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Clinical Performance of a Highly-filled Flowable Composite in Class III Restorations.

NCT07051551 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-04

No results posted yet for this study

Summary

The aim of this study was to evaluate the 12-month clinical performance of a highly filled flowable composite resin in anterior teeth.

The study will include healthy individuals over the age of 18 who apply to the Department of Restorative Dentistry, Faculty of Dentistry, Hacettepe University, for the treatment of Class III lesions in their anterior teeth. After explaining the purpose and procedures of the study, participants will be asked to sign an informed consent form if they agree to participate. Gender, age, and the tooth numbers to be treated will be recorded. A total of 100 maxillary anterior incisor teeth in 50 patients will be treated, ensuring a balanced distribution of treated teeth between the right and left arches.

A split-mouth design will be used, whereby at least two teeth per patient will be included in the study, and each of the two restorative materials will be applied to one tooth. The allocation of restorative material to each tooth will be randomized. Before the procedure, the names of both materials will be written on separate papers, placed into envelopes, and a member of the auxiliary staff will randomly select one envelope during the restoration stage to ensure randomization.

The sample size was calculated using the Sealed Envelope software program (Sealed Envelope Ltd., 2012). It was assumed that 95.0% of the restorations would remain intact over 12 months, with α = 0.05, power = 80%, and an expected 10% difference between groups. Based on these parameters, the required sample size was calculated as 33. Considering the possibility of patient dropout during the study, 50 teeth per group were included.

Conditions

  • Dental Caries

Interventions

DEVICE

tooth restoration

restoration of class ııı cavities

DEVICE

tooth restoration

restoration of class ııı cavities

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-12-01
Completion
2026-12-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07051551 on ClinicalTrials.gov