| 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
|
|
|
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
|
|
|
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. |