RecruitingNot ApplicableNCT06599814

Comparative Evaluation of the Clinical Outcome of Direct Pulp Capping Treatment in Permanent Molars

Comparative Evaluation of the Clinical Outcome of Direct Pulp Capping Treatment Using Bioactive Materials With Diode Laser in Permanent Molars: a Randomized Clinical Trial


Sponsor

Kafrelsheikh University

Enrollment

120 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial will be performed during June 2024 and December 2024. The study is conducted following the Declaration of Helsinki Ethical principles for medical research involving human subjects after being independently reviewed and approved by the Institution's Ethical Committee and is designed in accordance with CONSORT 2010. Selected patients who are between 19 and 40 years of age had undergone conservative treatment for deep caries management in their permanent teeth in the restorative and endodontic departments, faculty of dentistry, Kafrelsheikh university. The patients are then assigned randomly into four different groups for this randomized clinical study. The decision for direct pulp capping will be made after informing the patients about all the pulp capping procedures that are suggested. Furthermore, any possible complications, postoperative discomfort, or failure of the treatment will be discussed with the patient. All included patients signed a written informed consent before enrollment


Eligibility

Min Age: 19 YearsMax Age: 40 Years

Inclusion Criteria1

  • In all patients, the pulp had been exposed because of caries removal. Data collection included clinical pulp capping respecting the following criteria.

Exclusion Criteria7

  • Individuals who are 19 to 40 years old.
  • Permanent teeth that have not been repaired and have extensive caries on their occlusal and proximal surfaces, extending more than two-thirds of the dentin near the pulp.
  • Vital teeth; asymptomatic teeth (not sensitive to pressure, percussion, or palpation, and no spontaneous pain); sinus tract devoid of swelling and abscess; abnormal mobility absent; no history of spontaneous pain; mild, dull, and tolerable pain associated with eating and drinking cold drinks.
  • Ethyl chloride cold tests, gutta-percha heat testing, palpation, percussion, and the lack of radiological symptoms in periapical radiographs are used to assess the life of the teeth prior to treatment. After the stimulus is removed, pain from a pulp test that is triggered by either heat or cold should subside.
  • In periapical radiography, none of the following conditions should be present: normal lamina dura and periodontal ligaments, no internal or external root resorption, and no radiolucency in the furcation area or periapical region.
  • The exposed area's diameter ranges from 0.5 to 1 mm.
  • Participants' acceptance of the research program.

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Interventions

PROCEDUREvital pulp therapy

vital pulp therapy using two bioactive materials TheraCal and RetroMTA as direct pulp caping materials conventionally and test using Diode laser before application of these materials


Locations(1)

kafrelsheikh University

Kafr ash Shaykh, Kafr El-Shaikh, Egypt

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NCT06599814


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