| CTRI Number |
CTRI/2024/06/069695 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| 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
|
Patch up pain without the pills: Transdermal solutions for an effective pain relief: A Randomized Controlled Clinical Trial |
|
Scientific Title of Study
|
Beyond Pills Transdermal patch efficacy in post operative pain relief. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ZUBEIDA HALEEM |
| Designation |
Post Graduate student |
| Affiliation |
A.M.ES Dental College and Hospital Raichur. |
| Address |
A.M.ES Dental College and Hospital Raichur.
Department of periodontics and oral implantology , room 6 ,1st floor .
Raichur
KARNATAKA
584103
India |
| Phone |
7338417875 |
| Fax |
|
| Email |
uroosahaleem@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Nagappa Guttiganur |
| Designation |
principal and H.O.D |
| Affiliation |
A.M.ES Dental College Hospital and Research Center |
| Address |
A.M.ES Dental College Hospital and Research Center
Raichur.
Department of periodontics and oral implantology. room 6 .
Raichur
KARNATAKA
584103
India |
| Phone |
7338417875 |
| Fax |
|
| Email |
nagunags@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
ZUBEIDA HALEEM |
| Designation |
Post Graduate student |
| Affiliation |
A.M.ES Dental College and Hospital Raichur. |
| Address |
A.M.ES Dental College and Hospital Raichur.
Department of periodontics and oral implantology room - 06.
Raichur
KARNATAKA
584103
India |
| Phone |
7338417875 |
| Fax |
|
| Email |
uroosahaleem@gmail.com |
|
|
Source of Monetary or Material Support
|
| Academy of Medical Educations Dental college and Hospital, near Govt. Polytechnic college Raichur - 584103. INDIA. |
|
|
Primary Sponsor
|
| Name |
Academy of Medical Education dental college and hospital |
| Address |
Near government polytechnic college , Raichur - 584103 |
| 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 SHIVANAND ASPALLI |
Academy of Medical Educations Dental College and Hospital |
department of periodontics and oral implantology. room 6 floor 1
Raichur
KARNATAKA |
9886000809
drsaspalli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE ACADEMY OF MEDICAL EDUCATIONs DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
100mg Diclofenac tablet. (voveran SR) |
100mg Diclofenac tablet will be given to patient immediately post periodontal flap surgery for pain relief. |
| Intervention |
transdermal 100mg diclofenac patch.(Nu Patch - Zydus-Cadilla labs) |
transdermal 100mg diclofenac patch will be placed on patients arm immediately post periodontal flap surgery for pain relief. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
(1) having good general health, (2) having at least 6 teeth per quadrant, (3) Patients requiring NSAIDs after periodontal flap surgical procedure. |
|
| ExclusionCriteria |
| Details |
were (1) Subjects with history of allergy to NSAIDs (2) Subjects undergoing treatment with other NSAIDs or any other analgesics or corticosteroids during the trial period and those with history of systemic diseases like bronchial asthma, epilepsy, and emotional and psychosomatic disorders were also excluded (3) Pregnant and lactating females were also excluded (4) H/O drinking or/and smoking. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain reduction post surgery will be evaluated |
pain reduction at 6HRS AND 12HRS
post periodontal flap surgery will be evaluated |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCED GASTRIC IRRITATION due to use of transdermal diclofenac |
6 HOURS AND 12 HOURS post periodontal flap surgery |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| Date of Study Completion (India) |
02/08/2024 |
| 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)
Modification(s)
|
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
|
Abstract: Aim: Assessing the comparative effectiveness of oral diclofenac v/s transdermal diclofenac in patients following periodontal flap surgery. Methodology: 40 Systemically healthy patients of age 25-50yrs including both sexes requiring periodontal flap surgical procedure were selected.100mg diclofenac sodium SR either orally or transdermally was administered 30mins following the surgery. Pain relief and pain intensity with both the diclofenac formulations was recorded at 0, 6th and 12 hour interval using 5-point Verbal Pain Intensity, Pain Relief Score Charts and visual analogue scale. |