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OpenTrials
Completed

NCT Number: NCT04926883

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

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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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University

Minya, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bulk-fill composite resin restorations

Other

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

Primary outcomes

  1. change in clinical performance

    Time frame: 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 outcomes

  1. change in post-operative pain using modified Visual Analogue Scale (VAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2021
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.