Comparing two materials for filling cavities in children's back teeth
Clinical Performance of a Flowable Bulk Fill Composite Versus a Highly Viscous Glass-ionomer Cement in Restoring Class II Cavities of Primary Molars: A Randomized Clinical Trial
NA · Ain Shams University · NCT06166160
This study tests which filling material, EQUIA Forte or SDR® flow+, works better for treating cavities in the back teeth of kids aged 4 to 8.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 4 Years to 8 Years |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT06166160 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical performance of two different materials, EQUIA Forte and SDR® flow+, used to fill cavities in primary molars of children aged 4 to 8. The research involves taking initial radiographs, performing caries excavation, and restoring cavities with either material according to specific protocols. The goal is to determine which material provides better outcomes in managing dental caries in young patients.
Who should consider this trial
Good fit: Ideal candidates for this study are medically healthy children aged 4 to 8 who have active dentinal carious lesions on their primary molars.
Not a fit: Patients with deep bite, malocclusion, or those whose parents refuse to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dental treatment options for children with cavities, enhancing their oral health and comfort.
How similar studies have performed: Previous studies have shown varying success with similar materials in dental restorations, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 4 to 8 years old medically free children. 2. Cooperative children are classified as class 3 or 4 based on Frankel et al. classification. 3. Children who had at least one active dentinal carious lesion on the proximal surface of primary molars Exclusion Criteria: 1. Refusal of the parents to sign the informed consent 2. Presence of deep bite or any pictures of malocclusion and parafunctional habits.
Where this trial is running
Cairo and 1 other locations
- Faculty of dentistry .Ain shams university — Cairo, Egypt (RECRUITING)
- Marina Fakhry Fahmy — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: Marina F Fahmy, ass.lecturer — assistant lecturer of pediatric dentistry ,faculty of dentistry ASU
- Study coordinator: Marina F Fahmy, MD
- Email: Dr.marina.fakhry@gmail.com
- Phone: 01273731722
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.
Conditions: Management of Dental Caries of Primary Molars, bulk-fill flowable composite , high viscous GIC ,