Comparing two materials for filling cavities in children's molars
"Evaluation of Clinical Performance of a Flowable Bulk Fill Composite Resin Versus a Highly Viscous Glass Ionomer Cement in Class II Cavities in 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 four to eight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 4 Years to 8 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06235489 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical performance of two restorative materials, EQUIA Forte (a highly viscous glass ionomer) and Plafique Bulk Flow composite resin, in treating class II cavities in primary molars of children aged four to eight. Participants will undergo thorough diagnosis and pre-operative radiographs to assess cavity depth before being assigned to one of the two treatment groups. The effectiveness of the restorations will be monitored at 3, 6, and 12 months post-treatment using established clinical criteria. Additionally, patients will receive oral health education and supplies to promote proper dental hygiene.
Who should consider this trial
Good fit: Ideal candidates are children aged four to eight with active proximal caries in primary molars.
Not a fit: Patients whose parents refuse to sign informed consent or who have specific dental conditions like deep bite or malocclusion may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for dental caries in young children, enhancing their oral health outcomes.
How similar studies have performed: Previous studies have shown varying success with similar restorative materials, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Four to 8 years old children * Cooperative children classified as class 3 or 4 based on Frankle et al. classification. * Presence of deep bite or any type of malocclusion or parafunctional habits. * Children who have at least one primary molar with active proximal caries (score 4 or 5 using ICDAS). Exclusion Criteria: * Refusal of the parents to sign the informed consent. * Presence of deep bite or any type of malocclusion or parafunctional habits.
Where this trial is running
Cairo
- Faculty of Dentistry, Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mariam M Abdel Azim, Ass. Lec
- Email: mariam.m.abdelazim@dent.asu.edu.eg
- Phone: 0122841611
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.