Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorFuture University in Egypt
About this trial
The goal of this study is to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer Shofu Flow Plus X F03 compared to nanohybrid resin composite restoration in deep subgingival proximal cavities over a period of 12 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults patients (20-50)
Good oral hygiene (plaque index 0 or 1 )
Patient approving to participate in the study
Absence of parafunctional habits and/or bruxism
Disqualifiers
Patients with known allergic or adverse reaction to the tested materials.
Systematic disease that may affect participation.
Xerostomic patients.
Bad oral hygiene (plaque index 2 or 3 )
Trial design
Design model
Parallel
Treatments tested in this trial
Beautiful Flow Plus X
Other interventionShofu's Beautifil Flow Plus X F03 is an advanced injectable bioactive composite that merges the adaptability of flowable composites with the mechanical properties of hybrid composites
Dentsply Nanohybrid flowable composite
Other interventiona conventional nano hybrid flowable composite
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Bioactive Giomer MaterialActive comparator 1 intervention
Group B: Nanohybrid resin compositeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recurrent caries
* Yes: no evidence of caries continuous along the margin * No: caries evident continuous with the margin of restoration
Time frame
1 week, 6 months and 12 monthsSecondary outcomes
1
Post-operative sensitivity
* No: Absent * Yes: Present
Time frame
1 week, 6 months and 12 months2
Fracture of the restoration
* Restoration is intact and fully retained. * Restoration is partially retained with some portion of the restoration still intact. * Restoration is completely missing
Time frame
1 week, 6 months and 12 months3
Bleeding on probing
* 0 Healthy gums * 1 Bleeding on probing * 2 periodontal problem with bone loss
Time frame
1 week, 6 months and 12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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