Pediatric Fiberglass Crown in Primary Teeth
- Conditions
- Dental CariesDental Plaque
- Interventions
- Procedure: Tooth PreperationProcedure: Cementation
- Registration Number
- NCT06558734
- Lead Sponsor
- Akdeniz University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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
- did not attend their follow-up appointments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Device: Glass-ionomer cement Cementation The capsule was attached to the mixer and mixed for 10 seconds. The cement was evenly distributed to the crowns paying attention that there were no air voids. Then crowns were placed by pressing them onto the prepared teeth with finger pressure. At least 2 minutes and 15 seconds after mixing, the excess cement was cleaned off. Following mixing, a minimum of 4 minutes and 30 seconds was allowed for the cement to set. Device: Resin-modified glass-ionomer cement Tooth Preperation FujiCEM 2 (GC, Tokyo, Japan) was evenly distributed to the inner surface of the crown with the syringe and immediately placed onto the teeth with finger pressure. The crowns were placed on the prepared tooth. At least 2 minutes and 15 seconds after mixing, the excess cement was cleaned off. Following mixing, a minimum of 4 minutes and 30 seconds was allowed for the cement to set. Device: Resin-modified glass-ionomer cement Cementation FujiCEM 2 (GC, Tokyo, Japan) was evenly distributed to the inner surface of the crown with the syringe and immediately placed onto the teeth with finger pressure. The crowns were placed on the prepared tooth. At least 2 minutes and 15 seconds after mixing, the excess cement was cleaned off. Following mixing, a minimum of 4 minutes and 30 seconds was allowed for the cement to set. Device: Glass-ionomer cement Tooth Preperation The capsule was attached to the mixer and mixed for 10 seconds. The cement was evenly distributed to the crowns paying attention that there were no air voids. Then crowns were placed by pressing them onto the prepared teeth with finger pressure. At least 2 minutes and 15 seconds after mixing, the excess cement was cleaned off. Following mixing, a minimum of 4 minutes and 30 seconds was allowed for the cement to set.
- Primary Outcome Measures
Name Time Method Crown success Evaluations 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 Outcome Measures
Name Time Method Plaque Index Evaluations 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 Index Evaluations 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.
Trial Locations
- Locations (1)
Akdeniz University
🇹🇷Antalya, Turkey