| CTRI Number |
CTRI/2023/08/056259 [Registered on: 08/08/2023] Trial Registered Prospectively |
| Last Modified On: |
06/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To examine the effect of single oral dose of ketorolac, dexamethasone, tramadol hydrochloride on frequency and severity of pain following root canal treatment |
|
Scientific Title of Study
|
Comparative Evaluation of the Effect of Oral Premedication with a Single Dose of Ketorolac, Dexamethasone and Tramadol Hydrochloride on the Incidence and Intensity of Post Operative Endodontic Pain: A Double Blinded Randomized Controlled 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 |
Nimisha Jain |
| Designation |
Post Graduate Student |
| Affiliation |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE,SGT UNIVERSITY |
| Address |
SGT UNIVERSITY,GURGAON BADLI ROAD CHANDU BUDHERA, GURUGRAM, HARYANA 122505.
Gurgaon
HARYANA
122505
India |
| Phone |
7497075504 |
| Fax |
|
| Email |
drnimishajain517@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Singla |
| Designation |
Professor |
| Affiliation |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE,SGT UNIVERSITY |
| Address |
SGT UNIVERSITY,GURGAON BADLI ROAD CHANDU BUDHERA, GURUGRAM, HARYANA 122505.
Gurgaon
HARYANA
122505
India |
| Phone |
9891381349 |
| Fax |
|
| Email |
mamta.singla@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Singla |
| Designation |
Professor |
| Affiliation |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE,SGT UNIVERSITY |
| Address |
SGT UNIVERSITY,GURGAON BADLI ROAD CHANDU BUDHERA, GURUGRAM, HARYANA 122505.
Gurgaon
HARYANA
122505
India |
| Phone |
09891381349 |
| Fax |
|
| Email |
mamta.singla@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| SGT Dental College, Hospital and Research Institute, Gurugram, Haryana-122505 |
|
|
Primary Sponsor
|
| Name |
SGT UNIVERSITY |
| Address |
Department of Conservative Dentistry and Endodontics, SGT Dental College, Hospital and Research Institute, Gurugram, Haryana-122505 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 NIMISHA JAIN |
SGT UNIVERSITY |
ROOM NO 5, Department of Conservative Dentistry and Endodontics, SGT Dental College, Hospital and Research Institute, Gurugram, Haryana-122505
Gurgaon
HARYANA |
7497075504
drnimishajain517@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGT UNIVERSITY ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketorolac, Dexamethasone and tramadol hydrochloride |
Ketorolac, Dexamethasone and tramadol hydrochloride will be given in three groups to evaluate intensity and incidence of post operative pain following single sitting root canal treatment. |
| Comparator Agent |
Placebo |
Placebo will be given in one group to evaluate intensity and incidence of post operative pain following single sitting root canal treatment |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1-Mature permanent mandibular posteriors with symptomatic irreversible pulpitis.
2-Teeth having sufficient tooth structure for adequate isolation.
3-No history of previous endodontic therapy.
4-No history of trauma to the involved tooth.
|
|
| ExclusionCriteria |
| Details |
• Patients who have a positive history of analgesic intake within past 3 days.
• Patients with periapical lesion.
• Patients who have a positive history of antibiotics intake in the last month.
• Periodontally compromised teeth.
• Patients with known history of allergy to the drugs in study.
• Diabetic, immunocompromised patients, pregnant, lactating females.
• Calcified roots.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence & intensity of post endodontic pain. |
4 hours,8 hours,12hours,24 hours, 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need & amount of rescue medication for the control of post operative pain |
4 hours,8 hours,12hours,24 hours, 48 hours |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 4 |
|
Date of First Enrollment (India)
|
19/08/2023 |
| 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="6"
Days="0" |
|
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
|
After the clinical examination and diagnosis of symptomatic irreversible pulpitis patients will be divided into four groups by random sequencing. Procedure will be explained to the patients and informed consent will be taken from the patients. Patients will be given drugs by the operator unaware of the drug coding and patient unaware of the drug composition 1 hour prior to the treatment. Single visit root canal treatment will be performed by the operator and pain history on HP-VAS scale along wiith rescue drug requirement and intake at 4 hours, 8 hours, 12 hours,24 hours,48 hours interval following the first visit. |