| CTRI Number |
CTRI/2026/03/105366 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Three Methods for Treating Deep Dental Cavities in Children |
|
Scientific Title of Study
|
Comparative evaluation of selective caries removal to firm dentin, selective caries removal to soft dentin with 5% sodium hypochlorite lavage, and selective caries removal to soft dentin with Biodentine liner placement: 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 |
Deepika Singh |
| Designation |
Pg Student |
| Affiliation |
Pt B D Sharma Post Graduate Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive dentistry (Room no 19), Post Graduate Institute of Dental Sciences, Rohtak, 124001, Haryana
Department of Pediatric and Preventive dentistry (Room no 19), Post Graduate Institute of Dental Sciences, Rohtak, 124001, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8684972702 |
| Fax |
|
| Email |
i.drdeepikasingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu Namdev |
| Designation |
Professor and Head of Department |
| Affiliation |
Pt B D Sharma Post Graduate Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive dentistry (Room no 19), Post Graduate Institute of Dental Sciences, Rohtak, 124001, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9466856929 |
| Fax |
|
| Email |
ritunamdev@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr, Ritu Namdev |
| Designation |
Professor and Head of Department |
| Affiliation |
Pt B D Sharma Post Graduate Institute of Dental Sciences |
| Address |
Dr. Ritu Namdev (Professor and Head of Department)
Department of Pediatric and Preventive dentistry (Room no 19), Post Graduate Institute of Dental Sciences, Rohtak, 124001, Haryana
Email: ritunamdev@rediffmail.com
Contact: 9466856929
Rohtak
HARYANA
124001
India |
| Phone |
9466856929 |
| Fax |
|
| Email |
ritunamdev@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| None(The study is self-funded and no external monetary or material support was received) |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department of Pediatric and Preventive dentistry (Room no 19), Post Graduate Institute of Dental Sciences, Rohtak, 124001, Haryana
|
| Type of Sponsor |
Government medical 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 Deepika Singh |
Pt B D Sharma Post Graduate Institute of Dental Sciences, Rohtak |
Pt. B.D.Sharma Post Graduate Institute of Dental Sciences Rohtak, PGIDS Rohtak, Daryao Nagar, Rohtak, Haryana 124001
Rohtak
HARYANA |
8684972702
i.drdeepikasingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOMEDICAL AND HEALTH RESEARCHETHICS COMMITTEE, PGIDS, ROHTAK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SRFD with Biodentine liner |
Selective caries removal to firm dentin. Biodentine (calcium silicate cement) applied on the pulpal floor, followed by restoration with glass ionomer cement and composite. This group serves as the active control for comparison with SRSD techniques. |
| Intervention |
SRFD with Biodentine liner (control) |
Group 1 (Control): Selective caries removal to firm dentin (SRFD) followed by Biodentine liner placement.
|
| Intervention |
SRSD with 5% sodium hypochlorite lavage (Intervention 1) |
Group 2 (Intervention 1): Selective caries removal to soft dentin (SRSD) followed by lavage with 5% sodium hypochlorite for 3 minutes, restored with glass ionomer cement and composite. |
| Intervention |
SRSD with Biodentine liner (Intervention 2) |
Group 3 (Intervention 2): Selective caries removal to soft dentin (SRSD) followed by Biodentine liner placement, restored with glass ionomer cement and composite. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6–15 years of either gender, in good general health.
At least one permanent posterior tooth with deep carious lesion extending into ¾ of dentin, confirmed radiographically (ICDAS score 5–6).
Asymptomatic teeth on clinical evaluation (no spontaneous pain).
Parents/guardians providing written informed consent. |
|
| ExclusionCriteria |
| Details |
Negative response to cold test (–50 °C Endo-Frost spray).
Presence of spontaneous pain, pain on palpation/percussion, abscess, fistula, or swelling.
Non-carious lesions (attrition, abrasion, erosion, or abfraction).
Radiographic signs of periapical pathology (loss of lamina dura, periodontal ligament space widening, root canal obliteration, internal or external resorption).
Children with systemic illness or in poor general health.
Subjects unwilling to participate or whose parents do not provide consent. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Maintenance of pulp vitality (positive response to cold test, absence of spontaneous pain, absence of tenderness on percussion, absence of swelling/abscess/fistula).
Absence of radiographic signs of pathology (no periapical radiolucency, no widening of periodontal ligament space, no root resorption, no canal obliteration).
Pain assessment using Visual Analog Scale (VAS, 1–10). |
Immediate post-operative, 3 months, 6 months, 9 months, and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparative success rate between selective caries removal to soft dentin followed by 5% sodium hypochlorite lavage and selective caries removal to soft dentin followed by Biodentine liner.
Comparison of success rates of both SRSD techniques (NaOCl lavage and Biodentine liner) with selective caries removal to firm dentin (SRFD) with Biodentine liner (control group).
Survival of restoration and absence of secondary caries during follow-up. |
3 months, 6 months, 9 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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (link to be provided at the time of publication.).
- For how long will this data be available start date provided 01-10-2027 and end date provided 01-10-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Dental caries remains the most prevalent oral disease, with deep carious lesions posing a significant risk of pulpal exposure and loss of vitality. Contemporary minimally invasive strategies advocate selective caries removal to preserve pulp health while minimizing operative trauma.
This randomized controlled clinical trial will evaluate and compare the success of three treatment protocols in permanent teeth of children aged 6–15 years with deep carious lesions (ICDAS 5–6):
-
Selective caries removal to firm dentin (SRFD) followed by Biodentine liner placement (control group).
-
Selective caries removal to soft dentin (SRSD) followed by 5% sodium hypochlorite lavage.
-
Selective caries removal to soft dentin (SRSD) followed by Biodentine liner placement.
Seventy-five participants will be randomly allocated into three parallel groups (25 per group) using simple randomization with allocation concealment by opaque envelopes. Double blinding (patient and evaluator) will be maintained. Clinical and radiographic assessments, including pulp vitality, pain scoring (VAS), and absence of periapical pathology, will be performed at immediate, 3, 6, 9, and 12 months post-treatment.
The primary outcome is maintenance of pulp vitality with absence of clinical/radiographic signs of pathology. Secondary outcomes include comparative success rates between groups and restoration survival. This study aims to provide evidence on the efficacy of sodium hypochlorite lavage and Biodentine in vital pulp preservation in deep carious lesions. |