NCT07768852

Brief Summary

This study will evaluate whether full pulpotomy can successfully treat mature permanent teeth with irreversible pulp inflammation and a periapical lesion. Full pulpotomy involves removing the inflamed pulp tissue from the crown of the tooth while preserving the healthy tissue inside the roots. The study will assess pain relief, patient satisfaction, and clinical and radiographic healing over time, including healing of the periapical lesion using dental X-rays and limited-field CBCT imaging. The findings may help determine whether full pulpotomy can provide a less invasive alternative to root canal treatment for selected teeth with periapical lesions.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
49mo left

Started Oct 2026

Longer than P75 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 7, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

August 17, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 8, 2026

Last Update Submit

August 12, 2026

Conditions

Keywords

PulpitisPeriapical lesionPulpotomyLaser

Outcome Measures

Primary Outcomes (1)

  • Success of pulpotomy

    Treatment success will be determined by the absence of clinical signs and symptoms of disease, together with radiographic evidence of healing or reduction of the periapical lesion.

    6 and 12 months

Secondary Outcomes (1)

  • Postoperative pain

    3 and 7 days after treatment

Other Outcomes (2)

  • Oral health-related quality of life

    Before treatment, 1 week and 12 months after treatment

  • Tooth Survival

    12, 24, and 36 months

Study Arms (1)

Pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis.

EXPERIMENTAL

Participants will receive full pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis. Treatment outcomes will be evaluated clinically and radiographically during follow-up.

Procedure: Full pulpotomy

Interventions

Full pulpotomy will be performed in permanent teeth with irreversible pulpitis and apical periodontitis, with diode laser-assisted hemostasis and calcium silicate-based pulp capping. The intervention is distinguished by the treatment of teeth with radiographic evidence of apical periodontitis using a full pulpotomy approach rather than conventional root canal treatment.

Also known as: Cervical pulpotomy, Coronal pulpotomy
Pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis.

Eligibility Criteria

Age8 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Non -contributory medical history (SAI, II).
  • Posterior permanent tooth (premolar, molar).
  • Age range 8-30 years
  • Deep caries extending into the inner quarter of dentin or exposing the pulp on the periapical radiograph
  • The tooth should give positive response to cold sensibility testing
  • Clinical diagnosis of symptomatic/asymptomatic irreversible pulpitis based on the symptoms, radiographic findings and results of cold testing
  • The tooth is restorable, probing pocket depth and mobility are within normal limits
  • Periapical radiograph demonstrates the presence of periapical lesion.

You may not qualify if:

  • Non-restorable tooth.
  • Signs of pulpal necrosis including sinus tract or swelling.
  • Evidence of necrotic tissue in one or all canals.
  • Profuse pulpal bleeding and inability to achieve hemostasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Nessrin Taha, DClinDent, PhD

    Jordan University of Science and Technology

    STUDY CHAIR

Central Study Contacts

Nessrin Taha, DclinDent (Endo), PhD

CONTACT

Nessrin Taha, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single-arm, prospective clinical study. All eligible participants will receive the same full pulpotomy treatment protocol, including diode-laser-assisted hemostasis and calcium silicate-based pulp capping. Treatment outcomes will be evaluated clinically and radiographically during follow-up. There is no randomization or concurrent control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2026

First Posted

August 17, 2026

Study Start (Estimated)

October 7, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2030

Last Updated

August 17, 2026

Record last verified: 2026-08