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CTRI Number  CTRI/2024/10/074776 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pain after root canal treatment with different techniques.  
Scientific Title of Study   Evaluation of post-obturation pain after using different obturation techniques in patients undergoing root canal treatment- a randomized controlled 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  Kavalipurapu Venkata Teja  
Designation  Assistant Professor  
Affiliation  Saveetha Dental College  
Address  Saveetha Dental College Poonamale high road Chennai Tamilnadu

Chennai
TAMIL NADU
600077
India 
Phone  9751933999  
Fax    
Email  metejaendo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kavalipurapu Venkata Teja  
Designation  Assistant Professor  
Affiliation  Saveetha Dental College  
Address  Saveetha Dental College Poonamale high road Chennai Tamilnadu

Chennai
TAMIL NADU
600077
India 
Phone  9751933999  
Fax    
Email  metejaendo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kavalipurapu Venkata Teja  
Designation  Assistant Professor  
Affiliation  Saveetha Dental College  
Address  Saveetha Dental College Poonamale high road Chennai Tamilnadu

Chennai
TAMIL NADU
600077
India 
Phone  9751933999  
Fax    
Email  metejaendo@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Dental College & Hospitals, Chennai, Tamil Nadu, India.  
 
Primary Sponsor  
Name  Kavalipurapu Venkata Teja 
Address  Saveetha Dental College & hospitals, Poonamalle high road, Vellapanchavadi, Chennai, TamilNadu, India Pin code: 600077 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Kavalipurapu Venkata Teja   Saveetha Dental College   Chennai, TamilNadu, India
Chennai
TAMIL NADU 
9751933999

metejaendo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Symptomatic irreversible pulpitis  
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cold lateral compaction   the patients in this group underwent root canal obturation using lateral condensation. Here after root canal preparation, cleaning and drying, thr master cone was confirmed with x-ray. followed by sequential accessory cones placed and lateral compactions given using a spreader. finally, the gutta-percha was cut and the access cavity was sealed.  
Intervention  Continous wave compaction   after the complete root canal shaping, cleaning and drying, the patients in this group underwent obturation after placing matched taper cone in canal, which is confirmed with an x-ray. After specific confirmation, the gutta-percha was warm vertically compacted and the rest of the canal was backfilled with thermoplastic gutta-percha. the orifice was then selaed with composite.  
Intervention  Modifed heat technique   After the root canal shaping, cleaning and drying, the patients in this group underwent obturation using matched single cone. however, the temperature for shearing the gutta-percha and warm vertical condensations was set to 120-degree Celsius using a electric heated plugger. after warm vertical condensations, the orifice of access was sealed using composite.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants included were between the age group of 18 to 60, who requires endodontic therapy for molars and premolars that were diagnosed as symptomatic irreversible pulpitis. 
 
ExclusionCriteria 
Details  Participants who were medically compromised, pregnant woman, antibiotic therapy, teeth with incomplete apex formation, calcified canals, periapical abscess, and sinus opening were excluded for the study. 
 
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 
Postoperative pain   12 and 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Nil   Nil  
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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 3 
Date of First Enrollment (India)   12/10/2024 
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="1"
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  

This study will adopt a prospective, single centered, randomized controlled clinical trial method to meet the objectives. Participants included will be between the age group of 18 to 60, who requires endodontic therapy for molars and premolars that were diagnosed as symptomatic/asymptomatic irreversible pulpitis with apical periodontitis. Participants who were medically compromised, pregnant woman, antibiotic therapy, teeth with incomplete apex formation, calcified canals, periapical abscess, and sinus opening will be excluded for the study.

The study participants will be recruited from the pool of patients in the Department of Conservative Dentistry and Endodontics at Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Chennai, India. The sample size estimation was calculated using a priori by G-power (3.0.10). The minimum sample size of each group was calculated, following these input conditions. The total sample size obtained was 57 samples with 19 samples per group. In order to compensate the drop out, sample size was kept at 63 (21 samples per group).

Block randomizationwill be  done well in advance by a third person who was not related to the study using block of  9, of which number 2, 4, 5 assigned to Group I –Cold Lateral Compaction, number 1, 3, 7 to Group II – Modifed heat technique, and number 6, 8, 9 to Group III –Continuous Wave Compaction. SNOSE (sequentially numbered, opaque, sealed envelopes) method will be implemented for allocation concealment which conceals the sequence until interventions were assigned. A piece of paper containing randomized group number will be sealed in the dark coloured envelope containing respective serial number over it prepared by a third person. The group is mentioned clearly and sealed in the envelope. Patients will be assigned their study numbers as they sequentially entered the study. The envelope was opened once the intervention was assigned. Based on the group assigned in the paper, respective treatment was carried out.

 
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