Comparison of the Clinical Success of Pediatric Zirconia Crowns Applied with Different Luting Cements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Retention Status
研究概览
简要总结
This randomized controlled trial aims to evaluate and compare the clinical outcomes of prefabricated zirconia crowns (PZCs) for primary molars cemented with different luting cements. The main questions to answer are:
Will there be any difference in the clinical success regarding retention among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding periodontal health among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding pulpal survival among the PZCs cemented with different luting cements? Fifty-three children (60 teeth), between 5 and 11 years old enrolled for the study. Researchers will compare the retention status, plaque index (PI), gingival index (GI), and probing depth (PD) scores, and endodontic/periodontal pathology of PZCs.
Participants will:
- visit the clinic 1st,3rd,6th,12th months after the restoration.
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)
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no history of allergies
- •a Frankl scale score of 3 or 4
- •has at least one carious primary molar
- •No percussion or palpation sensitivity
- •No pathological root resorption
- •No abscess and/or fistula
- •No radiolucency at the furcation area
- •No prior pulpal treatment
- •Presence of permanent successor
- •No mobility or periodontal disease
- •Normal position of permanent successor
- •An interproximal decay and/or extensive decay with at least 2 surfaces
- •If present, physiological root resorption no more than one-third of the root
- •Opposing teeth in occlusal contact
- •Normal lamina dura and periodontal space
排除标准
- •congenital and/or developmental defects
- •history of bruxism
- •skeletal and/or dental malocclusion
- •history of trauma
- •infraocclusion
研究组 & 干预措施
Device: Bioactive Cement
BioCem™ (NuSmile, Texas, USA) was evenly distributed to the inner surface of the crown with the syringe and immediately placed onto the teeth. Crowns were stabilized for 20 seconds before applying halogen/LED light (800-1200mW/cm2) (Valo Cordless, Ultradent) to the buccal and lingual/palatal surfaces for three seconds each.
干预措施: Tooth Preperation (Procedure)
Device: Bioactive Cement
BioCem™ (NuSmile, Texas, USA) was evenly distributed to the inner surface of the crown with the syringe and immediately placed onto the teeth. Crowns were stabilized for 20 seconds before applying halogen/LED light (800-1200mW/cm2) (Valo Cordless, Ultradent) to the buccal and lingual/palatal surfaces for three seconds each.
干预措施: Cementation (Procedure)
Device: Resin Cement
The inner surface of the crowns was treated with 'G-Multi Primer' using a brush and subsequently air-dried. The surfaces of the prepared teeth were treated with 37% orthophosphoric acid. The tooth surfaces were rinsed with an air-water spray to remove the acid from the surfaces. After the etching process, the 'G-Premio Bond' was applied to the teeth surfaces with a brush, rubbed for 10 seconds, and then air-dried for five seconds. Then the teeth were exposed to halogen/LED light (800-1200mW/cm2) (Valo Cordless, Ultradent) for 10 seconds. G-CEM Linkforce (GC, USA) resin cement was gently applied to crowns, and then crowns were pressed onto the prepared teeth with finger pressure.
干预措施: Tooth Preperation (Procedure)
Device: Resin Cement
The inner surface of the crowns was treated with 'G-Multi Primer' using a brush and subsequently air-dried. The surfaces of the prepared teeth were treated with 37% orthophosphoric acid. The tooth surfaces were rinsed with an air-water spray to remove the acid from the surfaces. After the etching process, the 'G-Premio Bond' was applied to the teeth surfaces with a brush, rubbed for 10 seconds, and then air-dried for five seconds. Then the teeth were exposed to halogen/LED light (800-1200mW/cm2) (Valo Cordless, Ultradent) for 10 seconds. G-CEM Linkforce (GC, USA) resin cement was gently applied to crowns, and then crowns were pressed onto the prepared teeth with finger pressure.
干预措施: Cementation (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.
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.
干预措施: Cementation (Procedure)
Device: Resin-modified glass-ionomer cement
The cement was placed into the crown with the self-mixing syringe, ensuring no air voids were created. The crowns were then seated onto the teeth with finger pressure.
干预措施: Tooth Preperation (Procedure)
Device: Resin-modified glass-ionomer cement
The cement was placed into the crown with the self-mixing syringe, ensuring no air voids were created. The crowns were then seated onto the teeth with finger pressure.
干预措施: Cementation (Procedure)
结局指标
主要结局
Retention Status
时间窗: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
The clinical success of the crowns regarding the retention status was evaluated as either present or absent based on whether the crown remained on the restored tooth at each follow-up appointment. Crowns that were still in place during the follow-up visit were considered successful in terms of retention, while those that had decemented were considered unsuccessful.
次要结局
- Gingival Index(Evaluations were conducted at the 1st, 3rd, 6th, 12th months.)
- Pulpal Survival(Evaluations were conducted at the 1st, 3rd, 6th, 12th months.)
- Plaque Index(Evaluations were conducted at the 1st, 3rd, 6th, 12th months.)
- Probing Depth(Evaluations were conducted at the 1st, 3rd, 6th, 12th months.)
研究者
Hüseyin Karayılmaz
Proffessor at Pediatric Dentistry
Akdeniz University