NCT07179835

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Oct 2025Oct 2027

First Submitted

Initial submission to the registry

July 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

July 21, 2025

Last Update Submit

September 15, 2025

Conditions

Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Success following complete pulpotomy

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

    12 MONTHS

Study Arms (2)

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

EXPERIMENTAL

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

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

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

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

Interventions

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

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIDS, Rohtak

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Central Study Contacts

Jigyasa Duhan, MDS

CONTACT

9896270449prashitiduhan@rediffmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2025

First Posted

September 18, 2025

Study Start

October 15, 2025

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)