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CTRI Number  CTRI/2023/11/059706 [Registered on: 09/11/2023] Trial Registered Prospectively
Last Modified On: 08/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Evaluation of levels of Biomarkers in different stages of Pulpitis 
Scientific Title of Study   Molecular Approaches to develop Objective Diagnostic Tools in Vital Pulp Treatment 
Trial Acronym  VPT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Narkedamalli Raj Kumar 
Designation  Senior Lecturer 
Affiliation  Manipal Academy of Higher Education MAHE Manipal 
Address  Department of Conservative Dentistry and Endodontics Room no 2 Ground Floor Manipal College of Dental Sciences Madhav Nagar Opp ITC Fortune Inn Valley View Manipal

Udupi
KARNATAKA
576104
India 
Phone  8763864963  
Fax    
Email  raj231994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr N Vasudev Ballal 
Designation  Professor 
Affiliation  Manipal Academy of Higher Education MAHE Manipal 
Address  Department of Conservative Dentistry and Endodontics Room no 2 Ground Floor Manipal College of Dental Sciences Madhav Nagar Opp ITC Fortune Inn Valley View Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880626167  
Fax    
Email  drballal@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Narkedamalli Raj Kumar 
Designation  Senior Lecturer 
Affiliation  Manipal Academy of Higher Education MAHE Manipal 
Address  Department of Conservative Dentistry and Endodontics Room no 2 Ground Floor Manipal College of Dental Sciences Madhav Nagar Opp ITC Fortune Inn Valley View Manipal

Udupi
KARNATAKA
576104
India 
Phone  8763864963  
Fax    
Email  raj231994@gmail.com  
 
Source of Monetary or Material Support  
Manipal College of Dental Sciences Manipal Academy of Higher Education MAHE Madhav Nagar Opp ITC Fortune Inn Valley View Manipal 
 
Primary Sponsor  
Name  Manipal College of Dental Sciences 
Address  Madhav Nagar Opp ITC Fortune Inn Valley View Manipal KARNATAKA 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Manipal College of Dental Sciences Manipal  Madhav Nagar Opp ITC Fortune Inn Valley View Manipal KARNATAKA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Narkedamalli Raj Kumar  Manipal College of Dental Sciences Manipal  Department of Conservative Dentistry and Endodontics Room no 2 Ground Floor Manipal College of Dental Sciences Madhav Nagar Manipal
Udupi
KARNATAKA 
8763864963

raj231994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba 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  Full Pulpotomy  Full pulpotomy procedure will be done by complete removal of inflamed pulp tissue from the pulp chamber which will take 60 to 70 minutes 
Comparator Agent  Partial Pulpotomy  Partial pulpotomy procedure will be done by partial removal of non-inflamed pulp tissue from the pulp chamber which will take 60 to 70 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients with a healthy unrestored sound tooth premolars or molars with no signs of resorption or periodontal disease that is indicated for extraction for orthodontic purposes

Adult patients presenting with a deep or extremely deep carious lesion radiographically reaching close to the pulp inner quarter of dentine and signs and symptoms ranging between mild moderate and severe pain

Positive response to cold and electric pulp sensibility test and pulpal exposure during non selective removal of caries
 
 
ExclusionCriteria 
Details  More than 3mm periodontal probing depth for tooth of interest

Severe case of pulpitis where time taken to achieve haemostasis is more than 10mins

Necrotic pulp

Systemic conditions like Bleeding disorders uncontrolled hypertension diabetes patients on anticoagulant therapy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Vitality of pulpotomised tooth  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Levels of biomarkers in pulp tissue  1 year 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   27/11/2023 
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="4"
Months="0"
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  

This prospective study aims to revolutionize vital pulp treatment decisions by investigating biological markers in healthy and inflamed human pulp tissue. The research seeks to establish threshold levels of MMP-9 to guide treatment choices.

 

The significance of this study lies in addressing the controversy surrounding pulp exposure from trauma or caries. Current practices vary, with many opting for root canal treatment. Inflammation of dental pulp, pulpitis, results from microbial infection, primarily due to caries or trauma. Precise assessment of pulp inflammation is pivotal for successful Vital Pulp Treatment (VPT), yet data on ideal marker levels are scarce.

 

This four-year study involves 120 participants and collaboration across multiple departments. Biological material collection includes blood samples. Statistical analysis will determine marker levels and their significance.

 

The procedure involves blood sample collection, followed by marker detection. Post-operative evaluation after one year will ascertain treatment success. This study’s primary outcome is a composite measure of pain absence, apical periodontitis absence, and internal root resorption absence at one year. Secondary outcomes include absence of pain at 3 and 7 days post-operatively, tooth structural integrity, and correlation of MMP-9 levels with treatment outcomes.

 
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