Clinical Performance and Acceptance of Bioflx Crowns
ConditionCaries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorHams Hamed Abdelrahman
About this trial
Treating pediatric patients with early childhood caries can be challenging. For clinicians, managing a young child while ensuring high-quality treatment is difficult. It is essential to have the best equipment and materials available. Today, aesthetics are crucial in managing decayed teeth, with zirconia crowns often preferred for their visual appeal, although they require substantial preparation. The newly developed Bioflx crown, combining stainless steel and zirconia properties, offers an alternative solution.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A child with primary molars is indicated for full coverage.
Disqualifiers
Children with any systemic disease
Clinical or radiographic signs/symptoms of irreversible pulpitis as abscess, fistula, spontaneous pain, mobility, furcation involvement, internal or external root resorption
Children cooperation (1,2) according to Frankl scale
Parents are unwilling to enroll their children in study
Trial design
Design model
Parallel
Treatments tested in this trial
Bioflex Crowns
Other interventionA preformed crown of similar size will be selected. Tooth preparation will be done using a tapered diamond bur to reduce the occlusal surface, including the central groove, by 1-1.5 mm. The proximal surfaces will be prepared by approximately 0.5 mm to clear the contact area.
Stainless steel crown
Other interventionAn appropriately sized preformed stainless-steel crown will be selected. Tooth preparation will involve using a tapered bur ) to reduce the occlusal surface by 1 to 1.5 mm, with interproximal reduction made on the mesial and distal sides. The selected crown size will be checked, and a trial fit will be conducted prior to cementation. Crimping pliers will be used, and the crown will be cemented with Type 1 glass ionomer cement. Any excess cement will be removed, and proper occlusion will be verified.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: BioflexExperimental treatment 1 intervention
Group B: SSCActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in clinical success
The crowns were evaluated clinically according to the following criteria: 1. Length: the margin is at the gingival crest or is extended to the cemento-enamel junction. 2. Position: crown is not rotated. 3. Polish: no scratches or roughness. 4. Cement: no excess cement remains in the sulcus. If all criteria fulfilled the crown is considered acceptable clinically, if not it is considered unacceptable.
Time frame
baseline, 6 months, and 12 months2
parental satisfaction
The questionnaire for assessing parental satisfaction includes four main categories for rating the aesthetic characteristics: size, shape, color, and stain. Responses will be recorded on a five-point Likert scale, ranging from 1 (not at all satisfied) to 5 (very satisfied).
Time frame
through study completion, an average of 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hams Hamed Abdelrahman
Lead sponsor
Alexandria University
Sponsor institution
Source ClinicalTrials.gov