Evaluation of Bioactive Giomer Material Versus Nanohybrid Resin Composite in Deep Marginal Elevation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorCairo University
About this trial
This study will be conducted to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer compared to nanohybrid resin composite restoration in deep subgingival proximal cavities extending below the CEJ over a period of 24 months.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Young and middle aged patients (20-50)
Good or moderate oral hygiene (plaque index 0 or 1 )
Patient approval
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.
Patients with active periodontal disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Beautifil II LS
Other interventionBeautifil II LS is a low shrinkage bioactive giomer resin composite.
Nanohybrid resin composite material
Other interventionNanohybrid resin composite is a type of restorative material that features nano-sized fillers as a main component.
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
Post-operative sensitivity
Restorations will be assessed by testing of irritability of the pulpal nerve on cold, e.g., with dry ice or cold spray, in comparison to the reaction of a contralateral, sound, and unrestored tooth.
Time frame
Baseline (1 week after intervention), 6 months, 12 months and 24 monthsSecondary outcomes
1
Marginal adaptation
Method of restorations assessment will be Tactile using different sized explorers. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
Time frame
Baseline (1 week after intervention), 6 months, 12 months and 24 months2
Occurrence of caries
Method of restorations assessment will be Tactile using different sized explorers. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
Time frame
Baseline (1 week after intervention), 6 months, 12 months and 24 months3
Proximal Contact
Method of restorations assessment will be tactile using unwaxed dental floss to evaluate proximal contact tightness. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
Time frame
Baseline (1 week after intervention), 6 months, 12 months and 24 months4
Plaque Index
The Plaque Index (PI) is a clinical tool used by dentists to assess the presence and severity of dental plaque accumulation on the teeth. It is scored on a scale of 0 to 3: 0: No plaque present. 1. A thin film of plaque visible only with a probe or at the gingival margin. 2. Moderate plaque accumulation visible to the naked eye. 3. Heavy plaque accumulation visible on the tooth surface.
Time frame
Baseline (1 week after intervention), 6 months, 12 months and 24 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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