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OpenTrials
Completed

NCT Number: NCT05559333

CLINICAL COMPARISON OF DIFFERENT GLASS IONOMER-BASED RESTORATIVES AND A BULK-FILL RESIN COMPOSITE IN CLASS I CAVITIES: A 48-MONTH RANDOMIZED SPLIT-MOUTH CONTROLLED TRIAL

The aim of this study is to compare the clinical performances of high-viscosity glass ionomer (GI), glass carbomer (GC), zirconia-reinforced GI (ZIR), and bulk-fill (BF) composite resin restorations.For this purpose, two calibrated operators placed 128 restorations in 30 patients with a mean age of 21 years. The restorations will be evaluated by one examiner at baseline and at 6, 12, 18,24, and 48 months using the modified US Public Health Service criteria. The data will statistically analyzed.

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Key information

Conditions

Class I Dental Caries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Altındağ, 06230, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients presenting 1) at least four single-surface occlusal caries on their posterior molar teeth (first and/or second molars); 2) teeth to be restored had to be vital and without pulpal or periodontal disease, pain, and preoperative sensitivity; 3) teeth should be in occlusion; and 4) must agree to come to follow-up appointments.

Exclusion criteria

  • patients with 1) poor oral hygiene, serious health problems, and/or heavy bruxism; 2) partly erupted teeth; 3) absence of adjacent and antagonist teeth; 4) teeth with interproximal caries; and 5) inability to attend recalls.

Treatment and study plan

class I restoration placement

Procedure

zirconomer, glass carbomer, glass ionomer and composite resin class I restorations were placed.

Primary outcomes

  1. Retention Alpha for at least 90% of the restorations

    Time frame: 24 months

    The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assesed as alpha (retentive restoratation) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.

Secondary outcomes

  1. marginal adaptation score alpha

    Time frame: 24 months

    It represents the marginal integrity of the restorations. It is scored as alpha (perfect marginal adaptation), bravo (detectable marginal discrepency, clinically acceptable) or charlie (marginal crevice, clinically unacceptable). The examination of marginal adaptation is performed by clinical examination of the restoration with probe.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2022
First posted
Sep 29, 2022
Registry last updated
Sep 29, 2022

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.

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