| CTRI Number |
CTRI/2025/07/090864 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study Comparing Calcium Hydroxide, Bio-C Repair, and Calcimol-LC for Treating Deep Cavities in Lower First Molars” |
|
Scientific Title of Study
|
Comparative Evaluation of Treatment Outcomes Of Indirect Pulp Capping Using Calcium Hydroxide, Bio-C Repair, And Calcimol-LC In Permanent Mandibular First Molars With Deep Carious Lesion: A Randomized Controlled 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 Diksha Kumari |
| Designation |
Postgraduate Junior Resident, Endo |
| Affiliation |
Himachal Dental College and Hospital Sundernagar |
| Address |
Himachal Dental College and Hospital, Department of Conservative Dentistry and Endodontics, Sunder Nagar, Mandi, Himachal Pradesh Mandi
HIMACHAL PRADESH
175019 India
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
8219073142 |
| Fax |
01907267183 |
| Email |
ssdiksha628@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay kumar |
| Designation |
Professor |
| Affiliation |
Himachal Dental College, Sundernagar, |
| Address |
Himachal Dental College and Hospital, Department of Conservative Dentistry and Endodontics, Sunder Nagar, Mandi, Himachal Pradesh Mandi
HIMACHAL PRADESH
175019 India
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
7650000300 |
| Fax |
01907267183 |
| Email |
drvk9900@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay kumar |
| Designation |
Professor |
| Affiliation |
Himachal Dental College, Sundernagar, |
| Address |
Himachal Dental College and Hospital, Department of Conservative Dentistry and Endodontics, Sunder Nagar, Mandi, Himachal Pradesh Mandi
HIMACHAL PRADESH
175019 India
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
7650000300 |
| Fax |
01907267183 |
| Email |
drvk9900@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| HIMACHAL DENTAL COLLEGE SUNDERNAGAR ,PIN CODE -175019 |
|
|
Primary Sponsor
|
| Name |
Dr Diksha kumari |
| Address |
Himachal Dental College and Hospital, Department of Conservative Dentistry and Endodontics, Sunder Nagar, Mandi, Himachal Pradesh 175019 |
| Type of Sponsor |
Other [self] |
|
|
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 vijay kumar |
Himachal Dental College and HospitaL Sundernagar |
Himachal Dental College and Hospital, Department of Conservative Dentistry and Endodontics, Sunder Nagar, Mandi, Himachal Pradesh 175019
Mandi
HIMACHAL PRADESH |
7650000300
01907267183
ssdiksha628@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE OF HIMACHAL DENTAL COLLEGE, SUNDERNAGAR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
bio -c repair and calcimol lc |
Bio-C Repair is a bioceramic-based material with excellent bioactivity and sealing ability.
2. It promotes hard tissue formation and maintains a moist environment, ideal for pulp healing.
3. Its alkaline pH gives it strong antibacterial properties similar to calcium hydroxide.
4. It is premixed, radiopaque, and biocompatible, making it a reliable choice for vital pulp therapy.
1. Calcimol LC is a light-cured calcium hydroxide-based liner, used in IPC for its quick setting and ease of use.
2. It provides a mechanical barrier and releases calcium ions that aid in dentin bridge formation.
3. Being light-curable, it offers instant polymerization and better control during placement.
4. However, it may have limited long-term bioactivity compared to pure bioceramics like Bio-C Repair.
• Pulp capping material will be applied to the cavity floor and the pulp capping material will be covered by GIC.
• Following pulp capping, the cavity will be restored with composite resin.
• Clinical evaluation and follow-up of the cases regarding pulpal response to EPT and
cold tests will be recorded at intervals of 1 week, 3 months, and 6 months. |
| Intervention |
calcium hydraoxide |
1. Calcium hydroxide is widely used in indirect pulp capping due to its excellent antibacterial properties.
2. It promotes the formation of tertiary dentin by stimulating odontoblast-like cell activity.
3. The high pH of calcium hydroxide creates an alkaline environment, aiding in pulp healing and reducing inflammation.
4. Despite its benefits, it has poor sealing ability and may degrade over time, necessitating a proper coronal seal.• Pulp capping material will be applied to the cavity floor and the pulp capping material will be covered by GIC.
• Following pulp capping, the cavity will be restored with composite resin.
• Clinical evaluation and follow-up of the cases regarding pulpal response to EPT and
cold tests will be recorded at intervals of 1 week, 3 months, and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
40.00 Day(s) |
| Gender |
Both |
| Details |
Patients aged between eighteen to forty years.
Presence of deep carious lesions without pulp exposure, with radiographic depth reaching three-fourths of the dentin.
Positive response to pulp sensibility tests, including Electric Pulp Test and cold test.
No history of spontaneous pain.
No evidence of periodontal ligament space widening.
Permanent molars with adequate coronal tooth structure suitable for restoration. |
|
| ExclusionCriteria |
| Details |
Presence of periapical pathology such as periapical radiolucency or root resorption.
Extensive loss of coronal tooth structure requiring prosthetic rehabilitation.
Presence of caries extending below the gingival margin.
History of chronic or recurrent pain associated with the affected tooth.
Presence of soft tissue swelling or sinus tract.
Teeth with open apices or pathological mobility.
Teeth that have been previously treated endodontically or restored in the area under study.
Patients with known systemic health complications. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Check pulpal response using EPT/Cold Test at intervals of 1 week, 3 months and 6 months post-procedure. |
Check pulpal response using EPT/Cold Test at intervals of 1 week, 3 months and 6 months post-procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical symptoms & comparative success rates |
1st week 3 month & 6 month |
|
|
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 3 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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="7"
Days="3" |
|
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 clinical trial will be conducted in the Department of Conservative Dentistry and Endodontics, Himachal Dental College & Hospital, Sundernagar, Himachal Pradesh.
After obtaining informed consent from the patients (Annexure I attached), they will be randomly allocated into three groups:
Group A: Calcium Hydroxide Group B: Bio-C Repair Group C: Calcimol LC
For the purpose of the clinical trial, the pulpal response using Electric Pulp Test (EPT) and cold test will be recorded as a baseline reference.
If required (in cases of severe sensitivity during cavity preparation, rinsing, or in patients with dental phobia), the tooth will be anesthetized using 2% lignocaine containing 1:80,000 adrenaline. Isolation of the tooth will be achieved using a rubber dam.
A sterile diamond bur will be used in a high-speed handpiece under constant water spray. Carious tissue will be identified and removed with the aid of a caries detector dye. The dye will be applied to cavity walls to stain demineralized carious tissue, allowing precise identification of infected dentine.
Stained, demineralized tissue will be removed, starting from the peripheral walls toward the center of the lesion. Selective caries removal will be done carefully to reach relatively firm, non-stained dentine. This step will be guided by both visual and tactile feedback to avoid accidental pulp exposure.
Necrotic carious fragments will be removed with a spoon excavator, followed by a round bur in a low-speed handpiece with water cooling. A fresh sterile bur will be used in deeper areas of the lesion to reduce microbial contamination and prevent the introduction of infected dentine into the pulp.
The prepared cavity will be rinsed with normal saline to remove residual dye and then gently dried.
Pulp capping material (based on group allocation) will be applied to the cavity floor. This material will be covered by a layer of Glass Ionomer Cement (GIC).
Subsequently, the cavity will be restored with composite resin.
Pulpal response using EPT and cold test will be evaluated at 1 week, 3 months, and 6 months post-procedure for follow-up and clinical assessment.
|