| CTRI Number |
CTRI/2025/12/099960 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
does transdermal buprenorphine patch provide pain relief following surgical third molar extraction? |
|
Scientific Title of Study
|
Evaluation of analgesic efficacy of transdermal buprenorphine patch following surgical third molar extraction- a prospective clinical 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 Aditya Jape |
| Designation |
Post Graduate student |
| Affiliation |
Dr D Y Patil Dental College and Hospital Pimpri Pune |
| Address |
Plot number 38 Shivaji Nagar Cement Road Nagpur
Pune
MAHARASHTRA
440010
India |
| Phone |
9823177404 |
| Fax |
|
| Email |
adjape@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Londhe |
| Designation |
Post Graduate student |
| Affiliation |
Dr D Y Patil Dental College and Hospital Pimpri Pune |
| Address |
sant tukaram nagar pimpri pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9637467689 |
| Fax |
|
| Email |
uday.londhe@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditya Jape |
| Designation |
Post Graduate student |
| Affiliation |
Dr D Y Patil Dental College and Hospital Pimpri Pune |
| Address |
Plot number 38 Shivaji Nagar Cement Road Nagpur
Pune
MAHARASHTRA
440010
India |
| Phone |
9823177404 |
| Fax |
|
| Email |
adjape@gmail.com |
|
|
Source of Monetary or Material Support
|
| DOPD 9 Dept of Oral and Maxillofacial Surgery Dr DY Patil Dental College and Hospital Dr DY Patil vidyapeeth Pimpri pune 411018 maharashtra india |
|
|
Primary Sponsor
|
| Name |
DOPD Dept of Oral and Maxillofacial Surgery |
| Address |
DOPD 9 Dept of Oral and Maxillofacial Surgery Dr DY Patil Dental College and Hospital Dr DY Patil vidyapeeth Pimpri pune 411018 maharashtra india |
| Type of Sponsor |
Private medical college |
|
|
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 Aditya Jape |
Dr DY Patil Dental college and Hospital Pimpri Pune |
DOPD 9 Dept of Oral and Maxillofacial Surgery Dr DY Patil Dental College and Hospital Dr DY Patil vidyapeeth Pimpri pune
Pune
MAHARASHTRA |
09823177404
adjape@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Subcommittee Dr DY 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 |
Buprenorphine patch |
Buprenorphine patch to be given and need for rescue medication to be checked along with analgesic efficacy of patch via VAS scale 50mcg patch to be given once after extraction for period of 2 days |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18- 50 years of age.
2. No systemic co morbidities.
3. Indicated for surgical extraction of a third molar.
4. Patients who have not have been administered painkillers prior to the procedure.
5. Patients willing to consent and participate in this study.
|
|
| ExclusionCriteria |
| Details |
1. Patients below the ages of 18 and above 50.
2. Systemic co morbidities.
3. Pregnant/ Lactating women.
4. Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Buprenorphine is expected to provide greater relief from pain , owing to its longer duration of action and ceiling effect.
|
1,12,24 and 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
nil |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/01/2026 |
| 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="4"
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
|
Transdermal drug delivery system such as patches is a non invasive method to deliver drugs through the dermis. This may be a substitute to administration of painkillers through tablet form. |