| CTRI Number |
CTRI/2025/04/084356 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical and radiographic success of ProRoot MTA and E-MTA. |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical and Radiographic Success Rates of Pro-Root MTA with KIDS E MTA as Apexification agent in Permanent immature Incisors and molars |
| Trial Acronym |
MTA study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sourabh Ramesh Joshi |
| Designation |
Professor |
| Affiliation |
Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736 |
| Address |
Department of Pediatric Dentistry, Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
8698636946 |
| Fax |
|
| Email |
sj3040829@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sourabh Ramesh Joshi |
| Designation |
Professor |
| Affiliation |
Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736 |
| Address |
Department of Pediatric Dentistry, Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
8698636946 |
| Fax |
|
| Email |
sj3040829@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sourabh Ramesh Joshi |
| Designation |
Professor |
| Affiliation |
Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736 |
| Address |
Department of Pediatric Dentistry, Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
8698636946 |
| Fax |
|
| Email |
sj3040829@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rural Dental College, Pravara Institute of Medical Sciences, loni-413736 |
|
|
Primary Sponsor
|
| Name |
Sourabh Ramesh Joshi |
| Address |
Dept of Pediatric Dentistry, Rural Dental College, Pravara Institute of Medical Sciences, loni-413736 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sourabh Ramesh Joshi |
Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736 |
Dept of Pediatric Dentistry, Rural Dental College, Pravara Institute of Medical Sciences, loni-413736 Ahmadnagar MAHARASHTRA |
08698636946
sj3040829@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PIMS-DU, Loni |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Total 90 Patients from age group 8-13 years divided in four groups;who have sustained Ellis Class-III or IV fractures in their permanent maxillary incisors and;molars having deep carious lesion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Apexification |
The test groups will be divided into two groups (group 1 & group 2) and will be compared with the control group. So total three groups (2 test groups and 1 control group) will be part of our study. Each group will consist of 30 children. Total sample size will be 90. |
| Intervention |
Intervention will be apexification procedure in 90 patients |
The children will be divided into three main Groups with each group having 30 children in each group. Where Group 1(test) will consist of children having fractured incisors with open apices, Group 2 (test) will consist of children having carious molars with open apices. Group 1 and 2 will be further subdivided into A and B, where subgroup 1A and 2A will be treated with Pro Root MTA and subgroup 1B and 2 B will be treated (15 children in each subgroup) with KIDS e MTA. Group 3 will be a control group where in the apexification procedure with both test materials will be compared with the Calcium hydroxide apexification method. The sample size for the control group will be 30.
Clinical and radiographic assessment of both the groups will be carried out at recall periods of 3, 6, and 9 months postoperatively and clinical features such as pain, tenderness to percussion, swelling/intraoral sinus, along with radiographic parameters like calcific bridge formation, periapical radiolucency (if present at baseline), intra-oral/extra oral root resorption will be evaluated.
The following measurement methods shall be used for evaluation of pain and periapical radiolucency-:
For measuring pain, the Visual Analog Scale (VAS) shall be used, scored from 0 (no pain) to 10 (worst possible pain).
For measuring Periapical radiolucency, the Complex Periapical Index (COPI) shall be used, which is composed of three parameters related to characteristics of periapical lesion.
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Childrens parent willing to give informed consent will be part of the study.
Children between the ages of eight and thirteen years who have sustained Ellis Class-III or IV fractures in their permanent maxillary incisors
Children between the ages of eight and thirteen years who have deep carious lesion with intact tooth walls.
Children having Spontaneous or night pain, intraoral or extraoral swelling as clinical sign and symptom
Apical diameter in the range of 0.8-1.2mm of open apex molars and incisors will be included in the study |
|
| ExclusionCriteria |
| Details |
Cariously mutilated teeth
Teeth with any developmental anomaly
Teeth with external or internal root resorption
Teeth showing fracture line involving or extending up to the roots
Teeth with root caries
Teeth with cervical abrasion
Teeth with severe mobility grade II or more than grade II mobility were excluded
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
No history of post-operative pain or swelling with the treated tooth/teeth
Reduction in mobility of tooth
|
No history of post-operative pain or swelling with the treated tooth/teeth
Reduction in mobility of tooth
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post-operative radiograph showing reduction in size of the radiolucency
No increase in size of radiolucency in post operative radiograph
No PDL widening seen in postoperative radiograph
No external or Internal Resorption seen after Apexification Procedure
|
baseline,3months,6monthsand 9months |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
01/05/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
When a tooth has an open apex due to dental trauma or caries, it becomes challenging to achieve a successful root filling during endodontic treatment. Injuries resulting from trauma are frequently observed during childhood and in toddlers, with a higher susceptibility for upper front teeth to experience fractures. The closing of the root apex occurs approximately three years after tooth eruption. In cases where the apex remains open due to injury, there may be the presence of residual living pulp tissues and some enduring apical papilla cells in the surrounding periapical tissue. Apexification, the preferred non-surgical approach for treating necrotic immature permanent teeth, has seen various materials used over time. Initially, the widely accepted method involved using calcium hydroxide combined with camphorated monochlorophenol to stimulate the development of the apical barrier, as proposed by Kaiser in 1964. Nevertheless, this substance took nearly 5 to 20 months to create the necessary hard tissue barrier. Numerous materials have been developed, assessed, and established to achieve optimal results in advanced clinical performance. Mineral trioxide aggregate (MTA) was pioneered by Mahmoud Torabinejad at Loma Linda University in California, USA. Its introduction to the dental field was initially documented by Lee and colleagues in 1993. Mineral trioxide aggregate (MTA) serves multiple purposes in dentistry, such as functioning as a reparative substance for repairing perforations, as well as being employed in procedures like pulp capping, pulpotomy, creating an apical barrier in cases with open apex, and for retrograde filling. There have been recent developments in the apexification procedure, where MTA serves as a primary solid block. The gap created due to material shrinkage after placement is now filled with apatite-like deposits that form during MTA maturation. This enhances MTA’s ability to resist friction against root canal walls. MTA stands out for its excellent biocompatibility, reduced cytotoxicity due to its alkaline pH, and has garnered significant attention for its superior sealing capabilities, biocompatibility, regenerative potential, and antibacterial properties. Its formulation containing calcium and phosphate ions promotes the attraction of bone-forming cells and creates a favorable environment for cementum deposition. Moreover the cost of 1 gram of Pro-Root MTA (USA) is 10000/- , whereas the cost of 1gram E-MTA is 4000/- which is a more economical option. Considering the affordability of the treatment by the patients and Indian Dentists, it is essential to carry out trials comparing the efficacy of new material with the conventional one. Numerous clinical studies on the use of MTA in apexification can be found in the literature. Limited literature is available comparing E-MTA with Pro Root MTA. The present study aims to evaluate the clinical and radiographic success of E MTA with Pro Root MTA as apexification agents in permanent immature incisors and molars. |