Bioactive Versus Non-Bioactive Restorative System in Deep Carious Molars

NCT06348953 | Completed

• 1 other identifier: Bioactive restorative system
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

self-etch adhesive; deep caries in permanent molars; bioactive restorative system; selective caries removal; partial caries removal; selective removal to soft caries; bioactive adhesive; bioactive bond; bioactivity; deep carious molars; rct

Outcome Measures

Primary Outcomes (1)

• Biological properties - Post Operative Hypersensitivity and Vitality-Success rate%-Scoring system:Ordinal1-5

  1. excellent(No hypersensitivity,normal vitality 2. good(Minor hypersensitivity for a limited time,normal vitality 3. satisfactory(Moderate hypersensitivity-Delayed/mild sensitivity;no subjective complaints,no treatment needed 4. unsatisfactory(Intense hypersensitivity-Delayed with minor subjective symptoms-No detectable sensitivity-Intervention necessary but not replacement 5. poor(Intense, acute pulpitis or non-vital tooth-Endodontic treatment is necessary and restoration replacement

  18 months

Secondary Outcomes (6)

• Functional properties - (fracture and retention)

  18 months

• Functional properties - Approximal anatomical form (contact point and contour)

  18 months

• continue Functional properties (Radiographic Examination -when applicable)

  18 months

• continue Functional properties ( marginal adaptation )

  18 months

• Biological properties (Recurrence of caries (CAR), erosion, abfraction- Scoring system Ordinal 1-5)

  18 months

Study Arms (2)

Conventional non-bioactive restorative system (Comparator)

ACTIVE COMPARATOR

deep carious molars restored with conventional resin based restorative system

Other: selective caries removal and conventional non-bioactive restorative system

Bioactive system (Intervention)

ACTIVE COMPARATOR

deep carious molars restored with bioactive resin based restorative system

Other: selective caries removal and bioactive restorative system

Interventions

selective caries removal and conventional non-bioactive restorative system OTHER

conventional dental restorative adhesive and resin based composite

Conventional non-bioactive restorative system (Comparator)

selective caries removal and bioactive restorative system OTHER

bioactive dental restorative resin based system

Bioactive system (Intervention)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries; Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General practitioner

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 5, 2024
• Study Start: June 1, 2024
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

EG (1)