Vertical Dimension Changes After Bioflx vs Stainless Steel Crowns in Primary Molars
Starting soon · Not applicable
Conditions studied: Early Childhood Caries, Dental Caries, Pulp-Treated Primary Molars
In brief
this randomized controlled trial will compare Bioflx crowns and stainless-steel crowns in children with pulp-treated primary molars. The study will evaluate changes in vertical dimension and mean biting force after crown placement and will also assess parental satisfaction with esthetics and treatment impact. Eligible children aged 6 to 9 years will be randomly assigned in a 1:1 ratio to receive either a Bioflx crown or a stainless-steel crown. Measurements will be taken at baseline, immediately after crown placement, at 1 week, and at 4 weeks.
Key facts
- Study ID
- NCT07523776
- Run by
- Cairo University
- People needed
- 18
- Starts
- 2026-04-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 6 and older, up to 9. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pulp-treated primary molars (pulpotomy)
- Asymptomatic teeth after pulp therapy with no signs of infection, mobility, or radiographic pathology, such as internal resorption or periapical lesions
- Age 6 years to 9 years
- Male or female
- Cooperative child with positive Frankl behavior rating
- No missing teeth
- Normal occlusion, including normal overjet and overbite
- Free from systemic disease to allow continuity of follow-up
You may not qualify if…
- Medically compromised or uncooperative children
- Tooth indicated for extraction because of root resorption, teeth near exfoliation, or deep subgingival caries that prevents proper coronal seal
- Teeth with more than two-thirds root resorption
- Previous pulp therapy
- Parafunctional habits, including bruxism, thumb-sucking, or other habits that may affect occlusal force measurements
- Inability to attend follow-up visits or parental refusal to participate
Where it is running
- Cairo University — Cairo, Giza/Egypt, Egypt
Full record on ClinicalTrials.gov
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