Direct Pulp Capping Compared to Partial Pulpotomy in Carious Pulp Exposures

Not Applicable

Active, not recruiting

• Conditions: Deep Caries
• Interventions: Procedure: Direct pulp capping and partial pulpotomy

• Registration Number: NCT06495242
• Lead Sponsor: King Abdullah University Hospital

Brief Summary

This a prospective randomized clinical trial that compare vital pulp therapy procedures in permanent teeth with carious pulp exposure. Patients are recruited from the dental teaching clinics at JUST following preset inclusion criteria. They are subsequently randomly assigned to one of treatment procedures. Clinical and radiographic follow up is performed after 6 months and yearly up to 5 years.

Detailed Description

Background: Deep carious lesions are commonly encountered in both adults and children with no clear consensus on the ideal clinical management. Vital pulp therapy including direct pulp capping and pulpotomy is increasingly considered in the management of carious pulp exposures when the clinical diagnosis is reversible pulpitis with variable reports of success rates with different materials used and different diagnostic categories.

Aims: The aims of this study are to evaluate the clinical and radiographic outcomes of direct pulp capping and partial pulpotomy in deep carious lesions of mature permanent teeth using a calcium silicate based material (Biodentine, Septodont, France), and to investigate the relationship between matrix metalloproteinase (MMP 9) levels in the pulpal blood and the outcome of these procedures.

Methods: 120 mature molar teeth in 120 patients with deep carious lesions exposing the pulps on the radiograph and with symptoms of reversible pulpitis will be included in the study. The teeth will be subsequently randomly divided into 2 groups (n=60). One group will receive direct pulp capping and composite restoration, and the second group will receive partial pulpotomy and composite restoration. Pulpal blood will be collected from the exposure site and will be tested for the level of MMP9 using special ElISA kit. Preoperative and postoperative pain level at 48 hours and 7 days will be evaluated on a scale from 0-10.

The treated teeth will be further evaluated clinically and radiographically at 6 and 12 months follow up and yearly afterward. The relationship of the outcome to the level of MMP9 will be investigated. The results will be statistically analyzed using appropriate tests in the SPSS software.

Expected results: Since partial pulpotomy includes the removal of 2-3 mm of the exposed pulp tissue which is theoretically inflamed, it is expected to be more effective in alleviating the patient's symptoms and to have a higher success rate than simply pulp capping the carious exposure. High levels of MMP9 are also expected to have a correlation with the failure rate.

Study Timeline

• Study Start: 2023-03-25
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-02
• Study First Posted: 2024-07-10
• Primary Completion: 2024-12-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• Study Completion: 2026-12-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Non -contributory medical history (ASA 1)
• Molar tooth with extremely deep caries extending>2/3 of dentin or exposing the pulp on the periapical radiograph
• The tooth should give positive response to cold testing
• Clinical diagnosis of reversible pulpitis with mild to moderate symptoms
• The tooth is restorable, probing pocket depth and mobility are within normal limits
• No signs of pulpal necrosis including sinus tract or swelling
• No radiographic evidence of periapical changes indicative of apical periodontitis

Exclusion Criteria

Immature teeth

• Nonvital teeth
• Irreversible pulpitis and periapical periodontitis, i.e spontaneous and lingering pain.
• Inability to achieve hemostasis after 6 minutes of application of 5% NaOCl moist pellet
• No pulp exposure after nonselective caries removal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct pulp capping	Direct pulp capping and partial pulpotomy	After caries excavation and pulp exposure, the cavity is disinfected . the capping material is applied and the tooth is restored.
Partial pulpotomy	Direct pulp capping and partial pulpotomy	After caries excavation and pulp exposure, 2-3 mm of the exposed pulp are cut . The capping material is applied and the tooth is restored.

Primary Outcome Measures

Name	Time	Method
Short term clinical outcome	one week	Resolution of clinical symptoms

Secondary Outcome Measures

Name	Time	Method
long term outcome	1-5 years	Maintenance of pulp vitality

Trial Locations

Locations (1)

Faculty of Dentistry, Jordan University of Science and Technology; 🇯🇴 Irbid, Jordan