| CTRI Number |
CTRI/2025/06/089893 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Indirect Pulp Capping Using Two Bioactive Materials. |
|
Scientific Title of Study
|
Evaluation of Indirect pulp capping using Two Bioactive Materials MTA and Theracal PT : A Randomised Control Trial using Cone-Beam Computed Tomography |
| Trial Acronym |
MTA-TPT Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chaya Chhabra |
| Designation |
Professor and Head of the department |
| Affiliation |
NIMS Dental college and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry,NIMS Dental college and Hospital,NIMS University ,B S Tomar City ,Shobha Nagar,Jaipur-Delhi Highway ,Jaipur ,Rajasthan -303121
INDIA
Jaipur
RAJASTHAN
303121
India |
| Phone |
9929535666 |
| Fax |
|
| Email |
chaya.chhabra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Angha Uday Patil |
| Designation |
Postgraduate |
| Affiliation |
NIMS Dental college and Hospital |
| Address |
NIMS Dental college and Hospital,NIMS University ,B S Tomar City ,Shobha Nagar,Jaipur-Delhi Highway ,Jaipur ,Rajasthan,room no 7,
303121,
INDIA
Jaipur
RAJASTHAN
303121
India |
| Phone |
7039095000 |
| Fax |
|
| Email |
anghap24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Angha Uday Patil |
| Designation |
Postgraduate |
| Affiliation |
NIMS Dental college and Hospital |
| Address |
NIMS Dental college and Hospital,NIMS University ,B S Tomar City ,Shobha Nagar,Jaipur-Delhi Highway ,Jaipur ,Rajasthan,room no 7,
303121,
INDIA
Jaipur
RAJASTHAN
303121
India |
| Phone |
7039095000 |
| Fax |
|
| Email |
anghap24@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIMS Dental college and Hospital,NIMS University,Jaipur ,Rajasthan -303121 |
|
|
Primary Sponsor
|
| Name |
Dr Angha Uday Patil |
| Address |
Camellia Girls Hostel 503,NIMS Dental college and Hospital,NIMS University ,B S Tomar City ,Shobha Nagar,Jaipur-Delhi Highway ,Jaipur ,Rajasthan -303121 |
| Type of Sponsor |
Other [self funded] |
|
|
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 Chaya Chhabra |
NIMS Dental College and Hospital |
Poatgraduate Clinic Department no 7, NIMS Dental college and Hospital,NIMS University ,B S Tomar City ,Shobha Nagar,Jaipur-Delhi Highway ,Jaipur ,Rajasthan -303121
Jaipur
RAJASTHAN |
9929535666
chaya.chhabra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children aged 7-12 yrs without systemic issues, able to maintain oral hygiene, follow protocol, with cooperative, accepting parents or caregivers. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mineral Trioxide Aggregate (MTA) |
Mineral Trioxide Aggregate (MTA) will be placed within the cavity after removal of infected dentin and will be compared with TheraCal PT as materials then the remaining dentine thickness and dentine bridge formation after 6 months |
| Intervention |
TheraCal PT |
TheraCal PT will be placed within the cavity after removal of infected dentine and used as indirect pulp capping material then after 6 months remaining dentin thickness and dentine bridge formation will be checked |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Teeth affected with deep caries on occlusal and proximal surfaces experiencing mild reversible pain and mild discomfort while chewing.
Teeth showing radiographic evidence of caries extending beyond two third of dentin thickness approaching pulp. |
|
| ExclusionCriteria |
| Details |
Children with systemic health issues, those on medications, or children with Special needs or Uncooperative behavior were excluded.
Teeth showing signs of irreversible pulpitis such as spontaneous pain, sensitivity to percussion, mobility, sinus formation, abscess, widened periodontal spaces, disrupted lamina dura, pulp exposure or radiographic evidence of periapical or furcational radiolucency were excluded. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of reparative dentin thickness beneath the IPC material using CBCT. |
Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical and radiographic success of the treatment over a follow-up period of 6 months
This would include:
Absence of pain
No tenderness on percussion
No swelling or sinus tract
No periapical/furcal radiolucency
Maintenance of pulp vitality
No internal/external root resorption |
Baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="1"
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
|
This randomized controlled trial aims to evaluate and compare the efficacy of two bioactive materials—Mineral Trioxide Aggregate (MTA) and TheraCal PT—when used for indirect pulp capping (IPC) in primary or permanent teeth. The primary objective is to assess the thickness of reparative dentin formation using Cone-Beam Computed Tomography (CBCT). A secondary objective includes evaluating the clinical and radiographic success of the treatments over a defined follow-up period. The study seeks to determine which material offers superior outcomes in terms of pulp healing and dentin regeneration. |