Evaluation of the Clinical Success of Pediatric Fiberglass Crowns in Primary Teeth Using Different Luting Cements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Crown success
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The treatments and evaluations were conducted by different researchers. As a result, masking could be performed for both the investigators and the participants.
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For participants:
- •absence of any systemic disease
- •absence of any periodontal disease
- •no unilateral chewing habit
- •a Frankl scale score of three-four
- •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
排除标准
- •did not attend their follow-up appointments
研究组 & 干预措施
Device: Glass-ionomer cement
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.
干预措施: Tooth Preperation (Procedure)
Device: Glass-ionomer cement
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.
干预措施: Cementation (Procedure)
Device: Resin-modified glass-ionomer cement
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.
干预措施: Tooth Preperation (Procedure)
Device: Resin-modified glass-ionomer cement
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.
干预措施: Cementation (Procedure)
结局指标
主要结局
Crown success
时间窗: 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.
次要结局
- Plaque Index(Evaluations were conducted at the 1st, 3rd, 6th, 12th months.)
- Gingival Index(Evaluations were conducted at the 1st, 3rd, 6th, 12th months.)
研究者
Zulfikar Zahit Ciftci
Head of Principal Dentisty
Akdeniz University