Molecular Approaches to develop Objective Diagnostic Tools in Vital Pulp Treatment
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Vitality of pulpotomised tooth
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
Vitality of pulpotomised tooth
Time Frame: 1 year
Secondary Outcomes
- Levels of biomarkers in pulp tissue(1 year)