Evaluation of levels of Biomarkers in different stages of Pulpitis

Phase 3

Not yet recruiting

Conditions: Pulpitis,

Registration Number: CTRI/2023/11/059706

Lead Sponsor: Manipal College of Dental Sciences

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vitality of pulpotomised tooth	1 year

Secondary Outcome Measures

Name	Time	Method
Levels of biomarkers in pulp tissue	1 year

Trial Locations

Locations (1): Manipal College of Dental Sciences Manipal
🇮🇳
Udupi, KARNATAKA, India
Manipal College of Dental Sciences Manipal
🇮🇳Udupi, KARNATAKA, India
Dr Narkedamalli Raj Kumar
Principal investigator
8763864963
raj231994@gmail.com