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Completed

NCT Number: NCT07761897

Composite Restorations in Primary Molars

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

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Key information

Conditions

Restoration Caries Class II Caries; Dentin

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Celebi University

Izmir, Çiğli, 35640, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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 comparison

Other

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.

Primary outcomes

  1. Fédération Dentaire Internationale (FDI) criteria

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

    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

Secondary outcomes

  1. survival comparison

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

    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.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

Clinical Performance of a Preheated Thermoviscous Bulk-Fill Composite and Two Different Indirect Composite Systems in Primary Molars: A Randomized Controlled Trial

Acronym: Composite Rest

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

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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