Sonicated Bulk-fill Resin Composite, SonicFill Clinical Performance
Conditions
Keywords
bulk-fill, resin composite, sonicfill, clinical performance
Brief summary
The present study aims to evaluate a 2-years clinical performance of sonic-activated bulk-fill resin composite material (sonic fill) in comparison to conventional bulk-fill resin composite (X-tra fill) as posterior restorations. The null hypothesis is that sonic-activated bulk-fill resin composite restoration shows no difference when compared to conventional bulk-fill resin composite in clinical performance over 2-years evaluations based on clinical assessment.
Detailed description
Restorations will be evaluated 1 week after placement (Baseline - T0), 3 months (T1), 6 months (T2), 1-year (T3) and 2-years (T4) of clinical service by blinded calibrated examiner using modified United States Public Health Service (USPHS) criteria where score A (Alpha) stands for the clinically ideal restoration. Score B (Bravo) is a clinically acceptable situation except for secondary caries. Score C (Charlie) indicates clinically unacceptable restorations that must be replaced. The restorations will also be evaluated using revised FDI criteria with five grades for each criterion; scores 1 to 3 indicated clinically acceptable restorations, and scores 4 and 5 summarized clinically unacceptable situations indicating repair (score 4) or replacement (score 5).
Interventions
OTHERbulk-fill composite resin restorations
bulk-fill composite resin restorations up to 5mm layer thickness
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* They should have an acceptable oral hygiene level. * Presence of at least two posterior carious lesions to be restored with two different types of composite. * The two materials should be used in approximately the same sized lesions or within the same extension. * Age range between 18 and 45 years. * A good likelihood of recall availability.
Exclusion criteria
* Severe or active periodontal or carious disease. * Heavy bruxism or a traumatic occlusion. * Patients with a compromised medical history or had received therapeutic irradiation to the head and neck region. * Alcoholic and smoker patients. * Patients had participated in a clinical trial within 6 months before commencement of this trial. * Patients unable to return for recall appointment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in clinical performance | 1 week, 3 months, 6 months, 12 months | restorations' evaluation for retention, color matching, marginal discoloration, marginal adaptation, secondary caries, surface texture, anatomic form. Score A (Alpha) stands for the clinically ideal restoration. Score B (Bravo) is a clinically acceptable situation except for secondary caries. Score C (Charlie) indicates clinically unacceptable restorations that must be replaced. Also will be scored from 1 to 5 , which 1 to 3 indicated clinically acceptable restorations, and scores 4 and 5 summarized clinically unacceptable situations indicating repair (score 4) or replacement (score 5). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in post-operative pain using modified Visual Analogue Scale (VAS) | daily for 1 week | The patients will be asked to record their pain level on modified Visual Analogue Scale (VAS) from 0 to 10, where 10 means sever pain, for 1 week. |
Countries
Egypt
Outcome results
None listed