FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/098941 [Registered on: 11/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to compare gum retraction around a back tooth using a standard chemical agent and different strengths of a natural Acacia Catechu herbal solution. 
Scientific Title of Study   Evaluation and comparison of gingival retraction by 25% aluminium chloride impregnated retraction cord and 10%, 15% & 20% concentrations of acacia catechu herbal solution impregnated retraction cord on single posterior tooth: 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  Dr Shreya Waikar 
Designation  Post Graduate student 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. 
Address  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India

Nagpur
MAHARASHTRA
441110
India 
Phone  08793964556  
Fax    
Email  tri.swaikar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Girish Kubasad 
Designation  Professor, Head of the department and PG guide 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. 
Address  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India

Nagpur
MAHARASHTRA
441110
India 
Phone  7259405630  
Fax    
Email  dr.girishkubasad@sdk-dentalcollege.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Girish Kubasad 
Designation  Professor, Head of the department and PG guide 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. 
Address  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India

Nagpur
MAHARASHTRA
441110
India 
Phone  7259405630  
Fax    
Email  dr.girishkubasad@sdk-dentalcollege.edu.in  
 
Source of Monetary or Material Support  
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital , Hingna, Nagpur. 
 
Primary Sponsor  
Name  Dr. Shreya Waikar 
Address  Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital , Hingna, Nagpur. 
Type of Sponsor  Other [self] 
 
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 
Dr Shreya Waikar  Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital  104, Department Of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur, Maharashtra
Nagpur
MAHARASHTRA 		 8793964556

tri.swaikar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee- Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  volunteers with healthy gingiva 
Patients  (1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  25% aluminium chloride impregnated retraction cord  25% aluminium chloride impregnated retraction cord will be used for gingival retraction 
Intervention  10% concentration of acacia catechu herbal solution impregnated retraction cord  10% concentration of acacia catechu herbal solution impregnated retraction cord will be used for gingival retraction 
Intervention  15% concentration of acacia catechu herbal solution impregnated retraction cord  15% concentration of acacia catechu herbal solution impregnated retraction cord will be used for gingival retraction 
Intervention  20% concentration of acacia catechu herbal solution impregnated retraction cord  20% concentration of acacia catechu herbal solution impregnated retraction cord will be used for gingival retraction 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with healthy gingiva.
Volunteer patients who agree to give written informed consent will be considered as individuals for the research.
 
 
ExclusionCriteria 
Details  Patients having gingivitis or periodontitis
Patients undergoing orthodontic treatment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate gingival retraction using 25% aluminium chloride impregnated cord on a single posterior tooth.
To evaluate and compare gingival retraction using 10% Acacia catechu cord with 25% aluminium chloride cord.
To evaluate and compare gingival retraction using 15% Acacia catechu cord with 25% aluminium chloride cord.
To evaluate and compare gingival retraction using 20% Acacia catechu cord with 25% aluminium chloride cord. 		 at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To compare 10%, 15% & 20% concentrations of Acacia catechu herbal solution in achieving gingival retraction on single posterior tooth  at baseline 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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   N/A 
Date of First Enrollment (India)   01/01/2026 
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="2"
Months="2"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Gingival retraction is a crucial step in fixed prosthodontic procedures to accurately record finish lines and ensure the longevity of restorations. Conventional chemical agents such as aluminium chloride, though effective, may have undesirable effects on gingival tissues and impression materials. Acacia catechu, a medicinal plant known for its astringent, antibacterial, and anti-inflammatory properties, offers potential as a biocompatible alternative.

This single-blind, randomized controlled clinical trial will include 16 participants. Each participant will undergo gingival retraction on a single posterior tooth using four different retraction cords impregnated with 25% aluminium chloride and Acacia catechu solutions of 10%, 15%, and 20% concentrations, applied at 7-day intervals. The degree of gingival displacement will be measured under an optical microscope using image analysis software.

Data will be statistically analyzed using one-way ANOVA and post-hoc tests to determine significant differences among groups. The study seeks to identify the most effective concentration of Acacia catechu solution for gingival retraction compared with the conventional aluminium chloride method, thereby exploring a safer, natural, and cost-effective alternative for clinical use in prosthodontics.

 
Close