| CTRI Number |
CTRI/2025/07/090409 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of Four Calcium-Based Agents in Indirect Pulp Capping: An In Vivo Comparison
|
|
Scientific Title of Study
|
Comparative evaluation of four different calcium-based medicaments as an indirect pulp capping agent: an in vivo study |
| 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. NITIN KARARIA |
| Designation |
PROFESSOR |
| Affiliation |
NIMS Dental college and hospital |
| Address |
Room no 5 Department of Conservative dentistry and Endodontics
Jaipur
RAJASTHAN
303121
India |
| Phone |
9829114149 |
| Fax |
|
| Email |
drnitinkararia@thedentist.name |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. NITIN KARARIA |
| Designation |
PROFESSOR |
| Affiliation |
NIMS Dental college and hospital |
| Address |
Room no 5 Department of Conservative Dentistry and Endodontics
Jaipur
RAJASTHAN
303121
India |
| Phone |
9829114149 |
| Fax |
|
| Email |
drnitinkararia@thedentist.name |
|
Details of Contact Person
Public Query
|
| Name |
Dr. NITIN KARARIA |
| Designation |
PROFESSOR |
| Affiliation |
NIMS Dental college and hospital |
| Address |
Room no 5 Department of Conservative Dentistry and Endodontics
Jaipur
RAJASTHAN
303121
India |
| Phone |
9829114149 |
| Fax |
|
| Email |
drnitinkararia@thedentist.name |
|
|
Source of Monetary or Material Support
|
| Nims Dental college and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Ray Anuja Awadhesh |
| Address |
Room no 5 Department of Conservative Dentistry and Endodontics |
| Type of Sponsor |
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 NITIN KARARIA |
NIMS Dental college and Hospital |
room no.5 Department of Conservative Dentistry and Endodontics
Jaipur
RAJASTHAN |
09829114149
drnitinkararia@thedentist.name |
|
|
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 |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indirect pulp Capping |
To evaluate efficacy clinically by checking post operative pain , tenderness , neural sensibility and radiographically by checking PDL space widening , presence of calcific barrier and periapical radiolucency. |
| Comparator Agent |
TheraCal LC
Binar LC
Calcium Enriched Mixture (CEM) Cement
Calcium Hydroxide |
TheraCal LC (Bisco Inc., USA) is a light-cured, resin-modified calcium silicate-based material that releases calcium ions, promotes dentin bridge formation, and provides a protective barrier over the pulp. It is radiopaque, bioactive, and can be applied directly to deep dentin. It sets via light activation and has favorable handling properties.
Binar LC (Prevest DenPro, India) is a light-curable calcium hydroxide material embedded in a resin matrix. It offers direct pulp protection, promotes hard tissue formation, and has antibacterial effects due to the high pH of calcium hydroxide. The light-cured nature allows for easy placement and immediate setting.
CEM Cement (BioniqueDent, Iran) is a hydrophilic, biocompatible material composed of calcium compounds. It releases calcium and phosphate ions, leading to hydroxyapatite formation at the dentin-pulp interface. It has sealing ability, antibacterial properties, and induces dentinogenesis. It sets in a moist environment and has been used as a pulp capping and root repair material.
Calcium Hydroxide (e.g., Dycal, Dentsply, USA) is a chemically setting liner that has been the gold standard for indirect pulp capping. It works by releasing hydroxyl ions, creating a highly alkaline environment that is bactericidal and stimulates reparative dentin formation. However, it shows limitations like poor sealing and high solubility over time. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Tooth should be a mature permanent tooth showing a closed apex on periapical radiograph.
Tooth should have carious penetration in dentin in more than half (or threequarters) the thickness of its dentin bulk as seen in periapical radiograph and diagnosed as reversible pulpitis
Should have a positive response to Cold test that will confirm Neural sensibility
Absence of prolonged spontaneous pain
|
|
| ExclusionCriteria |
| Details |
Deciduous teeth
.No pulpal exposure post completion of caries removal
Teeth with necrosed pulp
Teeth with incomplete root formation
Teeth diagnosed with irreversible pulpitis with or without periapical lesion as diagnosed from radiograph
Teeth affected by periodontitis
Cracked tooth
Teeth showing internal or external resorption
Calcified canals
Failure to achieve pulpal hemostasis after accidental pin point exposure of pulp
Patients having systemic disease or is immunodeficient
Patient in pregnancy
13.Patient on antibiotic or analgesic course within a week prior to the start of treatment
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study primarily evaluated how effectively four calcium-based materials—TheraCal LC, Binar LC, CEM Cement, and Calcium Hydroxide—reduced postoperative pain and preserved pulp vitality over a 6-month period following indirect pulp capping (IPC). |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate efficacy of Theracal LC as IPC agent clinically by checking post operative
pain , tenderness , neural sensibility and radiographically by checking PDL space
widening , presence of calcific barrier and periapical radiolucency. |
18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="6"
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
|
In this randomized in - vivo clinical study, 52 patients aged 17–40 years with reversible pulpitis underwent IPC procedures using one of the four test materials. Pain scores (VAS), pulp sensibility, and radiographic changes were monitored at 21 days, 3 months, and 6 months post-treatment. |