Minia University
Minya, Egypt
NCT Number: NCT04926883
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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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Minya, Egypt
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
bulk-fill composite resin restorations up to 5mm layer thickness
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).
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.
Minia University
Other
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.
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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.