hospital |
|
|
Primary Sponsor
|
| Name |
Tagore Dental College and Hospital |
| Address |
Department of Conservative dentistry and Endodontics, 3rd floor, Tagore Dental College and Hospital,
Rathinamangalam, Melakkottaiyur Post, Near Vandalur
Chennai- 600127
|
| 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 |
| Sswedheni S U |
Tagore dental college and hospital |
Department of Conservative Dentistry & Endodontics, 3rd floor, Tagore dental college and Hospital, Rathinamangalam, Melakkottaiyur Post, Near Vandalur
Chennai- 600127
Chennai
TAMIL NADU |
9003059929
sswedheni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gingival displacement |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aluminium chloride |
25% Aluminium chloride |
| Intervention |
Triphala |
6% and 10% Triphala |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically and radiographically healthy periodontium and tooth
2.Probing depth 1-2 mm
3.No bleeding on probing
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival retraction efficacy |
Gingival retraction efficacy after 6 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
20/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is to evaluate the astringency and gingival retraction efficacy among two different concentrations of Triphala and 25% Aluminium chloride. The method is to pack gingival retraction cord impregnated with respective solutions into gingival sulcus of molar of three quadrants, wait for 5 min and to make upper and lower putty impressions. Die stone cast will be poured and the model will be analyzed under 20X stereomicroscope at three regions mesiobuccal, mid buccal and distobuccal. |