| CTRI Number |
CTRI/2022/05/042412 [Registered on: 09/05/2022] Trial Registered Prospectively |
| Last Modified On: |
06/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of pain killer by different methods after dental treatment |
|
Scientific Title of Study
|
The efficacy of post endodontic pain control using different administration routes for diclofenac sodium in randomized, double-blind, placebo-controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhumika Rathod |
| Designation |
Doctor |
| Affiliation |
College of dental science and research centre |
| Address |
College of dental science and research centre,near silver Alaknanda dental collage road, nr navneet printing , Manipur,Bopal, Gujarat
Ahmadabad
GUJARAT
380058
India |
| Phone |
9727753823 |
| Fax |
|
| Email |
drbhumikapatel2903@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhumika Rathod |
| Designation |
Doctor |
| Affiliation |
College of dental science and research centre |
| Address |
College of dental science and research centre,near silver Alaknanda dental collage road, nr navneet printing , Manipur,Bopal, Gujarat
GUJARAT
380058
India |
| Phone |
9727753823 |
| Fax |
|
| Email |
drbhumikapatel2903@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhumika Rathod |
| Designation |
Doctor |
| Affiliation |
College of dental science and research centre |
| Address |
College of dental science and research centre,near silver Alaknanda dental collage road, nr navneet printing , Manipur,Bopal, Gujarat
GUJARAT
380058
India |
| Phone |
9727753823 |
| Fax |
|
| Email |
drbhumikapatel2903@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Department of COnservative Dentistry and Endodontics College of dental science and research centre,
Near Silver Alaknanda,
Dental College Road, Near Navneet printing, Manipur, Bopal, Ahmedabad; 380058. Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Bhumika Rathod |
| Address |
College of dental science and research centre,
Near Silver Alaknanda,
Dental College Road, Near Navneet printing, Manipur, Bopal, Ahmedabad; 380058. Gujarat |
| 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 Bhumika Rathod |
College of Dental Science and Research Centre |
Room No 7.
Department of Conservative Dentistry and Endodontics,
Ahmadabad
GUJARAT |
9727753823
drbhumikapatel2903@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac Sodium |
Comparing efficacy of different routes of administering diclofenac sodium to control post endodontic pain
Diclofenac Sodium 75mg once given before treatment
transdermal patch applied once before treatment |
| Intervention |
Root Canal Treatment |
Multi-visit endodontic treatment in patients with chronic irreversible pulpitis
Medication given Diclofenac sodium 75 mg orally once before treatment
Transdermal patch applied once before treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Vital pulp in need of endodontic therapy
2. Irreversible pulpitis in molar teeth
3. Age – 18–65 years.
|
|
| ExclusionCriteria |
| Details |
1. History of systemic diseases
2. History of allergy to nonsteroidal anti-inflammatory drugs (NSAIDs)
3. Radiographic evidence of periapical pathosis
4. Pregnant or lactating mothers.
5. Patient must not have taken any pain killer before 24 hours
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-endodontic pain control will be observed by both routes of administration for diclofenac sodium |
6hrs, 12 hrs, 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efficacy of oral route of administration of diclofenac sodium compared to transdermal patch for controlling post endodontic pain at different time interval. |
6hr, 12hr, 24hr, 48hr and 7 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 2 |
|
Date of First Enrollment (India)
|
09/05/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Topic: The efficacy of post endodontic pain
control using different administration routes for diclofenac sodium in a randomized,
double-blind, placebo-controlled study
Introduction:
Experience of root canal-associated
pain is a major source of fear for patients and a very important concern for
dentists. Anxiety, apprehension, fear of dental treatment, and other factors
influence patients’ pain perception and reaction thresholds. Management of
endodontic pain is one of the challenging aspects of endodontics.
Aim and Objective:
The purpose of this clinical trial is to evaluate the analgesic efficacy of
diclofenac sodium administered through oral and transdermal routes in reducing post-endodontic
pain.
Materials and Methods:
Forty-five patients were randomly allocated into three groups. Group A – diclofenac
sodium tablets, Group B – diclofenac sodium (transdermal patch), and Group C –placebo
(Vitamin B12). The tablets were given 30 min before the procedure. The visual analog
scale (VAS) was used to evaluate the pain score at preoperative and 6, 12, 24, 48
h and 7 days after biomechanical
preparation.
Keywords: Diclofenac
sodium; Endodontic treatment; Interappointment pain; Transdermal patch; Oral
tablet |