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Vertical Dimension Changes After Bioflx vs Stainless Steel Crowns in Primary Molars

ConditionsEarly Childhood CariesDental CariesPulp-Treated Primary Molars
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-9
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bioflx Crown

    Device

    Aesthetic full-coverage pediatric crown used after pulp therapy of primary molars. The Bioflx crown will be selected according to tooth size, adapted following the study protocol, and cemented with resin-modified glass ionomer cement.

  • Stainless Steel Crown

    Device

    Preformed stainless steel full-coverage pediatric crown used after pulp therapy of primary molars. The stainless steel crown will be selected according to tooth size, adapted following the study protocol, and cemented with resin-modified glass ionomer cement

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Bioflx Crown GroupExperimental treatment 1 intervention
Group B: Stainless Steel Crown GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Vertical dimension alterations

Change in inter-occlusal vertical dimension measured in millimetres using a digital caliper at baseline, immediately after crown placement, at 1 week, and at 4 weeks. Mean differences will be compared between the Bioflx crown group and the stainless steel crown group.

Time frame
Baseline, immediately after crown placement, 1 week, and 4 weeks

Secondary outcomes

1

Mean Biting Force Distribution

Occlusal force distribution on the restored tooth measured as a percentage using T-Scan digital occlusal analysis at baseline, immediately after crown placement, at 1 week, and at 4 weeks. Force distribution will be compared between the Bioflx crown group and the stainless steel crown group.

Time frame
Baseline, immediately after crown placement, 1 week, and 4 weeks
2

Parental Satisfaction With Treatment Impact

Parental ratings of the impact of treatment on the child, including comfort, chewing ability, well-being, and perceived improvement in appearance, assessed using a 5-point Likert scale questionnaire.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: