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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07179835
Enrollment
128
Registered
2025-09-18
Start date
2025-10-15
Completion date
2027-10-01
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis

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.

Interventions

PROCEDUREFull 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

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Success following complete pulpotomy12 MONTHSClinical-Radiographic Success After Full Pulpotomy in Mandibular Molars With and Without Apical Periodontitis

Countries

India

Contacts

Primary ContactJigyasa Duhan, MDS
prashitiduhan@rediffmail.com9896270449

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026