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CTRI Number  CTRI/2025/03/081708 [Registered on: 05/03/2025] Trial Registered Prospectively
Last Modified On: 05/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical and radiographic comparative evaluation of indirect pulp treatment with dual cured resin modified calcium silicate, MTA and calcium hydroxide in primary molars 
Scientific Title of Study   Clinical and radiographic comparative evaluation of indirect pulp treatment with dual cured resin modified calcium silicate ,MTA, and calcium hydroxide in primary molars:A 12 Months follow up randomised clinical 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  Paresh Pawar 
Designation  Post graduate student 
Affiliation  Pacific Dental College and Hospital, Debari Udaipur-313024 
Address  Pacific Dental College and Hospital, Debari Udaipur-313024 department of paediatric and preventive dentistry room no.9
Pacific Dental College and Hospital, Debari Udaipur-313024 department of paediatric and preventive dentistry room no.9
Udaipur
RAJASTHAN
313024
India 
Phone  8605235383  
Fax    
Email  pareshpawarpedo007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dinesh Rao  
Designation  HOD Pg guide 
Affiliation  Pacific Dental College and Hospital, Debari Udaipur-313024 
Address  Pacific Dental College and Hospital, Debari Udaipur-313024 department of paediatric and preventive dentistry room no.9
Pacific Dental College and Hospital, Debari Udaipur-313024 department of paediatric and preventive dentistry room no.9
Udaipur
RAJASTHAN
313024
India 
Phone  9414158235  
Fax    
Email  pedodinesh2003@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Paresh Pawar 
Designation  Post graduate student 
Affiliation  Pacific Dental College and Hospital, Debari Udaipur-313024 
Address  Pacific Dental College and Hospital, Debari Udaipur-313024 department of paediatric and preventive dentistry room no.9
Pacific Dental College and Hospital, Debari Udaipur-313024 department of paediatric and preventive dentistry room no.9
Udaipur
RAJASTHAN
313024
India 
Phone  08605235383  
Fax    
Email  pareshpawarpedo007@gmail.com  
 
Source of Monetary or Material Support  
CALCIUM HYDROXIDE Dentsply Sirona, Charlotte, North Carolina, United States 28269 
MTA Kids-e-dental LLP Headquarters 411- Akruti Arcade JP road, Azad nagar, Opp A.H. Wadia school, Andheri west,Mumbai, India 400053 
TheraCal PT BISCO Inc 1100 W Irving Park Rd, Schaumburg, IL 60193 U.S.A. · (800) 247-3368  
 
Primary Sponsor  
Name  Paresh Pawar 
Address  Pacific Dental College and Hospital, Debari Udaipur-313024 
Type of Sponsor  Other [Other ] 
 
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 PARESH PAWAR  PACIFIC DENTAL COLLEGE AND HOSPITAL, DEBARI, UDAIPUR  Pacific Dental College and Hospital, Debari Udaipur-313024 department of paediatric and preventive dentistry room no.9
Udaipur
RAJASTHAN 
08605235383

pareshpawarpedo007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee Sai Tirupati University Udaipur Rajasthan India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Calcium hydroxide  Calcium hydroxide is a biocompatible material used in pulp capping. Its considered the gold standard for pulp capping.  
Intervention  Dual cured resin modified calcium silicate  TheraCal PT is a biocompatible, dual-cured, resin-modified calcium silicate designed for pulp capping.At intervals of 3,6,12 months 
Comparator Agent  MTA  MTA putty is a dental material used for a variety of procedures, including pulp capping agent. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Aged 5-10 years
History of tolerable dull intermittent pain
Mild discomfort associated with eating
Negative history of spontaneous extreme pain
On clinical examination large carious lesions involving either the occlusal or proximal surfaces with normal appearances of gingiva
Radiographic examination revealed carious lesion involving more than 2/3rd thickness of dentin
The pulp normal lamina dura normal periodontal ligament space more than 2/3rd of root present no periapical changes no pathologic external or internal resorption should not cause any harm to the succedaneous tooth
 
 
ExclusionCriteria 
Details  •History of sharp, penetrating pulpalgia indicating acute pulpal inflammation and necrosis.
•Prolonged spontaneous pain at night.
•Clinical examination revealed presence of mobility of tooth, discoloration of tooth
•Negative reaction to electric pulp testing, sinus opening, or abscessed tooth.
•Radiographic examination revealed carious lesion producing definite pulp exposure.
•Interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency, internal or external resorption
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Dual cured resin modified calcium silicate(TheraCal PT) and MTA show less operating time compared to Calcium Hydroxide  Evaluation will be done at baseline,3 Months,6 Months and 12 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Dual cured resin modified calcium silicate(TheraCal PT) & MTA show clinical success as compared to Calcium Hydroxide  Evaluation will be done at baseline,3 Months,6 Months And 12 Months 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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 4 
Date of First Enrollment (India)   16/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  16/03/2025 
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 Yet Recruiting 
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  

Children with deep carious lesions and no history of spontaneous pain will undergo standardized periapical and bitewing radiographs. Eligible teeth will be randomly assigned to three groups based on the material used.

During IPT, after topical anesthesia, the tooth will be isolated with a rubber dam. Caries will be removed using a slow-speed handpiece with a round carbide bur. Lateral walls and cavosurface margins will be fully cleaned, while affected dentin at the pulpal floor will be preserved. The cavity will be flushed with saline for 10 seconds and dried with cotton pellets.

For Group I, TheraCal PT will be applied with a syringe, light-cured for 10 seconds, followed by an RMGIC base and composite restoration. In Group II, premixed MTA will be applied with a syringe for 30 seconds, condensed lightly, followed by an RMGIC restoration. In Group III, calcium hydroxide will be mixed in equal parts, applied with ball-ended condensers, followed by an RMGIC restoration.

All cavities will receive RMGIC restoration. A baseline radiograph with a grid will be taken using an XCP holder. Clinical and radiographic evaluations will be performed at 3, 6, and 12 months, assessing pain, percussion tenderness, discoloration, and sinus formation. Radiographs will be scanned and analyzed digitally.

Dentin thickness will be measured using CorelDRAW software. Radiographs will be assessed for root resorption, PDL space widening, periapical radiolucency, dentin formation, and intrapulpal calcifications. Treatment success will require pulp vitality with no spontaneous pain. Radiographic success will require reactionary dentin formation without furcation radiolucency, PDL widening, or root resorption.

 
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