| CTRI Number |
CTRI/2025/08/092611 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating how effective chitosan-based wound dressings are for gum enlargement surgeries |
|
Scientific Title of Study
|
EVALUATION OF THE EFFECTIVENESS OF CHITOSAN-BASED DRESSING ON WOUND HEALING BY SECONDARY INTENTION: AN IN VIVO STUDY |
| 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 Shivi Mittal |
| Designation |
Postgraduate student |
| Affiliation |
|
| Address |
Room no.3, Department of Periodontology,Kothiwal Dental College and Research Centre, Mora Mustaqueem,Kanth Road
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9711775454 |
| Fax |
|
| Email |
shivimittal5678@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ellora Madan |
| Designation |
Junior Resident 1 |
| Affiliation |
|
| Address |
Kothiwal Dental College and Research Centre,Haridwar Road, Mora Mustaqueem,Kanth Road
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
|
| Fax |
|
| Email |
ellorabhattmadan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivi Mittal |
| Designation |
|
| Affiliation |
|
| Address |
Room no.3, Department of Periodontology,Kothiwal Dental College and Research Centre,Mora Mustaqueem,Kanth Road
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
|
| Fax |
|
| Email |
shivimittal5678@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kothiwal Dental College and Research Centre |
| Address |
Kothiwal Dental College and Research Centre,Haridwar Road, Mohra Ki Milak, Moradabad, Uttar Pradesh 244001 |
| 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 Shivi Mittal |
Kothiwal Dental College and Research Centre |
Room No. 3, Department of Periodontology, Moradabad, Uttar Pradesh
Moradabad
UTTAR PRADESH |
09711775454
shivimittal5678@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with Gingival Enlargement |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chitosan based dressing along with Coe-Pak post gingivectomy
|
Chitosan based dressing is sourced from R2 Healthcare, New Delhi in standard size (5cmx5cm).Duration 45 minutes |
| Intervention |
Eugenol free periodontal dressing (Coe-Pak) after Gingivectomy |
Procured from the Department of Periodontology,Kothiwal Dental College and Research Centre.Duration 45 minutes |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects requiring excisional gingival procedures undergoing healing by secondary intention.
2. Subjects with gingival enlargement Grade greater or equal to 2 involving at least 3 teeth on each side of the midline in an arch.
3. Subjects who gave written informed consent |
|
| ExclusionCriteria |
| Details |
1. Subjects taking any medication which can influence the gingival response during healing
2. Subjects with any systemic disease affecting the periodontium
3. Pregnant women, lactating mothers, postmenopausal women
4. Subjects with any blood dyscrasia or bleeding disorder
5. Smokers and tobacco chewers
6. Subjects who were unable to perform routine oral hygiene procedures or not complying with oral hygiene instructions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of Pain on 1st, 3rd and 7th day respectively
2. Assessment of Healing on 7th, 15th and 30th day respectively |
1. Assessment of Pain on 1st, 3rd and 7th day respectively
2. Assessment of Healing on 7th, 15th and 30th day respectively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the results in both the groups that is control group coepak alone & test group chitosan based dressing with coepak after 2 years |
To compare the results in both the groups that is control group coepak alone & test group chitosan based dressing with coepak after 2 years |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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 4 |
|
Date of First Enrollment (India)
|
17/08/2025 |
| 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="0"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shivimittal5678@gmail.com].
- For how long will this data be available start date provided 10-10-2025 and end date provided 12-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This in vivo randomized controlled trial evaluates the effectiveness of chitosan-based dressing (AXIOSTAT) on gingival wound healing by secondary intention following gingivectomy. A total of 26 systemically healthy patients requiring excisional gingival procedures will be selected and randomly allocated into two groups. Group A (control) will receive Coe-Pak periodontal dressing alone, while Group B (test) will receive chitosan dressing with Coe-Pak. Pain will be assessed using the Visual Analogue Scale (VAS) on days 1, 3, and 7. Healing will be evaluated using the Landry Healing Index on days 7, 15, and 30. The study will follow a single-blinded design to reduce bias.
Chitosan is a natural biopolymer derived from chitin with excellent biocompatibility, antimicrobial properties, and hemostatic potential. Its sponge form promotes clot stabilization, enhances tissue regeneration, and offers improved healing in open wounds. This study aims to compare its efficacy with conventional periodontal dressings in terms of pain reduction and accelerated healing. Ethical clearance and CTRI registration will be obtained. The findings of this study may help establish chitosan as a superior biomaterial for post-surgical wound management in periodontology, improving patient comfort and clinical outcomes during healing by secondary intention. |