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Clinical Evaluation of Bulk-fill Restorative Materials

Clinical Evaluation of High-viscosity Glass-hybrid Systems Compared With a Bulk Fill Composite Resin in Different Cavity Type

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06109987
Enrollment
160
Registered
2023-10-31
Start date
2021-10-11
Completion date
2023-09-17
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries; Dentin

Brief summary

High-viscosity glass ionomer cements have been developed to improve the weak mechanical properties of glass ionomer cements, increase wear resistance and improve their limited indications. There are limited clinical studies on the use of high-viscosity glass ionomer cements in areas with large cavities bearing stress. The aim of this study is to compare the clinical performance of two different high-viscosity glass ionomer cements with a bulk-fill resin composite in different cavities.

Detailed description

This study was a double-blind (evaluator and patient) randomized controlled clinical study with three study groups with an equal allocation. Three different restorative materials were compared in Class I, II, and V restorations. The treated patients were called back for controls after one week, six months, and eighteen months. Restorations were evaluated clinically according to modified FDI criteria. In terms of marginal discoloration, fracture and retention, marginal adaptation, post-operative sensitivity, secondary caries, color match and difference criteria were examined. Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 18-month to evaluate the formation of secondary caries. Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using Wilcoxon Signed rank test (p \< 0.05).

Interventions

Restorations were evaluated with FDI criteria.

Sponsors

Recep Tayyip Erdogan University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Voluntarily agreed to participate in the study after being informed about the study. * Volunteer must not be under 18 years of age * No systemic disease * Having healthy oral hygiene * As a result of clinical and radiographic examination, there is a carious lesion at D1 and D2 levels according to the caries classification method. * The tooth to be restored is vital

Exclusion criteria

* Refusal to participate in the study after being informed about the study * The patient has a history of teeth grinding * Volunteer must be under 18 years of age * The volunteer is undergoing or will begin orthodontic treatment * The volunteer has a serious systemic disease * The tooth to be restored has endodontic and periodontal problems * Volunteer's pregnancy status * Extraction of one of the teeth opposite or in contact with the tooth to be restored

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of different restorative materialsBaselineRestored teeth were evaluated according to FDI criteria.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026