To Evaluate Periapical Healing Post Full Pulpotomy in Teeth With and Without Apical Periodontitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Full pulpotomy in adults ≥18 years with restorable mandibular first or second molars diagnosed with irreversible pulpitis, with or without apical periodontitis..
- Who it may be relevant to
- Registry conditions: Apical Periodontitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
To Evaluate Periapical Healing Post Full Pulpotomy in Permanent Mandibular Teeth With and Without Apical Periodontitis
Overview
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
- Procedure 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
Primary outcome measures
- Success following complete pulpotomy [Time frame: 12 MONTHS]
Eligibility criteria
Inclusion criteria
- The patient should be ≥18 years of age.
- Restorable mature permanent 1st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement)
- Tooth should give positive response to pulp sensibility testing.
- Radiographic finding of periapical index (PAI) score >/=3 (for test group) , score </= 2 (for control group)
Exclusion criteria
- Teeth with immature roots.
- No pulp exposure after caries excavation.
- Bleeding could not be controlled in 10 minutes.
- Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.
- History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.
- Internal/external resorption.
- Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
India · 1 center
- PGIDS, Rohtak — Rohtak
Identifiers
NCT: NCT07179835 · Jigyasa Duhan