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Pediatric Fiberglass Crown in Primary Teeth

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06558734
Enrollment
38
Registered
2024-08-19
Start date
2020-06-15
Completion date
2022-11-23
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Dental Plaque

Keywords

Fiberglass crown, Glass-ionomer cement, Resin-modified glass-ionomer cement, Primary molar teeth

Brief 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.

Interventions

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.

PROCEDURECementation

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

Akdeniz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The treatments and evaluations were conducted by different researchers. As a result, masking could be performed for both the investigators and the participants.

Eligibility

Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

For participants: * absence of any systemic disease * absence of any periodontal disease * no unilateral chewing habit * a Frankl scale score of three-four For teeth: * no percussion or palpation sensitivity * no malocclusion * no pathological mobility * no pulpal treatment due to caries or other reasons * had sound cervical margins * not hypoplastic or hypocalcified * had opposing functioning teeth * had physiological root resorption not exceeding one-third of the root length * had deep dentin caries with two or more surface that do not contain pulp involvement

Exclusion criteria

* did not attend their follow-up appointments

Design outcomes

Primary

MeasureTime frameDescription
Crown successEvaluations were conducted at the 1st, 3rd, 6th, 12th months.Crown success was categorized as successful if no loss or fractures occurred and unsuccessful otherwise. Failed cases are classified as decementation, occlusal wear and fracture. Fracture classification includes large loss and chipped cases.

Secondary

MeasureTime frameDescription
Plaque IndexEvaluations were conducted at the 1st, 3rd, 6th, 12th months.The Plaque Index scores of all teeth, including those treated with crowns (FGC group) and their symmetrical, healthy counterparts (control group), were evaluated and recorded, both before and after the application of the fiberglass crowns. The plaque Index was evaluated using the criteria established by Silness and Löe, with scores assigned as follows; 0 (the best): no plaque, 1: a film of plaque adhering to the free gingival margin and adjacent area of the tooth, 2: moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye and, 4 (the worst): abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. In the evaluation of the periodontal index, plaque control was carried out by utilizing a plaque-disclosing agent.
Gingival IndexEvaluations were conducted at the 1st, 3rd, 6th, 12th months.The Gingival Index scores of all teeth, including those treated with crowns (FGC group) and their symmetrical, healthy counterparts (control group), were evaluated and recorded, both before and after the application of the fiberglass crowns. The Gingival Index was evaluated using the criteria established by Silness and Löe, with scores assigned as follows; 0 (the best): normal gingiva, 1: mild inflammation, 2: moderate inflammation, and 4 (the worst): severe inflammation.

Other

MeasureTime frameDescription
Parental Satisfaction with fiberglass crown restorationsEvaluations were conducted at the 1st, 3rd, 6th, 12th months.Parental satisfaction was assessed for appearance, color, shape, size, and durability according to Roberts et al.'s criteria. A 1-5 scale was used with 1=very dissatisfied and 5=very satisfied.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026