FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
jcd dental college sirsa 
 
Primary Sponsor  
Name  jcd dental college 
Address  JCD Dental college Barnala road sirsa 
Type of Sponsor  Other [private dental college] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 
 
Close