Bioactive Versus Non-Bioactive Restorative System in Deep Carious Molars

NCT ID: NCT06348953

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-12-31

Brief Summary

This research study delves into the effectiveness of bioactive and non-bioactive restorative systems in deep carious permanent molars treated with selective caries removal. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue. The study investigates how the choice of restorative material influences the outcomes of selective caries removal procedures in deep carious lesions. By assessing factors such as restoration integrity, pulpal response, and long-term success rates, the research seeks to provide evidence-based insights into the comparative performance of bioactive and non-bioactive restorative systems in this clinical context.

Detailed Description

Deep carious lesions in permanent molars present a significant challenge in restorative dentistry. Traditional approaches to caries removal often involve the removal of excessive healthy tooth structure, leading to weakened teeth and potential pulp exposure. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue, offering a conservative alternative to traditional methods. In recent years, bioactive restorative materials have emerged as promising alternatives to conventional non-bioactive materials. Bioactive materials are designed to interact with the biological environment, promoting remineralization and potentially enhancing the longevity of restorations. However, limited evidence exists comparing the efficacy of bioactive and non-bioactive restorative systems in deep carious lesions treated with selective caries removal. This study is designed as a prospective, randomized controlled trial. Patients presenting with deep carious lesions in permanent molars will be randomly allocated to receive either a bioactive or non-bioactive restorative system following selective caries removal. Baseline demographic and clinical data will be recorded for each participant. Clinical evaluations will be conducted at regular intervals over a follow-up period of months. Outcome measures will include restoration integrity (e.g retention, marginal adaptation), pulpal response (e.g., sensitivity, vitality).

Conditions

Dental Caries; Dental Diseases; Deep Caries; Tooth Diseases; Tooth Decay; Teeth; Lesion; Caries; Dentin; Dental Restoration Failure of Marginal Integrity; Tooth Demineralization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Conventional non-bioactive restorative system (Comparator)

deep carious molars restored with conventional resin based restorative system

Group Type: ACTIVE_COMPARATOR

selective caries removal and conventional non-bioactive restorative system

Intervention Type: OTHER

conventional dental restorative adhesive and resin based composite

Bioactive system (Intervention)

deep carious molars restored with bioactive resin based restorative system

Group Type: ACTIVE_COMPARATOR

selective caries removal and bioactive restorative system

Intervention Type: OTHER

bioactive dental restorative resin based system

Interventions

selective caries removal and conventional non-bioactive restorative system

conventional dental restorative adhesive and resin based composite

Intervention Type: OTHER

selective caries removal and bioactive restorative system

bioactive dental restorative resin based system

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• young adult patients (age: 18-40 years) of both genders.
• Able to tolerate necessary restorative procedures.
• Willing to sign the informed consent.
• Accepts the follow-up period.
• Posterior permanent tooth with occlusal proximal deep carious lesion.
• Radiographically (bitewing radiograph) extending to the inner 1/3 of dentine (D3) with a radiopaque layer between the carious lesion and the pulp chamber.
• Sensible teeth according to cold pulp test.

Exclusion Criteria

• Allergy to any restorative materials.
• Patients undergoing orthodontic treatment with fixed appliances.
• Pregnant women.
• Patients with debilitating systemic diseases
• Teeth with previous restorations.
• Spontaneous pain or prolonged pain (more than 15 s) after sensitivity test (cold test), which would indicate irreversible pulpitis.
• Negative sensibility tests, periapical radiolucencies and sensitivity to axial or lateral percussion.
• Mobile teeth, indicating periodontal disease or trauma.
• External or internal resorption.
• Cervical carious lesions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mahmoud Ahmed Mohammed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry - Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

ahmed M adam, Mcs

Role: CONTACT

ahmed-mohammed@dentistry.cu.edu.eg

+201000899267

Facility Contacts

faculty of dentistry

Role: primary

+223642705

Other Identifiers

Bioactive restorative system

Identifier Type: -

Identifier Source: org_study_id