Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis | NCT07768852 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 17, 2026

Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis

Outcome, Quality of Life and Patient Satisfaction After Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis: A Prospective Exploratory Clinical Study.

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07768852
Lead Sponsor: King Abdullah University HospitalOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 30Estimated
Last Update Posted: Aug 17, 2026Actual
Start Date: Oct 7, 2026Estimated
Primary Completion Date: Oct 2028Estimated
Completion Date: Oct 2030Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Outcome, Quality of Life and Patient Satisfaction After Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis: A Prospective Exploratory Clinical Study.
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.
Detailed Description

Conditions

The medical conditions and diseases this study investigates.

Irreversible Pulpitis With Apical Periodontitis

Interventions

The treatments and procedures being evaluated in this study.

Full pulpotomy

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Eligibility Criteria: Inclusion Criteria:

• 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.

Exclusion Criteria:

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.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Nessrin Taha, DclinDent (Endo), PhDContact

n.taha@just.edu.jo+962776566110

Locations

Where the study is run and whether each site is currently recruiting.

No locations

There are no locations for this study.

Collaborators

The organizations and people involved in this study.

Lead Sponsor: King Abdullah University HospitalOTHER

Similar Studies

Other registered studies that closely resemble this one.

This is a single-arm, prospective clinical study evaluating the effectiveness of full pulpotomy in mature permanent posterior teeth diagnosed with symptomatic or asymptomatic irreversible pulpitis and associated periapical radiolucency. The study will be conducted at the endodontic postgraduate, with a minimum target of 30 teeth in 30 patients recruited consecutively during the study period.

Eligible teeth will undergo clinical and radiographic assessment, including cold sensibility testing, percussion, palpation, periodontal assessment, and periapical radiography. Following local anesthesia and rubber dam isolation, caries will be completely removed and full pulpotomy will be performed to the level of the root canal orifices. The vitality of the remaining pulp tissue will be assessed clinically. Hemostasis will initially be attempted using sodium hypochlorite-moistened cotton pellets. A 980-nm diode laser will then be applied to the pulp tissue to assist hemostasis. Following adequate hemostasis, a calcium silicate-based pulp capping material will be placed over the pulp stumps, followed by a resin-modified glass ionomer liner and definitive resin composite restoration.

Teeth found to have complete pulpal necrosis or in which adequate hemostasis cannot be achieved will not proceed with the pulpotomy protocol and will receive appropriate endodontic treatment according to the clinical findings.

Clinical and radiographic follow-up will be performed at 6 and 12 months, with additional follow-up planned at 24 and 36 months. Periapical radiographs will be obtained during follow-up, and limited-field CBCT will be obtained immediately after treatment and at 12 months to assess changes in the periapical lesion. Treatment success will be determined based on the absence of clinical signs and symptoms and evidence of resolution or reduction of the periapical lesion. Radiographic healing will be assessed by comparing follow-up images with baseline postoperative images.

Patient-reported outcomes will include postoperative pain, analgesic intake, oral health-related quality of life, and patient satisfaction. Pain will be assessed before treatment and at 3 days and 1 week after treatment. Oral health-related quality of life and patient satisfaction will be assessed before treatment, at 1 week, and at 12 months.

The study will provide clinical and radiographic evidence regarding the feasibility and outcome of full pulpotomy in selected permanent teeth with irreversible pulpitis and periapical radiolucency. It will also assess patient-reported outcomes associated with this treatment approach and explore whether full pulpotomy may represent a less invasive alternative to conventional root canal treatment in appropriately selected cases.