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

Postgraduate Institute of Dental Sciences Rohtak

Status: Not yet enrolling

Conditions: Apical Periodontitis

Treatments: Procedure: Full pulpotomy in adults ≥18 years with restorable mandibular first or second molars diagnosed with irreversible pulpitis, with or without apical periodontitis.

Study type: Interventional

Funder types: Other

Identifiers

NCT07179835

Jigyasa Duhan

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

To evaluate success of full pulpotomy in mandibular permanent with apical periodontitis

Experimental group

Description:

To evaluate success of full pulpotomy based on clinical and radiographic criteria in mandibular permanent with apical periodontitis

Treatment:

Procedure: Full pulpotomy in adults ≥18 years with restorable mandibular first or second molars diagnosed with irreversible pulpitis, with or without apical periodontitis.

To evaluate success of full pulpotomy in mandibular permanent without apical periodontitis

Experimental group

Description:

To evaluate and compare success of full pulpotomy based on clinical and radiographic criteria in mandibular permanent withoutapical periodontitis

Treatment:

Procedure: Full pulpotomy in adults ≥18 years with restorable mandibular first or second molars diagnosed with irreversible pulpitis, with or without apical periodontitis.