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
|
|
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
|
|
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. |