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Comparative Evaluation of Three Pulpotomy Agents for Permanent Mature Molars With Irreversible Pulpitis

Sponsored by Ain Shams University

About this trial

Last updated a year ago

Study ID

FDASU-REC1261

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
16 to 50 Years
All
All

Trial Timing

Started a year ago

What is this trial about?

Statement of the problem: Accurate pulpal diagnosis is essential for decision making between vital pulp therapy and root canal treatment. Clinical and radiographic examinations do not correctly reflect the histological state of the pulp and consequently its ability to heal. Also, despite the various advantages of using MTA as a pulp capping agent, it has several drawbacks. Aim of the study: The aim of the study is to compare two types of calcium silicate-based materials to MTA in permanent mature molars diagnosed with irreversible pulpitis regarding the following parameters; level of inflammatory biomarker level, clinical and radiographic outcomes. Materials and methods: Thirty-six patients with mature permanent molars exhibiting signs and symptoms indicative of irreversible pulpitis will be enrolled. A careful periodontal treatment and standardized operative procedure will be followed for all participants. Gingival crevicular fluid samples will be obtained before any local anesthetics' administration, followed by isolation of teeth with a dental dam and removal of caries. Pulpotomy will be performed using sterile round bur till level of orifices and then haemostasis will be achieved using sodium hypochlorite. At this point, patients will be randomly divided into three groups of 12 depending on the type of calcium silicate-based material used. Later, resin modified glass ionomer will be applied, etching, bonding and placement of composite as the permanent restoration. Follow up clinically and radiographically will be done.

What are the participation requirements?

Yes

Inclusion Criteria

- Participants with permanent molars considered as having clinical signs and symptoms consistent with a diagnosis of irreversible pulpitis if they presented with the following chief complaint:

- Intermittent or spontaneous, sharp or dull, localized, diffuse, or referred pain.

- Rapid exposure to dramatic temperature changes elicited heightened and --prolonged episodes of pain even after the thermal stimulus has been removed.

- Participants without signs and symptoms of apical periodontitis

- Periodontally healthy permanent molars

- Systemically healthy patients without any history of long-acting NSAIDs intake in the past one week will be included to eliminate any confounding factors.

No

Exclusion Criteria

- Non-restorable teeth with cracks or subgingival caries, associated sinus or swelling, immature roots, periapical rarefaction (PAI score ≥ 3).

- Poor periodontal support.

- Negative response to pulp sensibility tests.

- Diabetic, immune-compromised, pregnant patients

- Patient had a positive history of antibiotic use in the past 1 month or required antibiotic prophylaxis

- The tooth was previously accessed

- The tooth had an inflamed pulp in which bleeding could not be controlled within 10 minutes.