Composite Restorations in Primary Molars

NCT07761897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-12

No results posted yet for this study

Summary

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

Conditions

  • Restoration
  • Caries; Dentin
  • Caries Class Ii

Interventions

OTHER

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

OTHER

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.

Sponsors & Collaborators

  • Izmir Katip Celebi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-01-15
Completion
2025-01-15

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 NCT07761897 on ClinicalTrials.gov