Pediatric Fiberglass Crown in Primary Teeth
NCT Number: NCT06558734
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Caries|Dental Plaque
Interventions: PROCEDURE: Tooth Preperation|PROCEDURE: Cementation
Sponsor: Akdeniz University
Sex: ALL
Age: CHILD
Enrollment: 38
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2020-06-15
Completion Date: 2022-11-23
Locations: Akdeniz University, Antalya, Turkey

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.

Primary Outcome Measures: Crown success, 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., Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Secondary Outcome Measures: Plaque Index, 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., Evaluations were conducted at the 1st, 3rd, 6th, 12th months.|Gingival Index, 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., Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Other Outcome Measures: Parental Satisfaction with fiberglass crown restorations, 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., Evaluations were conducted at the 1st, 3rd, 6th, 12th months.