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CTRI Number  CTRI/2025/06/089802 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 28/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Saving Baby Teeth: A Study on Two Safe Dental Materials for Children  
Scientific Title of Study   Comparative evaluation of Bio-C Repair and Biodentine as pulpotomy agents in primary molars: A clinical 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 KRUTHI H G 
Designation  Post graduate  
Affiliation  The Oxford Dental College 
Address  The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room NO.8, Bommanahalli, Hongasandra Bangalore
The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room NO.8, Bommanahalli, Hongasandra Bangalore
Bangalore
KARNATAKA
560068
India 
Phone  9353217292  
Fax    
Email  kruthihg25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR KRUTHI H G 
Designation  Post graduate  
Affiliation  The Oxford Dental College 
Address  The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room NO.8, Bommanahalli, Hongasandra Bangalore
The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room NO.8, Bommanahalli, Hongasandra Bangalore
Bangalore
KARNATAKA
560068
India 
Phone  9353217292  
Fax    
Email  kruthihg25@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR KIRAN K 
Designation  Professor and Head of Department ,Department of Pediatric and Preventive Dentistry,The Oxford Dental College. 
Affiliation  The Oxford Dental College 
Address  The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room NO.8, Bommanahalli, Hongasandra Bangalore
The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room NO.8, Bommanahalli, Hongasandra Bangalore
Bangalore
KARNATAKA
560068
India 
Phone  9731196369  
Fax    
Email  drkkiran@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  DR KRUTHI H G 
Address  The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room NO.8, Bommanahalli, Hongasandra Bangalore 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR KRUTHI H G  The Oxford Dental College  The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room NO.8, Bommanahalli, Hongasandra Bangalore
Bangalore
KARNATAKA 		 9353217292

kruthihg25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR KRUTHI H G  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bio C repair   Bio C repair will be mixed as per manufacturers instructions and will be placed on the floor of the pulp chamber.  
Comparator Agent  Biodentine   Biodentine will be mixed as per manufacturers instructions and will be placed on the floor of the pulp chamber  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Healthy cooperative patient.
2. Absence of pulp degeneration.
3. Absence of spontaneous or persistent pain.
4. Absence of abscess and intraoral sinus.
5. Bright red bleeding on pulp amputation.
6. Presence of two-third of root.
7. Teeth which can be restored with crown.
 
 
ExclusionCriteria 
Details  1. History of spontaneous pain.
2. Presence of swelling or sinus tract.
3. Tooth with preshedding mobility.
4. Evidence of pathological internal/ external resorption of root.
5. Pathological tooth mobility.
6. Presence of furcation and interradicular radiolucency.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To clinically and radiographically evaluate Bio-C repair as a pulpotomy agent and compare it with that of Biodentine in primary molars.  one and half year. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   24/07/2025 
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="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  

Sixty primary molars will be allocated by simple randomization technique to two groups of 30 teeth each:

 Group (I) : Bio-C repair (Angelus, Londrina, PR, Brazil).

 Group (II): Biodentine (Septodont, Saint-Maur-des-Fosses, France).

The tooth will be anaesthetized using 2% lignocaine hydrochloride containing adrenaline at a concentration of 1:80000 and will be isolated using rubber dam. Dental caries and overhanging enamel will be removed with a #330 high speed bur with water spray and access to coronal pulp will be gained. The entire roof of the pulp chamber will be removed and coronal pulp will be amputated with a sterile sharp discoid spoon excavator until the root canal orifices are seen, with no tags remaining on the pulpal floor. Haemorrhage will be controlled using slightly moistened cotton pellets placed on the pulp stumps at the orifices of the root canal. Following the achievement of hemostasis,

 Group (I): Bio-C repair will be mixed as per manufacturer’s instructions and will

                  be placed on the floor of the pulp chamber.

 Group (II): Biodentine will be mixed as per manufacturer’s instructions and will be

                   placed on the floor of the pulp chamber.

In both groups, all the teeth will be restored with a type II glass ionomer cement (Shofu, Shofuinc, Japan) and composite resin (Tetric-N-flow Bulk Fill, Ivoclar, Vivadent, Schaan, Liechtenstein). An immediate postoperative intra oral periapical radiograph will be taken. Stainless steel crowns will be placed within 1 week of the restoration. Patients will be recalled after 1, 3, 6 and 12 month intervals for clinical evaluation. The radiographic evaluation will be done at the end of one year according to the following criteria2:

Clinical criteria:

     1.  Symptoms of pain.

     2.  Tenderness on percussion.

     3.  Presence of swelling.

     4.  Presence of fistula or sinus.

     5.  Pathological mobility.

Radiographic criteria:

    1.  Periodontal ligament space widening.

    2.  Periapical radiolucency.

    3.  Furcal radiolucency.

    4.  Internal resorption.

    5. External resorption.

Data obtained will be subjected to statistical analysis.

 
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