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

NCT06232941 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-01-31

No results posted yet for this study

Summary

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.

Conditions

  • Vital Pulp Therapy

Interventions

PROCEDURE

Full pulpotomy procedure

vital pulp therapy for molars with irreversible pulpitis instead of doing root canal treatment

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-12-01
Completion
2025-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06232941 on ClinicalTrials.gov