| CTRI Number |
CTRI/2025/08/093503 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To compare Ketoprofen and Diclofenac patches for pain control after periodontal flap surgery |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of ketoprofen and diclofenac transdermal patch in the management of postoperative pain following periodontal flap surgery - A Split mouth, Randomized Controlled 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 |
Jaswanth sanam G |
| Designation |
PG student |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room no 11 Dept of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
7337884737 |
| Fax |
|
| Email |
drjaswanthsanamg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Pai G |
| Designation |
Professor |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room no 11 Dept of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9845156405 |
| Fax |
|
| Email |
prakashpaipai2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaswanth sanam G |
| Designation |
PG student |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room no 11 Dept of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
7337884737 |
| Fax |
|
| Email |
drjaswanthsanamg@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327 |
|
|
Primary Sponsor
|
| Name |
Jaswanth sanam G |
| Address |
Room no 11 Dept of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327 |
| 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 |
| Jaswanth sanam G |
KVG Dental College and Hospital |
Room no 11 Dept of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA |
7337884737
drjaswanthsanamg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Dental College and Hospital |
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 Diethylamine patch(Dicloplast patch, 100mg) for 3days |
1)Patients included under the study will be divided into two groups, Group A and Group B.
2)All the surgeries will be performed by the same clinician
3)Local anaesthesia using lidocaine 2% epinephrine 1:80000 will be administered prior to surgery.
4)Flap surgery will be performed after thorough scaling and root planing.
5)Sutures will be placed with 3-0 black silk sutures after performing periodontal flap surgery
6)Postoperative instructions will be explained and given in written format to the subjects
7)Antibiotics will be prescribed
8)Based on the randomization, Patients of Group A and Group B will be given prescribed medications.
9)Group A- Patients will be prescribed a Ketoprofen patch(Ketoplast plus patch, 30mg) after completion of surgery.
10)Group B- Patients will be prescribed a Diclofenac Diethylamine patch(Dicloplast patch, 100mg) after completion of surgery.
11)Patients will be given pain assessment chart using the pain scale to evaluate the postoperative pain after the flap surgery as measured at hourly intervals from 1 to 8 hours on day of surgery
12)Patients will be recalled after one week post flap surgery for follow up and suture removal.
13)The patients will be recalled one week postoperatively for suture removal and pain score chart will be evaluated.
14)The rescue medication tablets taken, if any, will be noted, and the patients will be asked if they experienced any adverse effects(if any) such as gastric discomfort, nausea, vomiting, gastric acidity or burning sensation, dyspepsia, diarrhoea, dizziness and pruritus.
15)The patients satisfaction and preference of Diclofenac and ketoprofen transdermal patch will be noted.
|
| Intervention |
Ketoprofen patch(Ketoplast plus patch, 30mg) for 3days |
1)Patients included under the study will be divided into two groups, Group A and Group B.
2)All the surgeries will be performed by the same clinician
3)Local anaesthesia using lidocaine 2% epinephrine 1:80000 will be administered prior to surgery.
4)Flap surgery will be performed after thorough scaling and root planing.
5)Sutures will be placed with 3-0 black silk sutures after performing periodontal flap surgery
6)Postoperative instructions will be explained and given in written format to the subjects
7)Antibiotics will be prescribed
8)Based on the randomization, Patients of Group A and Group B will be given prescribed medications.
9)Group A- Patients will be prescribed a Ketoprofen patch(Ketoplast plus patch, 30mg) after completion of surgery.
10)Group B- Patients will be prescribed a Diclofenac Diethylamine patch(Dicloplast patch, 100mg) after completion of surgery.
11)Patients will be given pain assessment chart using the pain scale to evaluate the postoperative pain after the flap surgery as measured at hourly intervals from 1 to 8 hours on day of surgery
12)Patients will be recalled after one week post flap surgery for follow up and suture removal.
13)The patients will be recalled one week postoperatively for suture removal and pain score chart will be evaluated.
14)The rescue medication tablets taken, if any, will be noted, and the patients will be asked if they experienced any adverse effects(if any) such as gastric discomfort, nausea, vomiting, gastric acidity or burning sensation, dyspepsia, diarrhoea, dizziness and pruritus.
15)The patients satisfaction and preference of Diclofenac and ketoprofen transdermal patch will be noted.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Systemically healthy patient.
2)Patient age ranging 25-60 years.
3)Periodontal pocket depth more than or equal to 5mm.
4)Patient requiring at least 2 quadrants for flap surgery.
5)Patients with good oral hygiene after scaling and root planning.
6)Presence of at least 20 natural teeth.
7)Patient willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1)The patients who are undergoing treatment with analgesics or corticosteroids during the trial period.
2)Pregnancy and lactating mothers.
Smokers and alcoholic.
3)Patients with cardiovascular disease.
4)Patients with gastrointestinal bleeding or ulcers.
5)Patients with liver diseases.
6)Patients with kidney diseases.
7)Patient allergic to Diclofenac and Ketoprofen.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the efficacy of Ketoprofen and Diclofenac transdermal patch in the management of postoperative pain following periodontal flap surgery. |
Every hour upto 8hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To evaluate the efficacy of Diclofenac transdermal patch in reducing postoperative pain following periodontology flap surgery.
2)To evaluate the efficacy of Ketoprofen transdermal patch in reducing postoperative pain following periodontology flap surgery.
3)To compare the efficacy of Ketoprofen and Diclofenac transdermal patch in reducing postoperative pain following periodontal flap surgery.
4)To evaluate the adverse reaction (if any) following the use of Diclofenac and Ketoprofen transdermal patch.
|
Every hour upto 8hours |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
07/11/2025 |
| 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="6"
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
|
Periodontal diseases are inflammatory disorders that cause progressive bone loss and eventually loss of teeth and supporting structures. Periodontal surgery aims to eliminate causative agents to arrest inflammation, but successful treatment also requires proper control of postoperative pain, which is one of the most common complications. Effective pain management is essential for patient comfort and compliance.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for pain control in dentistry. Commonly prescribed agents include paracetamol, aspirin, diclofenac sodium, ketoprofen, and ibuprofen. These drugs are administered through various routes such as oral, parenteral, nasal, or transdermal. However, oral administration has limitations—mainly first-pass metabolism, which reduces drug bioavailability to nearly 50%, and difficulties in patients with physical or mental disabilities.
Transdermal drug delivery offers several advantages over oral administration. It bypasses first-pass metabolism, allows sustained and controlled absorption, maintains stable plasma concentration, avoids gastrointestinal discomfort, and enables simple discontinuation by removing the patch. This system has recently gained popularity as it can deliver drugs either locally to adjacent tissues or systemically via the circulation.
Transdermal patches, or medicated adhesive skin patches, provide a convenient, non-invasive method of drug administration. They ensure controlled drug release, minimize fluctuations in plasma levels, and reduce side effects commonly associated with oral therapy. Ketoprofen, an aryl-propionic acid derivative, acts by non-selective inhibition of COX-1 and COX-2 enzymes, reducing prostaglandin synthesis and producing analgesic and anti-inflammatory effects. Diclofenac, an aryl-acetic acid derivative, shows relative selectivity for COX-2 inhibition, also suppressing prostaglandin production and providing similar benefits. Both drugs have proven oral efficacy, and their formulation as transdermal patches may enhance analgesic effectiveness with fewer systemic drawbacks.
This study focuses on evaluating ketoprofen and diclofenac in transdermal delivery systems for postoperative pain management in periodontal surgery, reflecting the evolving role of skin-based drug administration in dentistry and its promising future applications. |