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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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SonicFill Clinical Performance Sonicated Bulk-fill Resin Composite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sonic fill

Group Type ACTIVE_COMPARATOR

bulk-fill composite resin restorations

Intervention Type OTHER

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

X-tra fill

Group Type ACTIVE_COMPARATOR

bulk-fill composite resin restorations

Intervention Type OTHER

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

Interventions

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bulk-fill composite resin restorations

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

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes