| CTRI Number |
CTRI/2024/05/067533 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of Gingival Retraction Techniques: Clinical and Patient Outcomes |
|
Scientific Title of Study
|
Assessment of Gingival displacement and patient outcomes with different gingival retraction techniques :A cross-over clinical 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 |
Dr Pooja Nilesh Singh |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental College and Hospitals |
| Address |
Department of Prosthodontics, Clinic 24, 4th Floor, Saveetha dental College and Hospitals, Mount Poonamallee High Road, Velapanchavadi, Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
08369690620 |
| Fax |
|
| Email |
syncpooja1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Nilesh Singh |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental College and Hospitals |
| Address |
Department of Prosthodontics, Clinic 24, 4th Floor, Saveetha dental College and Hospitals, Mount Poonamallee High Road, Velapanchavadi, Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
08369690620 |
| Fax |
|
| Email |
syncpooja1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrutha Shenoy |
| Designation |
Senior Lecturer |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Prosthodontics, Clinic 24, 4th Floor, Saveetha dental College and Hospitals, Mount Poonamallee High Road, Velapanchavadi, Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9819122808 |
| Fax |
|
| Email |
dramruthashenoy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College
162, Mount Poonamallee High road, Velapanchavadi
Tiruvallur
Chennai- 600077
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College |
| Address |
162, Mount Poonamallee High road, Velapanchavadi
Tiruvallur
Chennai- 600077
Tamil Nadu
India |
| 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 |
| Dr Pooja Singh |
Saveetha Dental College |
Clinic 24, Department of Prosthodontics
162, Mount Poonamallee High road, Velapanchavadi
Tiruvallur
Chennai- 600077
Tamil Nadu
India
Thiruvallur
TAMIL NADU |
8369690620
syncpooja1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College-Institutional Human Ethical Committee(SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
chemical retraction for 5 mins |
chemical retraction using astringent retraction paste for 5 mins |
| Intervention |
mechanical gingival retraction for 5 mins |
mechanical gingival retraction with retraction cord for 5 mins |
| Comparator Agent |
no retraction for 5 mins |
no retraction, impression without gingival retraction for 5 mins |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
The inclusion criteria for this study include individuals aged between 20 and 35 years who are systemically healthy and in need of single crowns. Additionally, participants should have a gingival index score of 0, a plaque index score of 0, no periodontal pockets, and negative bleeding on probing. |
|
| ExclusionCriteria |
| Details |
the exclusion criteria encompass periodontally compromised teeth, individuals who are pregnant or lactating, those with a history of systemic diseases or other debilitating conditions, individuals on steroids,, anticoagulants, aspirin, , or other drugs, patients with harmful oral habits, and those unwilling to give consent for the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| gingival displacement, Visual Analogue Scale Scores |
baseline, 7th day and 27th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
27/05/2024 |
| 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="0"
Months="3"
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
|
The Journal of Prosthetic Dentistry is a monthly peer-reviewed medical journal covering prosthodontics and restorative dentistry. it is published by Elsevier on behalf of the Editorial Council for the Journal of Prosthetic Dentistry and the editor-in-chief is Stephen F. Rosentiel |