| CTRI Number |
CTRI/2026/03/106887 [Registered on: 25/03/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparision of soft tissue healing of tooth sockets treated with 0.8% hyaluronic acid with normal healing in diabetes mellitus patients |
|
Scientific Title of Study
|
Comparative evaluation of soft tissue healing in extracted tooth socket treated with 0.8 percent Hyaluronic Acid versus control in Type II Diabetes Mellitus-A Randomised 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 Pallavi Shyam Ghodpage |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Guwahati |
| Address |
Department of Dentistry
AIIMS Guwahati
Kamrup
ASSAM
781011
India |
| Phone |
9836205713 |
| Fax |
|
| Email |
pghodpage@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Shyam Ghodpage |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Guwahati |
| Address |
Department of Dentistry
AIIMS Guwahati
Kamrup
ASSAM
781011
India |
| Phone |
9836205713 |
| Fax |
|
| Email |
pghodpage@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Shyam Ghodpage |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Guwahati |
| Address |
Department of Dentistry
AIIMS Guwahati
Kamrup
ASSAM
781011
India |
| Phone |
9836205713 |
| Fax |
|
| Email |
pghodpage@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Pallavi Shyam ghodpage |
| Address |
Department of dentistry
AIIMS Guwahati
silbharal chnagsari,Guwahati, Assam 781101 |
| Type of Sponsor |
Other [Self(Principal investigator)] |
|
|
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 |
| DrPallavi Shyam Ghodpage |
Aiims Guwahati |
Department of dentistry
OPD Building,2nd floor
AIIMS Guwahati
Kamrup
ASSAM |
9836205713
pghodpage@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyaluronic Acid |
After extraction, followed by debridement, a prefilled syringe containing 0.8% hyaluronic acid gel will be loaded in and placed inside the socket and the socket will be sutured. The gel will be left into the socket until it is resorbed
Duration of intervention follow up 21 days |
| Comparator Agent |
standard treatment |
Extraction socket left to heal with out any biomaterial |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged from 35 to 60 years.
2. Patients with controlled Type 2 Diabetes Mellitus(HbA1C below
7%)
3. Patient undergoing atleast 2 atraumatic extractions.
4. Patients willing to participate and for follow up |
|
| ExclusionCriteria |
| Details |
Presence of abscess for the teeth indicated for extraction
2. Patients allergic to Hyaluronic acid
3. Poorly controlled diabetic patient ((HbA1C 8% or higher)
4. Patients with Immunocompromised conditions
5. Patients on anticoagulant and antiplatelet therapy
6. Pregnant/ Lactating women
7. Chronic smokers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Soft-tissue healing score (Landry’s wound healing index)
Measurement: Clinical evaluation + standardised photographs on Day 7,14,21
Standardisation:
Same scoring criteria for all sockets.
|
7th,14th and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Wound area
Method: Measured with vernier caliper.
Pain (VAS score)
Method: Patient marks pain level (0–10) on a visual analogue scale.
Standardisation:
Patients instructed on how to use VAS.
Pain (VAS score)
Method: Patient marks pain level (0–10) on a visual analogue scale.
Standardisation:
Patients instructed on how to use VAS.
|
7th,14th & 21st day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/04/2026 |
| 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="1"
Months="0"
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
|
Healing in Diabetes Mellitus is delayed as compared to healthy patients.The present study evaluates the efficacy of 0.8% hyaluronic acid in enhancing soft tissue healing after tooth extraction in extracted tooth sockets of diabetic patients. |