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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irreversible Pulpitis With Apical Periodontitis
• Intervention / Treatment: Procedure: Full pulpotomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nessrin Taha, DclinDent (Endo), PhD; Phone Number: +962776566110; Email: n.taha@just.edu.jo
• Study Contact Backup: Name: Nessrin Taha, PhD; Phone Number: +962777258907; Email: nessrin_taha@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis.; 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; 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.; Other Names: Cervical pulpotomy; Coronal pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative pain will be assessed using a numerical rating scale from 0 to 10, where 0 represents no pain and 10 represents the most severe pain.	3 and 7 days after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral health-related quality of life	Oral health-related quality of life will be assessed using the Oral Health Impact Profile questionnaire modified for endodontic treatment.	Before treatment, 1 week and 12 months after treatment
Tooth Survival	Tooth survival will be assessed based on percentage of the treated teeth remains present and functional during the follow-up period.	12, 24, and 36 months

Collaborators and Investigators

• Sponsor: King Abdullah University Hospital
• Investigators: Study Chair: Nessrin Taha, DClinDent, PhD, Jordan University of Science and Technology

Publications and helpful links

Helpful Links

• A review study published by main investigator on managemnt of teeth with carious pulp exposure with variable diagnosis and periapical status.

Study record dates

Study Major Dates

• Study Start (Estimated): October 7, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: August 8, 2026
• First Submitted That Met QC Criteria: August 12, 2026
• First Posted (Actual): August 17, 2026

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Laser; Pulpotomy; Pulpitis; Periapical lesion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Dental Pulp Diseases; Tooth Diseases; Pulpitis
• Other Study ID Numbers: 550/226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will not be shared publicly due to institutional regulations regarding data access and participant confidentiality. Requests for access to study data may be considered by the Principal Investigator following publication of the study results, in accordance with university policies and applicable ethical requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No