Skip to main content
Clinical Trials/CTRI/2025/09/095428
CTRI/2025/09/095428
Not yet recruiting
Not Applicable

Clinical and Radiographic Assessment of Pulpotomy in Diabetic and Non Diabetic individuals with Symptomatic Pulpitis A Randomized Clinical Trial

Kodipyaka Sushmitha1 site in 1 country80 target enrollmentStarted: October 15, 2025Last updated:

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

Sponsor
Kodipyaka Sushmitha
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Kodipyaka Sushmitha

MNR Dental College and Hospital

Study Sites (1)

Loading locations...

Similar Trials