An interventional study of Full pulpotomy in Irreversible Pulpitis With Apical Periodontitis, sponsored by King Abdullah University Hospital. Not yet recruiting. Open to participants aged 8 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by King Abdullah University Hospital · Not applicable, Interventional, and Treatment
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.
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.
316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.
This study's planned enrollment of 30 is below the median of 64 across 288 interventional studies indexed under Pulpitis.
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Non -contributory medical history (SAI, II).
Exclusion Criteria:
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.
Also known as: Cervical pulpotomy, Coronal pulpotomy
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.
Time frame: 6 and 12 months
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.
Time frame: 3 and 7 days after treatment
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.
Time frame: 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.
Time frame: 12, 24, and 36 months
No study locations are listed for this record.
Plan to share: Undecided — 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.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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King Abdullah University Hospital