| CTRI Number |
CTRI/2025/04/084935 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of a new biomaterial in oral surgery procedure to reduce pain and improve healing |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of a novel biomaterial in wound healing and postoperative pain management in alveoloplasty. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manoj Bafna |
| Designation |
MDS Trainee |
| Affiliation |
DR D Y Patil Dental College And Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College And Hospital, Sant Tukaram Nagar, pimpri, pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9176317008 |
| Fax |
|
| Email |
bafna7008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kalyani Bhate |
| Designation |
MDS |
| Affiliation |
DR D Y Patil Dental College And Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College And Hospital, Sant Tukaram Nagar, pimpri, pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9822099311 |
| Fax |
|
| Email |
kalyani.bhate@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Manoj Bafna |
| Designation |
MDS Trainee |
| Affiliation |
DR D Y Patil Dental College And Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College And Hospital, Sant Tukaram Nagar, pimpri, pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9176317008 |
| Fax |
|
| Email |
bafna7008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College And Hospital
Sant Tukaram Nagar, Pimpri, Pune, Maharashtra - 411018 |
|
|
Primary Sponsor
|
| Name |
Department of Oral and Maxillofacial Surgery Dr DY Patil Dental College And Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College And Hospital, Sant Tukaram Nagar, pimpri, pune
MAHARASHTRA
411018
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 Kalyani Bhate |
Dr D Y Patil Dental College And Hospital |
Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College And Hospital, Sant Tukaram Nagar, pimpri, pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA |
9822099311
kalyani.bhate@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR D.Y PATIL VIDYAPEETH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers requiring Alveoloplasty |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Novel Biomaterial |
Novel Biomaterial is an intermeshing of chitosan acting as a scaffold impregnated with AgNP and 2% lidocaine that will serve the purpose of wound healing and antibacterial properties along with pain relief for the patient post-operatively |
| Comparator Agent |
Without Novel Biomaterial |
Biomaterial will not be placed on the alveoloplasty site and site will be sutured and compared |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring bilateral alveoloplasty procedure |
|
| ExclusionCriteria |
| Details |
1. Patients with any systemic diseases
2. Patients with known psychological disorder
3. Patients with history of allergy to lignocaine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Wound Healing
2. Pain |
1. Wound Healing -1 week
2. Pain - 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Rescue medications requirement |
1 week |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "14"
Final Enrollment numbers achieved (India)="14" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| Date of Study Completion (India) |
27/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Aim: This study aims to evaluate the efficacy of novel biomaterial in wound healing and postoperative pain management in alveoloplasty. Materials and methods: A non-randomised double-blinded study is designed where 14 patients who required bilateral alveoloplasty were selected for this study. In all patients, an Alveoloplasty procedure will be carried out. In one quadrant, novel biomaterial is placed on the alveoloplasty site, whereas in the other quadrant, novel biomaterial is not placed, and suturing is done on the alveoloplasty site. Post-operative soft tissue wound healing and pain will be evaluated. Result : The collected data will be subjected to statistical analysis with a chi-square test and independent sample t-test. |