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

Minia University30 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

SonicFill Clinical Performance Sonicated Bulk-fill Resin Composite

Interventions

bulk-fill composite resin restorationsOTHER

bulk-fill composite resin restorations up to 5mm layer thickness

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Minia University

Minya, Egypt

Outcomes

Primary Outcomes

change in clinical performance

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).

Time frame: 1 week, 3 months, 6 months, 12 months

Secondary Outcomes

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) from 0 to 10, where 10 means sever pain, for 1 week.

Time frame: daily for 1 week

Data from ClinicalTrials.gov

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