| CTRI Number |
CTRI/2025/05/086122 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using Your Own blood to Heal Tooth Damage due to decay: A Study on Treatment for Cavities in Adults |
|
Scientific Title of Study
|
Effectiveness of Autologous Platelet Concentrate for Vital Pulp Therapy in Adult Patients with Carious Pulp Exposure- 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 |
Nishanthine Cruz |
| Designation |
professor |
| Affiliation |
sri venkateswara dental college |
| Address |
Department of conservative dentistry and endodontics,
Sri venkateswara dental college and hospital ,Off.Old Mahabalipuram Road, Thalambur Rd, Near navalur, Chennai, Tamil Nadu 600130
Kancheepuram
TAMIL NADU
600130
India |
| Phone |
9443978405 |
| Fax |
|
| Email |
nishanthineandrews29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nishanthine Cruz |
| Designation |
professor |
| Affiliation |
sri venkateswara dental college |
| Address |
department of conservative dentistry and endodontics, sri venkateswara dental college and hospital,Off.Old Mahabalipuram Road, Thalambur Rd, Near navalur, Chennai, Tamil Nadu 600130
Kancheepuram
TAMIL NADU
600130
India |
| Phone |
9443978405 |
| Fax |
|
| Email |
nishanthineandrews29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nishanthine Cruz |
| Designation |
professor |
| Affiliation |
sri venkateswara dental college |
| Address |
department of conservative dentistry and endodontics,Sri venkateswara dental college and hospital, Off.Old Mahabalipuram Road, Thalambur Rd, Near navalur, Chennai, Tamil Nadu 600130
Kancheepuram
TAMIL NADU
600130
India |
| Phone |
9443978405 |
| Fax |
|
| Email |
nishanthineandrews29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Nishanthine C |
| Address |
department of conservative dentistry and endodontics, Sri venkateswara dental college and hospital ,Off.Old Mahabalipuram Road, Thalambur Rd, Near navalur, Chennai, Tamil Nadu 600130 |
| 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 Nishanthine Cruz |
sri venkateswara dental college and hospital |
department of conservative dentistry and endodontics, sri venkateswara dental college and hospital, Off.Old Mahabalipuram Road, Thalambur Rd, Near navalur, Chennai, Tamil Nadu 600130
Kancheepuram
TAMIL NADU |
9443978405
nishanthineandrews29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee and scientific review board |
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 |
| Intervention |
autologous platelet concentrate(platelet rich fibrin) |
autologous platelet concentrate(platelet rich fibrin) as vital pulp capping agent in caries exposed mandibular molars |
| Comparator Agent |
Biodentine |
Biodentine is calcium silicate based cement widely used as a vital pulp capping agent in caries exposed mandibular molars |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
30 healthy participants of age group 18 to 45 years
Asymptomatic molars with caries exposure
Non tender to percussion.
Normal response to cold and electric pulp testing.
Radiographic evidence of deep caries near the pulp, with no signs of periodontal ligament thickening, furcation radiolucencies, or periapical pathology
|
|
| ExclusionCriteria |
| Details |
Symptomatic teeth
Radiographic evidence of periapical pathology.
Negative response to pulp sensibility testing.
History of systemic diseases.
Periodontally compromised teeth.
Patients with bleeding disorders or platelet count less than 150,000 per cubic mm.
Poor oral hygiene maintenance.
Pregnant or lactating females.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Teeth treated are expected to demonstrate three dimensional dentin bridge formation, which is an indicator of pulp preservation and pulp regeneration |
CBCT analysis will be done before treatment and after 1 year of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| teeth treated are expected to respond normally to pulp sensibility testing and should demonstrate normal periapical tissues in radiographic assessment |
pulp sensibility and radiographic assessment will be done preoperatively and 3,6,9,12 months after intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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 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 this study is to assess pulp sensibility and dentine bridge formation using CBCT imaging following direct pulp capping with PRF (platelet-rich fibrin), PRF combined with Biodentine, and Biodentine in permanent mandibular molars with carious pulp exposure. Objective: The objective is to assess the effectiveness of an autologous platelet concentrate for direct pulp capping by evaluating the clinical symptomology, pulp sensibility and radiographic three- dimensional dentin bridge formation after one year. Methodology: This is a prospective, randomized controlled trial. The efficacy of Biodentine, PRF, and PRF with Biodentine will be compared as direct pulp capping agents. The study will involve 30 participants, with 10 in each group, based on a sample size calculation using G Power software. Inclusion and Exclusion Criteria: Participants aged 18-45 with asymptomatic molars or premolars and carious pulp exposure that meet specific clinical and radiographic criteria will be included. Exclusion criteria encompass symptomatic teeth, systemic diseases, and any factors that may affect healing. Data will be collected through clinical assessments (response to pulp sensibility tests, periodontal evaluations), radiographic analysis, and patient-reported outcomes. Results: CBCT will be used to analyze the volume of dentine bridges formed by Biodentine, PRF, and PRF with Biodentine as direct pulp capping agents. Responses to pulp sensibility testing will be assessed before the treatment and after the treatment at intervals of 3, 6, 9, and 12 months.
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