Comparing two materials for filling cavities in children's teeth

Clinical Performance of a Flowable Giomer Versus a Highly Viscous Glass-ionomer Cement in Restoring Class II Cavities of Primary Molars: A Randomized Clinical Trial

This study is testing which of two materials works better for filling cavities in the back teeth of kids aged 4 to 8.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 4 Years to 8 Years
• Sex: All
• Sponsor: Ain Shams University (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT06000085 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of two restorative materials, Flowable Giomer Beautifil Flow Plus X and Equia Forte, in treating Class II cavities in primary molars of children aged 4 to 8 years. The study will be conducted as a double-blinded, randomized controlled trial, comparing the clinical performance of these materials over a period of 12 months. Participants will be children with active dentinal carious lesions, and the outcomes will be assessed at 3, 6, and 12 months post-treatment. Ethical considerations include informed consent from guardians and assent from children, ensuring confidentiality and the right to withdraw from the study.

Who should consider this trial

Good fit: Ideal candidates for this study are medically healthy children aged 4 to 8 years with active proximal carious lesions in their primary molars.

Not a fit: Patients with deep bites, malocclusions, 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 restoration techniques for children, enhancing the longevity and effectiveness of cavity treatments.

How similar studies have performed: Previous studies have shown varying success rates for similar restorative materials, indicating that this approach has been tested but may still yield novel insights.

Eligibility criteria

Inclusion Criteria:

inclusion criteria of study participants:

1. 4 to 8 years old medically free children.
2. Cooperative children classified as class 3 or 4 based on Frankel et al. classification
3. Children who had at least one active dentinal carious lesion on proximal surface of primary molars

inclusion criteria of teeth:

1. Primary molars with active dentinal carious lesion on their proximal surface score 4, 5 using ICDAS.
2. Primary molars with proximal carious lesion extended to outer and middle third of dentin scored D1and D2 that will be detected by bitewing radiograph.
3. Simple or compound class II cavities be present
4. The antagonist and the adjacent tooth should be present
5. Primary molar should have at least 2/3 of the root present

Exclusion Criteria:

exclusion criteria of study participants

1. Refusal of the parents to sign the informed consent
2. Presence of deep bite or any pictures of malocclusion and any parafunctional habits.

exclusion criteria of teeth

1. Presence of any unprovoked pain, pulp exposure,clinical swelling, abscess or fistula.
2. Presence of any physiological or pathological mobility.
3. Very deep subgingival cavities
4. Teeth with congenitally missing successor

Where this trial is running

Cairo

• Faculty of dentistry ain shams university — Cairo, Egypt (Recruiting)

Study contacts

• Principal investigator: Sarah Emad — faculty of dentistry ain shams university
• Study coordinator: Sarah Emad

Conditions Dental Caries Class II; proximal caries; primary molars; flowable giomer; equia forte