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CTRI Number  CTRI/2024/06/069218 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 15/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   "Comparing Tooth Repair Medicines After Laser and Traditional Pulp Therapy: Which Works Better?" 
Scientific Title of Study   Comparative evaluation of clinical and radiographic success of Biodentine and Bioceramic as a pulp medicament after Laser and conventional pulpotomy in primary molars- A double blinded randomized controlled trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr DHIVYA SHANTHI 
Designation  post graduate 
Affiliation  Adhiparasakthi Dental College and Hospital 
Address  Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital, Melmaruvathur

Kancheepuram
TAMIL NADU
603319
India 
Phone  9790409028  
Fax    
Email  2223215@apdch.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr A Selvabalaji 
Designation  Reader 
Affiliation  Adhiparasakthi Dental College and Hospital 
Address  Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital Melmaruvathur

Kancheepuram
TAMIL NADU
603319
India 
Phone  9003604774  
Fax    
Email  selvabalaji88@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr DHIVYA SHANTHI 
Designation  post graduate 
Affiliation  Adhiparasakthi Dental College and Hospital 
Address  Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital Melmaruvathur

Kancheepuram
TAMIL NADU
603319
India 
Phone  9790409028  
Fax    
Email  2223215@apdch.edu.in  
 
Source of Monetary or Material Support  
Dental OPD in Adhiparasakthi Dental College and Hospital and Dental camps Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital, Melamruvathur-603319, Tamilnadu, India. 
 
Primary Sponsor  
Name  Dr S Dhivya Shanthi 
Address  Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital, Melmaruvathur-603319 
Type of Sponsor  Other [Self ] 
 
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 
Dhivya Shanthi S  Adhiparasakthi dental college and hospital  Room no:6, first floor, Department of Pediatric and Preventive dentistry, Melmaruvathur-603319.
Kancheepuram
TAMIL NADU 
9790409028

dhivyadhivya484@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board- Adhiparasakthi Dental College and Hospital  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  Bioceramic and Laser pulpotomy in primary molars  For laser pulpotomy, the pulp is ablated to the level of the canal orifice using diode laser with 980 nm wavelength, 0.8 W of power and on pulse mode. The laser energy is delivered through a 0.5 mm diameter optical fiber in contact with pulp tissue with the total energy of one spot, corresponding to 2 minutes. If additional ablation is required, subsequent multiple applications are administered. Over this, bioceramic is placed, and access cavity restoration is done using glass ionomer cement (GIC). Pre- and postoperative radiographs will be taken. The children is recalled for clinical and radiographic follow-up at 1 and 3months.  
Comparator Agent  Conventional pulpotomy  The coronal portion of the pulp will excise leaving behind the intact untouched radicular pulp, and finally, irrigation will be done with saline to remove the dentinal debris. A cotton pellet dipped with saline will be placed over the root canal orifice, and pressure is applied to attain hemostasis. Over this, a biodentine will be placed, and access cavity restoration is done using glass ionomer cement (GIC). Pre- and postoperative radiographs will be taken. The children is recalled for clinical and radiographic follow-up at 1 and 3months. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Primary molar tooth not more than one-third of root resorption.
Children with deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically.
 
 
ExclusionCriteria 
Details  Children with special health care needs and systemic illness
Primary molars with any congenital deformities.
 
 
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 
All cause morbidity at 3 months. Success rate of pulpotomy at 3 months (defined as absence of clinical symptoms and radiographic signs of pathology).  baseline, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
All cause morbidity at 1, 3 months. Incidence of post-operative pain,
Incidence of post-operative infection,
Radiographic evidence of root resorption 
at baseline, 1 month, 3 months 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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/ Phase 4 
Date of First Enrollment (India)   15/07/2024 
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="1"
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  

The aim of the study is to determine the clinical and radiographic success of biodentine and bioceramic as a pulp medicament after laser and conventional pulpotomy in primary molars.

Dental caries have a higher prevalence rate in children, especially in mixed dentition period due to their diet pattern change or lack in maintaining proper oral hygiene.

 In case of dental caries with pulpal involvement, preserving the natural tooth by pulp therapy until its time of exfoliation is a vital aim in pediatric dental management, as they are said to be the most best space maintainers.

Vital pulpotomy is the clinical treatment of choice for primary teeth with exposed pulp.

Objectives:

·       To use laser as a pulpotomy material in comparison with the gold standard glutaraldehyde pulpotomy.  

·       To assess the clinical and radiographic success rate of glutaraldehyde pulpotomy and laser pulpotomy.

·       To compare the success rate of two different materials- biodentine and bioceramic as a medicament for pulpotomy.

 

Methodology:

Total sample size 60 collected from OPD,Department of Pediatric and Preventive Dentistry, APDCH and samples are divided into 4 groups . Group1 -15 no for Glutaraldehyde pulpotomy and Biodentine. Group2- 15 no for glutaraldehyde pulpotomy and Bioceramic. Group3- 15 no for laser pulpotomy and Biodentine. Group4- 15 no for laser pulpotomy and Bioceramic. After administration of local anesthesia, the teeth will isolate with rubber dam. The soft carious lesions will first excavate using a spoon excavator, followed by which access opening will perform using no-330 high-speed bur with the airotor.  Following the initial drop into the pulp chamber, the tooth will reassure by operative diagnosis by analyzing the nature of the pulpal bleeding. If the nature of bleeding is cyanotic instead of inflammatory, then the teeth will dismiss for pulpectomy and will eliminate from the study. Satisfying the operatory diagnosis, the treatment will continue, the pulp chamber is completely deroofed. The coronal portion of the pulp will excise leaving behind the intact untouched radicular pulp, and finally, irrigation will be done with saline to remove the dentinal debris. A cotton pellet dipped with saline will be placed over the root canal orifice, and pressure is applied to attain hemostasis, followed by which glutaraldehyde pulpotomy and laser pulpotomy will be carried in their respective groups. For glutaraldehyde pulpotomy, a cotton soaked with glutaraldehyde will place over the amputated radicular pulp area over the root canal orifice for 4 minutes. (Garcia Godoy -1987). Upon removal of the cotton pellet, a dark brown layer of fixation can be appreciated. Over this, a biodentine in one group and bioceramic in another group will be placed, and access cavity restoration is done using glass ionomer cement (GIC). For laser pulpotomy, the pulp will be ablated to the level of the canal orifice using diode laser with 980 nm wavelength, 0.8 W of power and on pulse mode. The laser energy will deliver through a 0.5 mm diameter optical fiber in contact with pulp tissue with the total energy of one spot, corresponding to 2 minutes. If additional ablation is required, subsequent multiple applications will be administered. Over this, a biodentine in one group and bioceramic in another group will be placed, and access cavity restoration is done using glass ionomer cement (GIC) type II. Pre- and postoperative radiographs will be taken. The children will be initially assessed on the same day and will be recalled for clinical and radiographic follow-up at 1 and 3months.

 Clinical and radiographic success and failure rate will be evaluated based on Zurn & Seale (2008) scoring system.

Inclusion criteria:

  • Primary molar tooth not more than one-third of root resorption.
  • Children with deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically.

Exclusion criteria:

  • Children with special health care needs
  • Children under systemic illness
  • Primary molars with any congenital deformities.

Statistical analysis: Chi-square test will be performed.

 

 
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