To Evaluate Periapical Healing Post Full Pulpotomy in Teeth With and Without Apical Periodontitis

Not Applicable

Not yet recruiting

• Conditions: Apical Periodontitis

• Registration Number: NCT07179835
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Brief Summary

This clinical study aims to evaluate the periapical and clinical healing outcomes of full pulpotomy using MTA in mandibular permanent molars diagnosed with symptomatic irreversible pulpitis. Patients will be stratified based on the presence or absence of apical periodontitis. Clinical and radiographic assessments will be conducted at baseline, 6 months, and 12 months to compare healing outcomes between groups. The study seeks to determine the effectiveness of full pulpotomy as a less invasive alternative to root canal treatment, even in teeth with apical pathosis.

Detailed Description

This prospective clinical study aims to evaluate the periapical and clinical healing outcomes of full pulpotomy using mineral trioxide aggregate (MTA) in mandibular permanent molars diagnosed with symptomatic irreversible pulpitis. Patients will be stratified based on the presence or absence of apical periodontitis. Clinical and radiographic assessments will be conducted at baseline, 6 months, and 12 months to compare healing outcomes between groups. The study seeks to determine the effectiveness of full pulpotomy as a less invasive alternative to root canal treatment, even in teeth with apical pathosis.

Study Timeline

• Study First Submitted: 2025-07-21
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Study Start: 2025-10-15
• Primary Completion: 2027-04-15
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1. The patient should be ≥18 years of age.
2. Restorable mature permanent 1st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement)
3. Tooth should give positive response to pulp sensibility testing.
4. Radiographic finding of periapical index (PAI) score >/=3 (for test group) , score </= 2 (for control group)

Exclusion criteria

1. Teeth with immature roots.
2. No pulp exposure after caries excavation.
3. Bleeding could not be controlled in 10 minutes.
4. Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.
5. History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.
6. Internal/external resorption.
7. Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Success following complete pulpotomy	12 MONTHS	Clinical-Radiographic Success After Full Pulpotomy in Mandibular Molars With and Without Apical Periodontitis"

Trial Locations

Locations (1)

PGIDS, Rohtak; 🇮🇳 Rohtak, Haryana, India