NCT07340606

Brief Summary

This study aims to evaluate the effect of prognostic factors, such as the severity of pulpal inflammation, carious pulp exposure, and the presence of apical periodontitis, on the success of full pulpotomy in mature permanent molars with irreversible pulpitis. It also aims to investigate the role of artificial intelligence-assisted diagnosis in predicting the prognosis of full pulpotomy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
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 Progress49%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

January 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

January 17, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 5, 2026

Last Update Submit

January 17, 2026

Conditions

Pulpitis - Irreversible

Keywords

irreversible pulpitisfull pulpotomyartificial intelligenceapical periodontitis

Outcome Measures

Primary Outcomes (2)

  • Percentage of Successful Cases

    * It will be measured as a percentage. * It will be decided according to the clinical and radiographic criteria of success and failure.

    After 1, 3, and 6 months.

  • Diagnostic Accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure

    The artificial intelligence (AI) software will process pre-operative radiographs to predict the presence of carious pulp exposure. The AI findings will be compared to the clinical findings of carious pulp exposure after caries removal. (Clinical findings of carious pulp exposure will be used as the gold standard). -The outcome will be reported as sensitivity and specificity.

    On the day of the procedure

Study Arms (2)

Root Canal Treatment

ACTIVE COMPARATOR

The patients allocated to this arm will receive conventional root canal treatment. They will be followed up for 1, 3, and 6 months to assess clinical and radiographic success.

Procedure: Conventional root canal treatment

Full Pulpotomy

EXPERIMENTAL

The patients allocated to this arm will receive full pulpotomy. They will be followed up for 1, 3, and 6 months to assess clinical and radiographic success.

Procedure: Full pulpotomy

Interventions

Conventional root canal treatmentPROCEDURE

The patients will receive conventional root canal treatment, which is the gold standard treatment protocol in cases with irreversible pulpitis.

Root Canal Treatment
Full pulpotomyPROCEDURE

The patients will receive full pulpotomy as follows: -Under rubber dam isolation, the operator will perform caries removal, complete the access cavity preparation, achieve hemostasis in all canals, and apply the bioceramic material. The operator will seal the cavity with a glass ionomer restoration.

Full Pulpotomy

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Mature permanent molars with irreversible pulpitis.
  • Presence of bleeding from all canals.
  • The tooth is not periodontally compromised.

You may not qualify if:

  • Non-vital teeth.
  • Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent.
  • Molars with immature roots.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Misr International University (MIU)

Cairo, Egypt

RECRUITING

Misr International University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Officials

  • Ahmed M Ghobashy, Prof. Dr.

    Misr International University

    STUDY DIRECTOR

  • Mayand A Amer, B.D.S.

    Misr International University

    PRINCIPAL INVESTIGATOR

  • Marwan S Ibrahim, B.D.S.

    Misr International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayand A Amer, B.D.S.

CONTACT

01062509703mayand.amer@miuegypt.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 14, 2026

Study Start

January 17, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share
Shared Documents
SAP

Locations

EG(2)