Evaluating a new type of dental filling material for cavities

Performance of GIOMER Based Resin Composite Restorations Versus Conventional Nanohybrid Resin Composite Restorations in Complex Proximal Carious Cavities in Posterior Teeth. (A 24-month Randomized Clinical Trial)

This study is testing a new type of dental filling material to see if it works better than traditional fillings for treating cavities in adults aged 18 to 50.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Cairo University (Academic / other)
• Locations: 1 site (Cairo, Nasr City)
• Trial ID: NCT06021028 on ClinicalTrials.gov

What this trial studies

This study aims to clinically assess the performance of GIOMER based resin composite restorations compared to conventional nanohybrid resin composite restorations in treating complex proximal carious cavities in posterior teeth over a two-year follow-up period. The research will involve patients aged 18 to 50 with specific inclusion criteria related to their dental health and hygiene. The study will test the hypothesis that there is no significant difference in the clinical performance of the two types of restorations. The GIOMER material is designed to release and recharge fluoride and other ions, potentially offering enhanced benefits over traditional materials.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 18 to 50 with proximal carious cavities in molars and good oral hygiene.

Not a fit: Patients with severe medical complications, poor oral hygiene, or those requiring indirect restorations will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved dental restoration options that enhance patient outcomes and reduce the risk of future cavities.

How similar studies have performed: Previous studies have shown comparable success with GIOMER based materials, indicating potential for similar outcomes in this trial.

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria of participants:

1. Patients with proximal carious cavities in molars.
2. 18 - 50 years.
3. Males or Females.
4. Good oral hygiene.
5. Co-operative patients approving to participate in the study.

Inclusion Criteria of teeth:

1. Pulp asymptomatic vital carious complex class II upper or lower posterior teeth.
2. The presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

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   Exclusion Criteria:
   * Exclusion criteria of participants:

   Poor oral hygiene. Severe medical complications. Pregnancy. Allergic history concerning methacrylates Heavy smoking. Xerostomia. Lack of compliance. Evidence of parafunctional habits Temporomandibular joint disorders.

   Exclusion criteria of the teeth:

   Teeth involving more than three surfaces and indicated for indirect restorations.

   Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. Severe periodontal problems.

Where this trial is running

Cairo, Nasr City

• Mohamed Mohamed sabry Mohamed — Cairo, Nasr City, Egypt (Recruiting)

Study contacts

• Principal investigator: Rawda Hesham Abd ElAziz, Phd — Cairo University
• Study coordinator: Rawda Hesham Abd ElAziz, Phd

Conditions Dental Caries