Clinical Trials Directory

Trials / Completed

CompletedNCT06558734

Pediatric Fiberglass Crown in Primary Teeth

Evaluation of the Clinical Success of Pediatric Fiberglass Crowns in Primary Teeth Using Different Luting Cements

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
38 (actual)
Sponsor
Akdeniz University · Academic / Other
Sex
All
Age
5 Years – 9 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDURETooth PreperationAfter 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.
PROCEDURECementationFigaro 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.

Timeline

Start date
2020-06-15
Primary completion
2021-11-20
Completion
2022-11-23
First posted
2024-08-19
Last updated
2024-08-19

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06558734. Inclusion in this directory is not an endorsement.