| 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
|
|
|
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
|
|
|
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. |