Evaluating oral hygiene and microbial load after restoring primary molars with different crowns
Evaluation of Oral Hygiene Status in Correlation With Microbial Load in the Oral Cavity Following Restorations of Primary Molars Using Stainless Steel and Bioflex Crowns (Clinical Randomized Trial)
This study is testing how different types of crowns for kids' back teeth affect their oral hygiene and the amount of germs in their mouths.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 4 Years to 8 Years |
| Sex | All |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 2 sites (Cairo, Nasr City and 1 other locations) |
| Trial ID | NCT06767670 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between oral hygiene and microbial load in children aged 4 to 8 years who have undergone restoration of primary molars using stainless steel and bioflex crowns. The study employs a split-mouth technique, comparing the effects of both types of crowns on gingival health and the presence of microorganisms in the oral cavity. Participants will be assessed for their oral hygiene status following the restoration procedure to determine any differences in microbial load associated with the crown type used.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 to 8 years who require full coverage restoration of primary molars and have undergone pulp therapy.
Not a fit: Patients with systemic diseases, physical disabilities, or those with non-restorable teeth will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into improving oral health outcomes in children with restored primary molars.
How similar studies have performed: While similar studies have explored oral hygiene and microbial load, this specific comparison of crown types in a pediatric population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants aged between 4 and 8 years. * Pulp therapy treated primary molars on the contralateral side, requiring a full coverage restoration (split-mouth technique). * No history of any antibiotic consumption 2 weeks before the procedure. * No history of fluoride application 2 weeks before the procedure. Exclusion Criteria: * Special children with physical disabilities or emotional disturbances. * Children are diagnosed with systemic diseases. * Grossly destructed teeth with non-restorable crown structure. * Primary teeth with shedding or pathological tooth mobility.
Where this trial is running
Cairo, Nasr City and 1 other locations
- Al-Azhar University — Cairo, Nasr City, Egypt (Recruiting)
- Faculty of Dental Medicine at Al-Azhar University. — Cairo, Nasr City, Egypt (Not_yet_recruiting)
Study contacts
- Principal investigator: Alaa Mohammed Eldehna, Assistant Proffessor — Al-Azhar University
- Study coordinator: Alaa Mohammed Eldehna, Assistant Proffessor
- Email: alaaaldehna.26@azhar.edu.eg
- Phone: 02001068837641
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.