| CTRI Number |
CTRI/2026/02/103996 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the success of three dental materials i.e calcium hydroxide, calcium silicate, and resin-modified calcium silicate used to protect tooth decay in back teeth: a clinical study. |
|
Scientific Title of Study
|
Comparative evaluation of success rate of calcium hydroxide, calcium silicate, and resin modified calcium silicate for indirect pulp capping in permanent molars: a 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 |
Dr Jayish Singh |
| Designation |
Post graduate student |
| Affiliation |
J.N Kapoor DAV(c) Dental college |
| Address |
Department of conservative dentistry and endodontics. Room no 3.
Model town, yamunanagar. haryana. 135001
Yamunanagar
HARYANA
135001
India |
| Phone |
9915087485 |
| Fax |
|
| Email |
simarskochhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Bogra |
| Designation |
Professor and head of department |
| Affiliation |
J.N Kapoor DAV(c) Dental college |
| Address |
Department of conservative dentistry and endodontics. Room no 3.
Model town, yamunanagar. haryana. 135001
Yamunanagar
HARYANA
135001
India |
| Phone |
9050462962 |
| Fax |
|
| Email |
poonambogra@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayish Singh |
| Designation |
Post graduate student |
| Affiliation |
J.N Kapoor DAV(c) Dental college |
| Address |
Department of conservative dentistry and endodontics. Room no 3.
Model town, yamunanagar. haryana. 135001
Yamunanagar
HARYANA
135001
India |
| Phone |
9915087485 |
| Fax |
|
| Email |
simarskochhar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
J.N Kapoor Dav Dental College Yamunanagar |
| Address |
J.N Kapoor Dav Dental College, Model town Yamunanagar, Haryana
135001 |
| Type of Sponsor |
Other [Private dental 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 Jayish Singh |
J.N Kapoor Dav Dental College Yamunanagar |
Department of conservative dentistry and endodontics. Room no 3.
Yamunanagar
HARYANA |
9915087485
simarskochhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| J.N Kapoor Dav Dental College |
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 |
| Intervention |
Biodentine |
Septodont |
| Intervention |
Dycal |
Dentsply |
| Comparator Agent |
Success rate of dycal, biodentine and theracal lc |
Success rate of dycal (dentsply), Biodentine (septodont), theracal lc ( Bisco) at 3 months, 6 months, 12 months.
total duration of 1.5 year |
| Intervention |
TheraCal LC |
Bisco |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group of 18-40 years
2. Healthy patients with ASA I and ASA II.
3. Permanent molars with extremely deep caries penetrating the entire thickness of dentin and diagnosed with reversible pulpitis.
4. Teeth that can be easily restored with composite resin.
|
|
| ExclusionCriteria |
| Details |
1. Patients with permanent molars diagnosed with irreversible pulpitis or pulp necrosis.
2. Teeth exhibiting tenderness on percussion, sinus tract, mobility, furcation, PDL widening, or periapical radiolucency.
3. Teeth that are not conducive to rubber dam application.
4. Pregnant and lactating mothers.
5. Patients who are hypersensitive to NSAIDS and antibiotics.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical assessment of pain, swelling, vitality test and pathologic mobility along with radiographic assessment of periradicular architecture and root resorption |
3 months, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain |
24hours, 48 hours and 7 days |
|
|
Target Sample Size
|
Total Sample Size="110"
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 2 |
|
Date of First Enrollment (India)
|
26/02/2026 |
| 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="6"
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
|
RESEARCH QUESTION
1. What is the success outcome of Indirect Pulp Capping with Calcium Hydroxide in permanent molars with extremely deep caries diagnosed with reversible pulpitis. 2. What is the success outcome of Indirect Pulp Capping with Calcium Silicate in permanent molars with extremely deep caries diagnosed with reversible pulpitis. 3. What is the success outcome of Indirect Pulp Capping with Resin modified Calcium Silicate in permanent molars with extremely deep caries diagnosed with reversible pulpitis.
Aim: The aim of this randomized clinical trial will be to evaluate and compare the success rate of Calcium Hydroxide, Calcium Silicate, And Resin Modified Calcium Silicate as Indirect pulp capping agents in patients with extremely deep caries in permanent molars diagnosed with reversible pulpitis.
Objectives: 1. To evaluate the success of Calcium Hydroxide as an indirect pulp capping material in permanent molars with extremely deep carious lesions diagnosed with reversible pulpitis. 2. To evaluate the success of Calcium Silicate as an indirect pulp capping material in permanent molars with extremely deep carious lesions diagnosed with reversible pulpitis. 3. To evaluate the success of Resin Modified Calcium Silicate as an indirect pulp capping material in permanent molars with extremely deep carious lesions diagnosed with reversible pulpitis. 4. To statistically evaluate and compare success of Calcium Hydroxide, Calcium Silicate, And Resin Modified Calcium Silicate as indirect pulp capping materials in permanent molars with extremely deep carious lesions diagnosed with reversible pulpitis.
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