CTRI Number |
CTRI/2021/09/036246 [Registered on: 06/09/2021] Trial Registered Prospectively |
Last Modified On: |
21/02/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Comparison of Different intracanal medicaments in the management of interappointment pain during root canal treatment |
Scientific Title of Study
|
Comparative evaluation of diffrent intracanal medicaments in management of inter appointment endodontic pain |
Trial Acronym |
CURCUMIN |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rakesh Singla |
Designation |
professor and head |
Affiliation |
JCD dental college, Sirsa |
Address |
Department of Conservative Dentistry and Endodontics
JCD Dental College
Barnala Road
Sirsa HARYANA 125055 India |
Phone |
7015852466 |
Fax |
|
Email |
singlaendo@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rakesh Singla |
Designation |
professor and head |
Affiliation |
JCD dental college, Sirsa |
Address |
Department of Conservative Dentistry and Endodontics
JCD Dental College
Barnala Road
Sirsa HARYANA 125055 India |
Phone |
7015852466 |
Fax |
|
Email |
singlaendo@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr CHARU GUPTA |
Designation |
post graduate student |
Affiliation |
JCD dental college, Sirsa |
Address |
Department of Conservative Dentistry and Endodontics
JCD Dental College
Barnala Road
Sirsa HARYANA 125055 India |
Phone |
9466671007 |
Fax |
|
Email |
drcharu84@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
jcd dental college |
Address |
JCD Dental college
Barnala road
sirsa |
Type of Sponsor |
Other [private dental 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 |
DRRakesh Singla |
JCD dental college |
room no 7
dept of conservative dentistry and endodontics
sirsa Sirsa HARYANA |
9466671007
singlaendo@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institiutional ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
cases indicated for root canal treatment |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
calcium hydroxide and triple antibiotic paste as intracanal medicament |
calcium hydroxide and triple antibiotic paste will be mixed with propylene glycol and placed in the root canal for 7 days |
Intervention |
curcumin as intracanal medicament |
CURCUMIN will be mixed with propylene glycol and placed in the root canal for 7 days |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
healthy adults giving consent for root canal treatment
single rooted maxillary and mandibular teeth with diagnosis of symptomatic irreversible pulpitis |
|
ExclusionCriteria |
Details |
1. who did not give consent,
2. allergic to any of the medicaments,
3. suffering from any disease,
4. pregnant or lactating |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
role of Curcumin in managing interappointment endodontic pain |
4 hours, 24 hrs, 48 hrs, 72 hrs,
96 hrs, 120 hrs, 144 hrs, 168 hrs |
|
Secondary Outcome
|
Outcome |
TimePoints |
comparison of curcumin with calcium hydroxide and triple antibiotic paste |
4 hour, 24 hours and then daily after treatment |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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
|
N/A |
Date of First Enrollment (India)
|
10/09/2021 |
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="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
From a patient’s perspective, the primary objective of undergoing root canal treatment is complete relief from pain. Though endodontic therapy eventually relieves pain, it has been reported that upto 80% of population continues to report mild to severe pain after endodontic treatment. The development of pain following endodontic treatment is usually due to acute inflammatory response to microbial/physical/ chemical injury to the peri-radicular tissues Intracanal medication has been widely used in efforts to kill any bacteria remaining after instrumentation and irrigation. By remaining for a longer time in the canal than irrigants, antimicrobial intracanal medicaments have a higher probability to reach microorganisms located in areas unaffected by the chemo-mechanical preparation and thereby help in disinfection of the entire root canal system. Calcium hydroxide and Triple Antibiotic Pastes are common intracanal medicaments used with variable results. No clinical study has evaluated and compared the effect of curcuma longa with these commonly available intracanal medicaments. Therefore, the aim of this study was to comparatively evaluate the effect of Curcuma longa (Turmeric), Calcium hydroxide and Triple Antibiotic Paste as intracanal medicaments on inter-appointment pain in teeth undergoing root canal treatment.
|