Direct Pulp Capping Compared to Partial Pulpotomy in Carious Pulp Exposures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-25

Study Completion Date

2026-12-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Deep Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel randomized clinical trial including 2 treatment groups with 1;1 allocation ration

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

the participants are blinded to the type of treatment provided, the care provider is masked only during the early stages of teh procedure but subsequently masking is not possible due to different treatment protocols.

Block randomization. and sealed envelop technique are used. Principal investigator and evaluator are blinded to the type of treatment provided

Study Groups

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Direct pulp capping

After caries excavation and pulp exposure, the cavity is disinfected . the capping material is applied and the tooth is restored.

Group Type ACTIVE_COMPARATOR

Direct pulp capping and partial pulpotomy

Intervention Type PROCEDURE

Two types of vital pulp therapy procedures

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.

Group Type ACTIVE_COMPARATOR

Direct pulp capping and partial pulpotomy

Intervention Type PROCEDURE

Two types of vital pulp therapy procedures

Interventions

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Direct pulp capping and partial pulpotomy

Two types of vital pulp therapy procedures

Intervention Type PROCEDURE

Other Intervention Names

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Partial pulpotomy

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes