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NCT Number: NCT07179835

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. Success following complete pulpotomy

    Time frame: 12 MONTHS

    Clinical-Radiographic Success After Full Pulpotomy in Mandibular Molars With and Without Apical Periodontitis"

Study contacts

Contact information is provided by the study sponsor or research team.

Jigyasa Duhan, MDS

CONTACT

[email protected]

9896270449

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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