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CTRI Number  CTRI/2020/02/023603 [Registered on: 26/02/2020] Trial Registered Prospectively
Last Modified On: 15/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Long term evaluation of success and survival Of Immature Permanent Teeth Treated with Different treatment Protocols 
Scientific Title of Study   Clinical, CBCT Based Radiographic assessment and Biomechanical analysis Of Immature Permanent Teeth Treated with Different Regenerative Protocols: A multi arm Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Sangeeta Talwar  
Designation  Director-Principal  
Affiliation  Maulana Azad Institute of Dental Sciences, New Delhi 
Address  Third Floor, Department of Conservative Dentistry & Endodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi- 110002,

Central
DELHI
110002
India 
Phone  9654700950  
Fax    
Email  sangeeta.talwar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ruchika Roongta Nawal 
Designation  Associate Professor 
Affiliation  Maulana Azad Institute of Dental Sciences, New Delhi 
Address  Third Floor, Department of Conservative Dentistry & Endodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi- 110002,

Central
DELHI
110002
India 
Phone  9582948894  
Fax    
Email  ruchika.roongta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sudha Yadav  
Designation  Senior Research Associate 
Affiliation  Maulana Azad Institute of Dental Sciences, New Delhi 
Address  Room no 302, Third Floor, Department of Conservative Dentistry & Endodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi- 110002,

Central
DELHI
110002
India 
Phone  8010629600  
Fax    
Email  sudhayadav2788@gmail.com  
 
Source of Monetary or Material Support  
Council of Scientific & Industrial Research (CSIR), India 
 
Primary Sponsor  
Name  maulana Azad Institute of Dental Sciences 
Address  Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi- 110002 
Type of Sponsor  Government medical 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 
Dr Sangeeta Talwar  Maulana Azad Institute of dental sciences  Room no 302, Third Floor, Department of Conservative Dentistry & Endodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi- 110002,
Central
DELHI 
9654700950

sangeeta.talwar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAIDS ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  MTA Apexification  Apexification will be performed using Mineral Trioxide aggregate (MTA). 4-5 mm MTA will be compacted in the apical third of the root canal using hand pluggers. 
Intervention  Regenerative endodontic treatment with blood clot  Bleeding will be induced in the root canal by over instrumenting with a #25 file and allowed to reach 3–4 mm below the cementoenamel junction. After blood clot formation, mineral trioxide aggregate will be placed over blood clot at cervical level.  
Intervention  Regenerative endodontic treatment with injectable Platelet rich fibrin  10 mL blood will be collected in a sterile polyethylene terephthalate plastic tubes without anticoagulant which will be immediately centrifuged at 700 rpm for 3 minutes to abtain injectable platelet rich fibrin (iPRF). The iPRF sample will be placed into the canal space to a level 3 mm below the cementoenamel junction (CEJ) using sterile 27-G needle tips.mineral trioxide aggregate will be placed over it at cervical level 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Immature necrotic permanent teeth showing clinical and radiographic diagnosis of pulp necrosis with or without periapical involvement
2. Radiographically the tooth has an open apex (> 1mm)
3. Age of the patient: 13-30 years
 
 
ExclusionCriteria 
Details  1. Medical conditions that would contraindicate endodontic treatment (eg, acute systemic disease and abnormalities in host defense),
2. Remaining crown/root structure with questionable restorability
3. Teeth with vertical fractures
4. Periodontally involved teeth
5. Lack of patient and parent cooperation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
the resolution of clinical symptoms and the evidence of osseous healing on CBCT evaluation  6,12,18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Increase in root wall thickness, increase in root length and decrease in apical diameter on CBCT evaluation  6,12,18 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="41" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/03/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

The conventional treatment modality (Apexification) for the management of immature teeth doesn’t allow for any increase in root dimensions of immature teeth. To overcome this problem regenerative treatment has gained popularity in recent years. Regenerative endodontic treatment (RET) promotes increase in root length/width which might have a positive influence on the stress pattern in immature teeth. RET commonly use provoked apical bleeding into the canal space for creating a blood clot. Recently, injectable platelet rich fibrin has shown promising regenerative efficacy. Hence, this randomized controlled trial will be conducted on patients presenting with necrotic immature teeth with incomplete root development to compare these treatment modalities. We hypothesize that there will be no significant difference in the clinical success and radiographic root development among the three groups. Following the inclusion and exclusion criteria, 60 patients will be enrolled for the study and they will be randomly divided into 3 equal groups of 20 each ( group 1, group 2, group 3).  Group 1 will be treated with MTA Apexification, Group 2: Regenerative endodontic treatment with blood clot, Group 3: Regenerative endodontic treatment supplemented with injectable platelet rich fibrin. The patients will be recalled after 6, 12, 18 months for clinical and radiographic follow up. Pre operative and final postoperative (18 months) Cone beam computed tomography (CBCT) images will be imported into image analyzing software. Thereafter changes in root dimensions between the preoperative and final postoperative images will be evaluated by measuring the changes in root length, dentin wall thickness and apical foramen width. The clinical success, survival, radiographic root development will be evaluated and compared amongst three groups. In addition, Stress distribution pattern will be analyzed using cone beam computed tomography based finite model analysis.

 
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