Comparing bioactive and non-bioactive materials for treating deep cavities in molars
Outcome of Bioactive Versus Non-Bioactive System for Restoration of Deep Carious Molars Using Selective Caries Removal Technique: 18 Months Randomized Clinical Trial
This study tests whether using special materials that help teeth heal can work better than regular materials for treating deep cavities in molars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06348953 on ClinicalTrials.gov |
What this trial studies
This research investigates the effectiveness of bioactive versus non-bioactive restorative systems in treating deep carious lesions in permanent molars using selective caries removal techniques. The study aims to preserve healthy tooth structure while effectively eliminating carious tissue. Participants will be randomly assigned to receive either a bioactive or non-bioactive restorative material after selective caries removal, with clinical evaluations conducted over several months to assess restoration integrity and pulpal response. The findings will provide evidence-based insights into the comparative performance of these restorative systems.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 18-40 with deep carious lesions in permanent molars who can tolerate restorative procedures.
Not a fit: Patients with allergies to restorative materials, systemic diseases, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with deep carious lesions, enhancing the longevity and effectiveness of dental restorations.
How similar studies have performed: While bioactive materials have shown promise in other contexts, this specific comparison in deep carious lesions is relatively novel and has limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Faculty of Dentistry - Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: ahmed M adam, Mcs
- Email: ahmed-mohammed@dentistry.cu.edu.eg
- Phone: +201000899267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.