FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/081947 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 26/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effect of root canal therapy and regrowth therapy for healing of infection 
Scientific Title of Study   Comparative Evaluation of Regenerative endodontic procedure and conventional non-surgical endodontic procedure for treatment of necrosed mature permanent teeth with apical periodontitis - A Randomized Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashlesha Nageshwar Madankar 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  117,department of conservative dentistry and endodontics,govt dental college and hospital,medical square,medical chowk Nagpur,Maharastra,India Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  09637531050  
Fax    
Email  madankarashlesha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sulabha Radke 
Designation  Associate Professor 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  117,department of conservative dentistry and endodontics,govt dental college and hospital,medical square,medical chowk Nagpur,Maharastra,India Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9823262628  
Fax    
Email  sulabharadke@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sulabha Radke 
Designation  Associate Professor 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  117,department of conservative dentistry and endodontics,govt dental college and hospital,medical square,medical chowk Nagpur,Maharastra,India Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9823262628  
Fax    
Email  sulabharadke@gmail.com  
 
Source of Monetary or Material Support  
Government dental college and hospital, medical square,medical chowk,nagpur,maharastra,440003 
 
Primary Sponsor  
Name  Dr. Ashlesha Madankar 
Address  Department of Conservative Dentistry and Endodontics,Government Dental College and Hospital, Nagpur 
Type of Sponsor  Other [self sponsored] 
 
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 Ashlesha Madankar  Government Dental College and Hospital  Room 117, Department of conservative dentistry and endodontics
Nagpur
MAHARASHTRA 
09637531050

madankarashlesha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethics committee,government dental college and hospital,nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional non-surgical endodontic procedure  Conventional root canal obturation technique using gutta percha for treatment of necrosed mature permanent teeth 
Intervention  Regenerative endodontic Procedure  Regenerative endodontic Procedure for treatment of necrosed mature permanent teeth in which blood clot will be induced in the patient after administering local anesthesia followed by placement of collagen plug and biodentin as obturating material in coronal third of root followed by composite resin restoration 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with Permanent single rooted teeth with complete root formation are included. Permanent single rooted teeth with diagnosis of mature necrosed teeth with symptomatic apical periodontitis and Permanent single rooted teeth indicated for primary root canal treatment with Periapical Index Score (PAI) of equal to or more than 3 are included
 
 
ExclusionCriteria 
Details  Patients who are medically compromised are excluded.Patients who had taken antibiotics in last 1 month and Pregnant and lactating women are excluded.Immature teeth or teeth with root resorption and Teeth with calcified canals and Patients with generalized chronic periodontitis and Teeth with previous root canal treatment and Teeth with canal curvature more than 25 degree and Periodontal pocket larger than 3 mm are excluded
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in Periapical Index Score radiographically  1,3,6 and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
CLINICAL EVALUATION (Presence of vitality, swelling, sinus tract with spontaneous, palpation or percussion pain)  1,3,6 and 12 months  
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   10/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/03/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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  

Pulp regeneration continues to receive increasing research attention. Regenerative endodontic procedures (REPs) have been associated with revascularization procedures originally proposed more than 50 years ago. Effective sealing at both the apical and coronal ends of a disinfected root canal system are the essential requisites of a successful root canal treatment. Gutta-percha along with a sealer has been the material of choice for obturating the root canals. The periapex contains a variety of progenitor cells which may participate in the regeneration of tissues as a response to injury. Thus, regeneration rather than replacement of tissues with an artificial substitute is the alternative direction in which endodontics is progressing. Biodentine was developed as a new class of dental material, introduced in 2010 by Gilles and Olivier which could conciliate high mechanical properties with excellent biocompatibility, as well as a bioactive behavior. Biodentine is a new tricalcium silicate (Ca3SiO5) based inorganic restorative commercial cement and advertised as ‘bioactive dentine substitute’. The material is claimed to possess better physical and biological properties compared to other tricalcium silicate cements such as mineral trioxide aggregate (MTA) and Bioaggregate(Bioaggregate).  It is used for crown and root dentin repair treatment, repair of perforations or resorptions, apexification, root-end fillings and as permanent dentine substitute in large carious lesions. 

   Thus, this study compares the non-obturating regenerative endodontic procedure using biodentine and modified triple antibiotic paste with conventional non-surgical gutta percha obturation procedure for the treatment of necrosed mature permanent teeth with apical periodontitis. 
Close