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Pediatric Fiberglass Crown in Primary Teeth

NCT06558734 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-08-19

No results posted yet for this study

Summary

This randomized controlled clinical trial aims to evaluate the clinical success of fiberglass crowns applied to primary teeth and to assess the impact of two different luting cements on the success of the fiberglass crowns. The main questions to answer are:

* Will fiberglass crowns demonstrate sufficient clinical success to serve as a viable alternative to existing pediatric crowns?
* Will there be any differences in the clinical success and mechanical properties of fiberglass crowns based on the type of luting cement used?

Thirty-eight children (60 teeth), between 5 and 9 years old (7.03±1.14), enrolled for the study. The researchers evaluated the clinical success of fiberglass crowns bonded with two different types of luting cement (1: FujiOne; 2: FujiCEM 2) based on retention, anatomical integrity, effect on periodontal health and parental satisfaction.

Participants will:

-Visit the clinic 1st, 3rd, 6th, 12th months after cementatiton.

Conditions

  • Dental Caries
  • Dental Plaque

Interventions

PROCEDURE

Tooth Preperation

After the caries were removed, the teeth were prepared according to the manufacturer's recommendations for Figaro Crowns. Fiberglass crowns (Figaro Crowns Inc., USA) of the most suitable size in terms of the mesio-distal dimension of the tooth were selected. Following the establishment of anesthesia, the teeth were prepared using diamond cutting burs with a high-speed, water-cooled turbine handpiece. In order to achieve adequate interocclusal space, an occlusal reduction of 1-2 mm was executed along with a proximal reduction reaching 1 mm below the gingival margin. A more conservative reduction was applied to the buccal and lingual surfaces. After preparation, any remaining decayed dentin tissue was removed using a steel round bur with a low-speed micromotor. To ensure occlusal harmony, diamond burs were used to perform abrasion on the crown edges, and the trimmed crown edges were polished using rubber aids before cementation.

PROCEDURE

Cementation

Figaro crowns were placed on the prepared teeth with finger pressure, following the manufacturer's instructions for the luting cement to be used. For each cement, the recommended setting time was observed, and excess cement residues were removed accordingly.

Sponsors & Collaborators

  • Akdeniz University

    lead OTHER

Principal Investigators

  • Zulfikar Zahit Ciftci, Phd · Akdeniz University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2021-11-20
Completion
2022-11-23

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 NCT06558734 on ClinicalTrials.gov