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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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07768852
Enrollment
30
Registered
2026-08-17
Start date
2026-10-07
Completion date
2030-10-01
Last updated
2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis With Apical Periodontitis

Keywords

Pulpitis, Periapical lesion, Pulpotomy, Laser

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

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.

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.

Sponsors

King Abdullah University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
8 Years to 30 Years
Healthy volunteers
Yes

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 outcomes

Primary

MeasureTime frameDescription
Success of pulpotomy6 and 12 monthsTreatment 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

MeasureTime frameDescription
Postoperative pain3 and 7 days after treatmentPostoperative 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.

Contacts

CONTACTNessrin Taha, DclinDent (Endo), PhD
n.taha@just.edu.jo+962776566110
CONTACTNessrin Taha, PhD
nessrin_taha@yahoo.com+962777258907
STUDY_CHAIRNessrin Taha, DClinDent, PhD

Jordan University of Science and Technology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026