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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2027-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Apical Periodontitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Comparison of full pulpotomy with MTA in teeth with and without apical periodontitis

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

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Comparison of full pulpotomy with MTA in teeth with and without apical periodontitis

Interventions

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

Comparison of full pulpotomy with MTA in teeth with and without apical periodontitis

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No