Clinical trial NCT04926883: Comparison Between Sonic Fill and X-tra Fill in Clinical Performance
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SonicFill Clinical Performance
Sonicated Bulk-fill Resin Composite
Keywords: bulk-fill
resin composite
sonicfill
clinical performance
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: change in clinical performance
timeFrame: 1 week, 3 months, 6 months, 12 months
Secondary outcomes:
measure: change in post-operative pain using modified Visual Analogue Scale (VAS)
timeFrame: daily for 1 week
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
References: