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NCT Number: NCT07768852

Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis

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.

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Key information

Age range

8 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Full Pulpotomy

Procedure

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

Primary outcomes

  1. Success of pulpotomy

    Time frame: 6 and 12 months

    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.

Secondary outcomes

  1. Postoperative pain

    Time frame: 3 and 7 days after treatment

    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.

Other outcomes

  1. Oral health-related quality of life

    Time frame: Before treatment, 1 week and 12 months after treatment

    Oral health-related quality of life will be assessed using the Oral Health Impact Profile questionnaire modified for endodontic treatment.

  2. Tooth Survival

    Time frame: 12, 24, and 36 months

    Tooth survival will be assessed based on percentage of the treated teeth remains present and functional during the follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

Nessrin Taha, DclinDent (Endo), PhD

CONTACT

[email protected]

+962776566110

Nessrin Taha, PhD

CONTACT

[email protected]

+962777258907

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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