Comparison Between Sonic Fill and X-tra Fill in Clinical Performance

Study Overview
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Brief Summary
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The present study aims to evaluate a 1-year 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 1-year evaluations based on clinical assessment.

Official Title
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Clinical Performance of Sonic-Activated High Viscosity Bulk-Fill Resin Composite in Comparison to Conventional Bulk-Fill Resin Composite Restorations in Posterior Teeth: A Randomized Controlled Clinical Study.

Conditions
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SonicFill Clinical Performance, Sonicated Bulk-fill Resin Composite

Intervention / Treatment
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* Other: bulk-fill composite resin restorations


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sonic fill<br> | Other: bulk-fill composite resin restorations<br>* bulk-fill composite resin restorations up to 5mm layer thickness<br>|
| Active Comparator: X-tra fill<br> | Other: bulk-fill composite resin restorations<br>* bulk-fill composite resin restorations up to 5mm layer thickness<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in clinical performance according to (USPHS) criteria | restorations' evaluation using modified United States Public Health Service (USPHS) criteria 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. | 1 week, 3 months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in post-operative pain using modified Visual Analogue Scale (VAS) | The patients will be asked to record their pain level on modified Visual Analogue Scale (VAS) for 1 week. | daily for 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bulk-fill, resin composite, sonicfill, clinical performance