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
|
|
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. |