Clinical and Radiographic Assessment of Pulpotomy in Diabetic and Non Diabetic individuals with Symptomatic Pulpitis A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Kodipyaka Sushmitha
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- CLINICAL OUTCOMES:
Overview
Brief Summary
This randomized clinical trial aims to evaluate and compare the clinical and radiographic outcomes of pulpotomy procedures in controlled diabetic and nondiabetic individuals diagnosed with symptomatic irreversible pulpitis. Participants will be allocated into two parallel groups (diabetic and nondiabetic) and will undergo a standardized pulpotomy treatment using biocompatible materials. Clinical parameters such as pain tenderness mobility along with radiographic findings ( periapical status,internal or extrnal resorption,hard tissue barrier formation), will be assessed at baseline 1month 3 months 6 months and 12 months post-treatment. The study seeks to determine whether systemic diabetic status influences the healing outcome and success of pulpotomy treatment in mature permanent teeth.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy and controlled diabetics with HbA1c value (5.7 to 7) Premolars and molars diagnosed with symptomatic pulpitis Presence of large carious lesions radiographically Moderate to severe pain with positive pulp sensibility tests Vital pulp tissue visible upon accessing the pulp chamber Hemostasis achieved within 10 minutes after pulpotomy.
Exclusion Criteria
- •Patients with ASA III,IV,V,VI 2) Pregnant women 3) Necrotic pulp or non-vital teeth 4)Teeth with periapical lesions 5)Presence of internal or external tooth resorption Failure to control bleeding within 10 minutes of the procedure.
Outcomes
Primary Outcomes
CLINICAL OUTCOMES:
Time Frame: 24hours 1week 12weeks 24weeks 48weeks
1 Absence of signs and symptoms of symptomatic pulpitis
Time Frame: 24hours 1week 12weeks 24weeks 48weeks
2 absence of swelling or sinus tract
Time Frame: 24hours 1week 12weeks 24weeks 48weeks
3 Absence of abnormal tooth mobility
Time Frame: 24hours 1week 12weeks 24weeks 48weeks
RADIOGRAPHIC OUTCOMES
Time Frame: 24hours 1week 12weeks 24weeks 48weeks
1 No sign of internal or external root resorption
Time Frame: 24hours 1week 12weeks 24weeks 48weeks
2 No new periapical pathosis
Time Frame: 24hours 1week 12weeks 24weeks 48weeks
3 Formation of hard tissue barrier
Time Frame: 24hours 1week 12weeks 24weeks 48weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Kodipyaka Sushmitha
MNR Dental College and Hospital