NCT07761897 - Composite Restorations in Primary Molars | Crick

Overview

The aim of this study was to compare the clinical performance of direct restorations with two different indirect composite systems in primary teeth.

The aim of this study was to compare the clinical performance of a thermoviscous bulk-fill composite used in direct restorations with two different indirect composite systems in primary teeth. This randomized, controlled, assessor-blind, parallel-group design in vivo study included 158 teeth from 73 patients aged 4-10 years. The teeth were allocated into three groups: direct thermoviscous bulk-fill composite, indirect nano-hybrid composite inlay system, and indirect nano-hybrid modular composite system. Clinical evaluations were performed according to FDI criteria at 6- and 12-month follow-up, and survival comparisons were conducted.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

90

Conditions

Restoration Caries; Dentin Caries Class Ii

Interventions

Fédération Dentaire Internationale (FDI) criteria.OTHER

The clinical performance of restorations was evaluated using Fédération Dentaire Internationale (FDI) criteria. Restorations were assessed across functional (fracture and retention, marginal adaptation), biological (postoperative sensitivity, recurrent caries, tooth integrity, and periodontal response), and esthetic (surface polish, marginal and surface staining) domains using a five-point scale. Scores of 1-3 were considered clinically acceptable, whereas scores of 4-5 were considered clinically unacceptable and indicative of failure

survival comparisonOTHER

For survival comparisons, restoration failure was defined as total or partial loss of the restoration or a clinically unacceptable score according to FDI criteria. Restorations maintaining acceptable clinical performance throughout the follow-up period were considered successful.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * children aged between 4 and 10 years, * classified as ASA I according to the American Society of Anesthesiologists (i.e., healthy individuals without systemic disease except for conditions not affecting general health), * demonstrating cooperative behavior corresponding to Frankl Behavior Rating Scale scores of 3 (positive) or 4 (definitely positive). * Only patients presenting with Angle Class I occlusion * demonstrating bilateral, balanced mastication were included in the study. * Teeth included in the study were required to present with Class II (MO/DO) cavities and to have an antagonist and proximal contact. * According to the International Caries Detection and Assessment System II (ICDAS II), teeth with scores of 4, 5, or 6 were included. * In addition, only teeth with a plaque index score of 0 (no plaque) or 1 (plaque not visible to the naked eye but detectable with a probe at the gingival margin) * a gingival index score of 0 (healthy gingiva, no inflammation) were selected Exclusion Criteria: * patients who do not meet the inclusion criteria * teeth that do not meet the inclusion criteria * Teeth showing internal and external resorption on radiographic examination * Patients/guardians who declined to participate in the study and participants who did not sign the consent form

Locations (1)

Izmir Katip Celebi University

Izmir, Çiğli, Turkey (Türkiye)

Outcomes

Primary Outcomes

Fédération Dentaire Internationale (FDI) criteria

The clinical performance of restorations was evaluated using Fédération Dentaire Internationale (FDI) criteria. Restorations were assessed across functional (fracture and retention, marginal adaptation), biological (postoperative sensitivity, recurrent caries, tooth integrity, and periodontal response), and esthetic (surface polish, marginal and surface staining) domains using a five-point scale. Scores of 1-3 were considered clinically acceptable, whereas scores of 4-5 were considered clinically unacceptable and indicative of failure

Time frame: Clinical evaluations were performed according to FDI criteria at 6- and 12-month follow-up

Secondary Outcomes

survival comparison

For survival comparisons, restoration failure was defined as total or partial loss of the restoration or a clinically unacceptable score according to FDI criteria. Restorations maintaining acceptable clinical performance throughout the follow-up period were considered successful.

Time frame: 6- and 12-month follow-up