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

Not Applicable

Completed

• Conditions: SonicFill Clinical Performance; Sonicated Bulk-fill Resin Composite
• Interventions: Other: bulk-fill composite resin restorations

• Registration Number: NCT04926883
• Lead Sponsor: Minia University

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).

Study Timeline

• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-15
• Study Start: 2021-07-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-21
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
X-tra fill	bulk-fill composite resin restorations	-
Sonic fill	bulk-fill composite resin restorations	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Minia University; 🇪🇬 Minya, Egypt