| CTRI Number |
CTRI/2025/12/099589 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
20/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Pain Control after Wisdom Tooth Surgery: Comparing Fentanyl Skin Patch and Diclofenac Tablets |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of fentanyl transdermal patch and oral diclofenac sodium for pain management following mandibular third molar surgery: a split-mouth randomised controlled 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 Chanchal Dharia |
| Designation |
PG Student |
| Affiliation |
Terna Dental College and Hospital |
| Address |
Dept no 131, Terna Dental College and hospital, Sector 22, Nerul
Dept no 131, Terna Dental College and hospital, Sector 22, Nerul
Mumbai
MAHARASHTRA
400004
India |
| Phone |
9769200753 |
| Fax |
|
| Email |
chanchalrd51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Joshi |
| Designation |
Professor and HOD |
| Affiliation |
Terna Dental College and Hospital |
| Address |
dept no 131, Terna Dental College, Sector 22, Nerul
dept no 131, Terna Dental College, Sector 22, Nerul
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9869057337 |
| Fax |
|
| Email |
sanjoshi99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chanchal Dharia |
| Designation |
PG Student |
| Affiliation |
Terna Dental College and Hospital |
| Address |
dept no 131, Terna Dental College and hospital, Sector 22, Nerul
dept no 131, Terna Dental College and hospital, Sector 22, Nerul
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9769200753 |
| Fax |
|
| Email |
chanchalrd51@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chanchal Dharia |
| Address |
dept no 131, Terna Dental college and hospital, sector 22, Nerul, Navi Mumbai 400706 |
| Type of Sponsor |
Other [not sponsored] |
|
|
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 Chanchal Dharia |
Terna Dental College and Hospital |
Department no 131, Oral and maxillofacial surgery, Terna Dental College and Hospital, Sector 22, Nerul, Navi Mumbai 400706
Mumbai (Suburban)
MAHARASHTRA |
9769200753
chanchalrd51@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental College Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fentanyl transdermal patch |
Patients requiring bilateral third molar surgery will be given a single 50mcg fentanyl transdermal patch (will be instructed to remove after 72h) and placebo tablet for pain control following the first third molar surgery. Pain will be assessed at 1h, 12h, 24h and 72h, mouth opening and swelling will be assessed at 24h and 72h. |
| Comparator Agent |
Oral diclofenac sodium |
After 10 days, the second third molar surgery will be done under the same conditions. A placebo patch will be administered and single 50mg diclofenac sodium
tablet will be added for pain management for the first 72h. For follow up and pain scores, the same procedure will be followed and readings obtained
will be compared. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients requiring bilateral mandibular third molar surgery
2. Mandibular third molars with mild to moderate difficulty according to Pell
and Gregory difficulty index
3. Patients with ASA I-II physical status |
|
| ExclusionCriteria |
| Details |
1. Patients requiring bilateral mandibular third molar surgery
2. Mandibular third molars with mild to moderate difficulty according to Pell
and Gregory difficulty index
3. Patients with ASA I-II physical status |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score for pain (1-10) |
Postoperatively at 1h, 12h, 24h and 72h |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative swelling will be assessed by a 5-line
measurement using a standard flexible tape. |
preoperatively, then postoperatively at 24h and 72h |
| Maximum mouth opening |
preoperatively, then postoperatively at 24h and 72h |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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="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 - NO
|
|
Brief Summary
|
This study aims to compare the analgesic efficacy of fentanyl transdermal patch and oral diclofenac sodium in managing postoperative pain following bilateral mandibular third molar surgery using a split-mouth randomized controlled design. Twenty patients undergoing bilateral extractions will receive either a fentanyl patch or oral diclofenac sodium postoperatively in two separate sessions. Pain intensity will be assessed using the Visual Analogue Scale (VAS), along with measurements of postoperative swelling and maximum mouth opening. The study will evaluate differences in pain relief, patient recovery, and side-effect profiles between the two modalities to determine the feasibility of using fentanyl patches in acute dental pain management. |