| CTRI Number |
CTRI/2026/01/100890 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Evaluate the Effect of a Chitosan-Based Absorbable Sponge in Reducing Pain and Improving Healing in Patients with Dry Socket |
|
Scientific Title of Study
|
Evaluating effectiveness of chitosan-infused absorbable gelatin sponge in managing dry socket - Randomised Control 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 |
Abhilasha Lad |
| Designation |
Resident |
| Affiliation |
DY Patil Dental College and Hospital |
| Address |
Dept of Oral and Maxillofacial Surgery, OPD no 9, Dr. DY Patil Dental College and Hospital, Pimpri Cinchwad, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9960460918 |
| Fax |
|
| Email |
Abhilasha5lad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sonal Shah |
| Designation |
Professor |
| Affiliation |
DY Patil Dental College and Hospital |
| Address |
Dept of Oral and Maxillofacial Surgery, OPD no 9, Dr. DY Patil Dental College and Hospital, Pimpri Cinchwad, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9960460918 |
| Fax |
|
| Email |
Sonal.shah@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Abhilasha Lad |
| Designation |
Resident |
| Affiliation |
DY Patil Dental College and Hospital |
| Address |
Dept of Oral and Maxillofacial Surgery, OPD no 9, Dr. DY Patil Dental College and Hospital, Pimpri Cinchwad, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9960460918 |
| Fax |
|
| Email |
Abhilasha5lad@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Abhilasha Lad |
| Address |
21, Cosmos town, near Netaji hall, Jaitala road, Nagpur. 411018 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Abhilasha Lad |
Dr D.Y Patil Dental College and Hospital |
Dept of Oral and Maxillofacial Surgery, OPD no 9, Pimpri cinchwad, Pune
411018
Pune
MAHARASHTRA |
9960460918
24040041.dental@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee. Dr.D.Y.Patil Vidyapeeth, Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chitosan infused absorbable gelatine sponge |
Chitosan infused absorbable gelatine sponge will be placed in dry socket when patient presents to the department, and follow up will be done on 1st and 3rd post intervention days. |
| Comparator Agent |
Standard absorbable gelatin sponge |
Standard absorbable gelatin sponge will be placed in dry sockets when patient presents to the department, and follow up will be done on 1st and 3rd post intervention days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with dry socket or alveolar osteitis following tooth extraction.
2. Generally healthy individuals without significant systemic diseases that could affect wound healing.
3. Patients who provide informed consent to participate in the study.
4. Patients that have undergone Intra-Alveolar tooth extraction.
|
|
| ExclusionCriteria |
| Details |
1.Patients on anticoagulant therapy or other medications that could interfere with hemostasis or wound healing.
2.Patients with known allergies to chitosan, gelatin, shellfish and other component.
3.Pregnant or breastfeeding women.
4.Patients who are unable or unwilling to comply with the study protocol and follow-up visits.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain will be assessed using Visual analogue scale and healing will be assessed using modified healing scale |
On 4th and 7th post operative day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
30/01/2026 |
| 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="0"
Months="2"
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 - NO
|
|
Brief Summary
|
This is a Double Blind, Randomised Controlled trial, which will check weather use of absorbable gelatin sponges infused with chitosan, compared to standard gelatin sponges, improve pain management and shorten the resolution time of dry socket in patients with alveolar osteitis following intra alveolar extractions, by measuring wound healing and particularly within the fourth and seventh days of treatment.
|