| CTRI Number |
CTRI/2023/06/054214 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
16/06/2023 |
| 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
|
PAIN CONTROL FOLLOWING THE ADMINISTRATION OF DICLOFENAC SODIUM BY TRANSBUCCAL PATCH VERSUS THE CONVENTIONAL PERORAL ROUTE AFTER ROUTINE DENTAL EXTRACTIONS. |
|
Scientific Title of Study
|
EVALUATION OF PAIN CONTROL FOLLOWING THE ADMINISTRATION OF DICLOFENAC SODIUM BY TRANSBUCCAL PATCH VERSUS THE CONVENTIONAL PERORAL ROUTE AFTER ROUTINE DENTAL EXTRACTIONS. A COMPARATIVE SPLIT MOUTH PROSPECTIVE 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 |
Anandrai Kamath |
| Designation |
Post Graduate student |
| Affiliation |
Terna dental college |
| Address |
Room 131, Department of Oral Surgery, Terna Dental College, Nrul West, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
7977167033 |
| Fax |
|
| Email |
anandraikamath11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay Joshi |
| Designation |
Professor and Head of Department |
| Affiliation |
Terna dental college |
| Address |
Room 131, Department of Oral Surgery, Terna Dental College, Nrul West, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9869057337 |
| Fax |
|
| Email |
sanjoshi99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay Joshi |
| Designation |
professor and head of department |
| Affiliation |
Terna dental college |
| Address |
Room 131, Department of Oral Surgery, Terna Dental College, Nerul west, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9869057337 |
| Fax |
|
| Email |
sanjoshi99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room 131, Department of Oral Surgery, Terna Dental College, Nerul west, Navi Mumbai. |
|
|
Primary Sponsor
|
| Name |
terna dental college |
| Address |
Room 131, Department of Oral Surgery, Terna Dental College, Nerul west, Navi Mumbai. |
| 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 |
| Anandrai Kamath |
Terna dental college |
Terna dental college, room 131, department of oral surgery, nerul west, navi mumbai
Thane
MAHARASHTRA |
7977167033
anandraikamath11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| terna dental college ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY, WITH NO COMORBIDITIES |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tablet diclofenac sodium 50mg |
Diclofenac sodium 50mg, is to be administered post-extraction of the concerned tooth, three times a day for 3 days. |
| Intervention |
Transbuccal diclofenac sodium patch 20mg |
Transbuccal diclofenac sodium patch 20mg, to be administered post extraction of the concerned tooth, three times a day for 3 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients aged between 18 to 65 years
b) Without any systemic disease or drug allergy
c) Patients indicated for posterior tooth extraction classified with similar difficulty index.
d) Interval between two extractions appointments should be at least a minimum of 7 days. |
|
| ExclusionCriteria |
| Details |
a) Smokers (current or former)
b) Alcoholics or narcotic abusers.
c) Condition of pregnancy or lactation.
d) Medically compromised patients.
e) Tooth with different difficulty index.
f) Tooth with any grade of mobility or periodontally compromised tooth.
g) Patients with the pathology associated with respect to their tooth indicated for extraction
h) Patients not to be on any opioid analgesics and/or NSAIDs except diclofenac sodium. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PAIN RELIEF |
Pain is to be checked on the VAS scale after every 24 hours for 3 days post-extraction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check the efficacy of the patch in comparison to the conventional peroral route . |
1 year |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/07/2023 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anandraikamath11@gmail.com].
- For how long will this data be available start date provided 20-06-2023 and end date provided 31-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - none
|
|
Brief Summary
|
Patients undergoing bilateral extractions are a standardized model to evaluate acute oral pain post-treatment, as they act as self-control with cross-over trials. Post tooth extraction to control pain and edema non-steroidal anti-inflammatory drugs are generally given. NSAIDs work well to control mild to moderate pain after tooth extraction. However, due to first-pass metabolism, only about 50% of the absorbed diclofenac becomes systemically accessible when administered through the oral route. Furthermore, due to the elevated plasma concentration attained, oral diclofenac also carries the probability of significant adverse reactions, particularly in the gastrointestinal tract. There always exists an alternate route to everything. Likewise, it’s applicable here also. The transbuccal route of administration of drugs is a novel way to deliver the drug directly to the site of our choice, bypassing the hepatic way of metabolism. The transbuccal route of drug administration and incorporating it with diclofenac sodium gives contributing effects of sustained drug delivery, lower plasma concentration, and greater effects at the site with less drug dosage. However, the question of efficiency still exists. The purpose of this study is to compare the efficacy of a transbuccal diclofenac sodium patch (TBDP) with oral diclofenac sodium for pain relief following extractions |
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