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CTRI Number  CTRI/2024/02/062552 [Registered on: 12/02/2024] Trial Registered Prospectively
Last Modified On: 24/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial in testing a new way to treat infected mature teeth. 
Scientific Title of Study   Regenerative endodontic procedures for treatment of necrotic mature teeth with periapical lesions - 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  M S REZVANA BEGUM 
Designation  POST GRADUATE MDS 
Affiliation  Rajah muthiah dental college and hospital 
Address  Department of Conservative Dentistry and Endodontics Rajah Muthiah Dental College And Hospital Cuddalore District Chidambaram

Cuddalore
TAMIL NADU
608002
India 
Phone  9841378615  
Fax    
Email  rezvanathaslim29@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR A SHAFIE AHAMED 
Designation  PROFESSOR AND HEAD  
Affiliation  Rajah muthiah dental college and hospital 
Address  Department of Conservative Dentistry and Endodontics Rajah Muthiah Dental College and Hospital Cuddalore district chidambaram

Cuddalore
TAMIL NADU
608002
India 
Phone  9487442339  
Fax    
Email  speciality2001@gmail.com  
 
Details of Contact Person
Public Query  
Name  M S REZVANA BEGUM 
Designation  POST GRADUATE MDS 
Affiliation  Rajah muthiah dental college and hospital 
Address  Department of Conservative Dentistry and Endodontics Rajah Muthiah Dental College and Hospital Cuddalore district Chidambaram

Cuddalore
TAMIL NADU
608002
India 
Phone  9841378615  
Fax    
Email  rezvanathaslim29@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics Rajah Muthiah Dental College and Hospital Cuddalore District Chidambaram 608002 
 
Primary Sponsor  
Name  REZVANA BEGUM 
Address  Rajah muthiah dental college and hospital 
Type of Sponsor  Other [Self] 
 
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 M S REZVANA BEGUM  Rajah Muthiah Dental College and Hospital   Department of Conservative Dentistry and Endodontics
Cuddalore
TAMIL NADU 		 9841378615

rezvanathaslim29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Member Secretary Institutional Human Ethics Committee Rajah Muthiah Medical College Annamalai University Annamalai Nagar - 608002  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K04||Diseases of pulp and periapical tissues,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  REGENERATIVE ENDODONTIC PROCEDURE WITH BLOOD CLOT  According to AAE First appointment involves infection control and inflammation relief Second appointment pulp regeneration and revascularization will be accomplished First appointment includes anaesthesia and isolation access preparation root canal preparation and irrigation medicated intracanal dressing Second appointment after 2 to 4 weeks cleaning anaesthesia isolation disinfection and temporary seal removal root canal irrigation Regenerative endodontic procedure by inducing bleeding in the canal control group only bleeding will be induced finally access cavity will be restored Total duration 12 months  
Intervention  REGENERATIVE ENDODONTIC PROCEDURE WITH COLLAGEN  According to AAE First appointment involves infection control and inflammation relief Second appointment pulp regeneration and revascularization will be accomplished First appointment includes anaesthesia and isolation access preparation root canal preparation and irrigation medicated intracanal dressing Second appointment after 2 to 4 weeks cleaning anaesthesia isolation disinfection and temporary seal removal root canal irrigation Regenerative endodontic procedure by inducing bleeding in the canal test group bleeding will be induced followed by placement of collagen finally access cavity will be restored Total duration 12 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Nonvital single rooted maxillary anterior tooth with a mature root and a periapical lesion with a periapical index score equal to or more than 3 according to the classification of orstavik et al 1986
Radiologic confirmation of a single rooted necrotic tooth with a single root canal
 
 
ExclusionCriteria 
Details  Teeth with severe coronal defects that require post and core as final restoration
Non-restorable teeth
Presence of other pathological root resorption
Teeth with previous root canal treatment
Presence of periodontitis
Pregnant or lactating females
A history of systemic diseases or any allergies
 
 
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 
The primary outcome is obtained by evaluating the clinical and radiographic outcomes
Success
After REP
the tooth is asymptomatic absence of percussion pain sinus or fistula
The radiographic examination demonstrates the absence or reduced apical shadow
Failure
After REP
the tooth is symptomatic with symptoms of apical infection such as pain and fistula
The radiographic examination demonstrates a new onset apical shadow or an enlarged apical shadow
 		 Baseline 3month 6month 12month 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes include the subjective response from the patient to thermal & electric
stimuli, which reflects the responsiveness of regenerative pulpal sensory neurons.
POSITIVE RESPONSE NORMAL RESPONSE The test tooth is considered normal if
the patient responds similarly to when a control
tooth is tested
NO RESPONSE The tested tooth is considered to have no response if the patient does not
respond to stimulation
 		 Baseline 3month 6month 12month 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   04/03/2024 
Date of Study Completion (India) 31/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rezvanathaslim29@gmail.com].

  6. For how long will this data be available start date provided 06-05-2024 and end date provided 07-05-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

This study is a randomized ,double blind, parallel group,controlled trial

The aim of the present study is to assess the radiographic healing and the possibility of regaining pulp sensibility in mature permanent teeth with necrotic pulps that were treated using two REPs 

REP with blood clot and REP with collagen as scaffold

The primary objective of this study is to compare and evaluate the efficacy of REP using Collagen and blood clots as scaffolds for the treatment of mature permanent teeth with necrotic pulp

 The secondary aim is to assess the factors influencing the clinical outcomes of REP in mature permanent teeth with necrotic pulps

Age of the patient

Apical diameter enlargement 

Disinfection protocols

The primary outcome of this study is the success rate of REP 12 months postoperatively which will be obtained by evaluating the clinical and radiographic outcomes

The secondary outcomes include the subjective response from the patient to thermal and electric stimuli which reflects the responsiveness of regenerative pulpal sensory neurons 


Youssef A, Ali M, ElBolok A, Hassan R. Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial. Int Endod J. 2022 Apr;55(4):334-346

Arslan H, Ahmed HMA, Şahin Y, Doğanay Yıldız E, Gündoğdu EC, Güven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872.


 
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