| CTRI Number |
CTRI/2025/12/098732 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Diclofenac Patches and Tablets for Pain Relief After Dental and Implant Procedures |
|
Scientific Title of Study
|
Comparative evaluation of transdermal and oral diclofenac for postoperative pain management in periodontal and implant surgeries- A Randomized Clinical 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 Anushka G Jain |
| Designation |
Post Graduate Student |
| Affiliation |
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College,Sakri Road,Dhule |
| Address |
Department Of Periodontology, Room Number 03,Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College,Sakri Road,Dhule
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College,Sakri Road,Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
9892935866 |
| Fax |
|
| Email |
jain1311anu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Bhatsange |
| Designation |
Professor |
| Affiliation |
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College,Sakri Road,Dhule |
| Address |
Department Of Periodontology, Room Number 03,Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College,Sakri Road,Dhule
Department Of Periodontology, Room Number 03,Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College,Sakri Road,Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
9960881275 |
| Fax |
|
| Email |
anujaps219@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Bhatsange |
| Designation |
Professor |
| Affiliation |
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College,Sakri Road,Dhule |
| Address |
Department Of Periodontology, Room Number 03,Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College,Sakri Road,Dhule
Department Of Periodontology, Room Number 03,Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College,Sakri Road,Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
9960881275 |
| Fax |
|
| Email |
anujaps219@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Periodontology, Room Number 03,Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College,Sakri Road,Dhule |
|
|
Primary Sponsor
|
| Name |
Dr Anushka G Jain |
| Address |
Department Of Periodontology, Room Number 03,Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College,Sakri Road,Dhule |
| 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 Anushka G Jain |
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College,Sakri Road,Dhule |
Department Of Periodontology, Room Number 03,Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College,Sakri Road,Dhule
Dhule
MAHARASHTRA |
9892935866
jain1311anu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACPM Dental College Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac Oral Tablets 100mg |
After obtaining informed written consent and detailed case history from the patients, the patient will undergo phase-I therapy. After phase-I therapy, the patient will undergo the surgical procedure as required. After the surgery, the patients will receive oral diclofenac tablets twice daily for three days.The patients would be advised to assess the pain perception at 2,4,8 and 12 hours by himself using the VAS Assessment form given to the patient. The patient will be explained about this self-assessment prior to the surgical procedure. Patient would be called for a follow up to the institute at 24, 48 and 72 hours respectively. The pain perception by the patient would be analyzed using parameters like the Visual Analogue Scale, Numeric Rating Scale and Wong Baker Faces pain rating scale. |
| Intervention |
Diclofenac Transdermal Patches 100mg |
After obtaining informed written consent and detailed case history from the patients, the patient will undergo phase-I therapy. After phase-I therapy, the patient will undergo the surgical procedure as required. After the surgery, the transdermal patch will be placed on the arm of the patient .As the duration of action of one patch is of about 24 hours; the patient will be advised to change the transdermal patch after 24 and 48 hours respectively. The patients would be advised to assess the pain perception at 2,4,8 and 12 hours by himself using the VAS Assessment form given to the patient. The patient will be explained about this self-assessment prior to the surgical procedure.
Patient would be called for a follow up to the institute at 24, 48 and 72 hours respectively. The pain perception by the patient would be analyzed using parameters like the Visual Analogue Scale, Numeric Rating Scale and Wong Baker Faces pain rating scale.
Diclofenac Transdermal Patch will be placed for 3 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy individuals
Patient undergoing any major periodontal surgical procedure [ranging from 45- 90 mins]
Patient undergoing implant surgeries/Implant second stage surgery
Patients willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients having gastritis/peptic ulcer.
Patients with known hypersensitivity to the medications
Patients on long term medications.
Pregnant or lactating women.
Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post-Operative Pain Intensity Measurement Using Vas Scale
Analgesic Efficacy Of Oral Diclofenac Tablets And Diclofenac Transdermal Patch
|
At Baseline , 24hours, 48 Hours and 72 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidenceof Adverse Effects Like Gastric Irritation
Patient Satisfaction Score
Local Tissue Reaction At Transdermal Patch Apllication Site
|
At Baseline, 24 hours, 48 hours & 72 hours |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/12/2025 |
| 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="1"
Days="1" |
|
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
|
This is a randomized controlled clinical trial that compares and evaluates the difference in post operative pain control after periodontal and implant surgeries using diclofenac transdermal patches with oral diclofenac tablets of the same potency of 100mg.The primary hypothesis is there is a difference in transdermal patch and oral diclofenac for postoperative pain management in periodontal and implant surgeries. The outcomes will be measured using various scales like Visual Analogue scale, Numeric rating scale and Von bakers faces pain rating scale. The patient will be evaluated at 24, 48 and 72 hours post operatively. |