Clinical Evaluation of Contemporary Ion Releasing Restorative Materials in Primary Molars Subjected to Selective Caries Removal: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Clinical evaluation of the filling materials according to the modified USPHS criteria
研究概览
简要总结
This randomized controlled trial aims to compare the clinical effectiveness of four ion-releasing restorative materials in the proximal cavities of primary molars that underwent selective caries removal. The main questions to answer are:
- Will there be any difference among the restorative materials clinical succes in the means of modified United States Public Health Services (USPHS) criteria for dental restorations?
- Will there be any difference among the restorative materials in the means of preservation of pulpal vitality? Eighty six children (262 teeth), between 5 and 9 years old (7.15±1.14) enrolled for the study. Researchers will compare the clinical performance of restorative materials, (1:Equia Forte HT; 2: Fuji II LC; 3: Cention N; 4: ChemFil Rock), applied to the proximal cavities of primary molars following selective caries removal, according to the modified USPHS criteria.
Participants will:
- visit the clinic 1st,3rd,6th,12th,18th,24th,30th and 36th 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)
盲法说明
The materials were visually different from each other, which allowed the investigators to identify each material. As a result, masking could only be performed with 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:
- •no known or suspected history of allergy to medications or restorative materials
- •no habits of teeth grinding or clenching
- •presence of at least one interproximal carious lesion
- •carious lesion reaching at least 1/2 dentin
- •in contact with adjacent teeth and in occlusion with antagonist teeth
- •have no pathological mobility
- •periodontally healthy
- •no symptoms of pulpal pathology
- •physiological root resorption should not exceed one-third of the root length if seen
- •permanent tooth germ present below the tooth
排除标准
- •did not attend their follow-up appointments
研究组 & 干预措施
Device: Hybrid Glass-ionomer Cement (Equia Forte HT)
The material in capsule form was placed in the mixer (Ultramat 2, SDI, Australia) and mixed for 10 seconds, and applied to the cavity in a single step. The restorative material was polymerized for 20 seconds using an LED light device (VALO, Ultradent, Utah, USA). Equia Forte Coat was applied and polymerized for 20 seconds.
干预措施: Caries Removal (Procedure)
Device: Hybrid Glass-ionomer Cement (Equia Forte HT)
The material in capsule form was placed in the mixer (Ultramat 2, SDI, Australia) and mixed for 10 seconds, and applied to the cavity in a single step. The restorative material was polymerized for 20 seconds using an LED light device (VALO, Ultradent, Utah, USA). Equia Forte Coat was applied and polymerized for 20 seconds.
干预措施: Filling (Procedure)
Device: Bioactive Glass-Containing Alkasite (Cention N)
The material was mixed using a plastic spatula on a mixing pad or glass with a powder-to-liquid ratio of 1:1 until it reached a homogeneous consistency, which took approximately 45 -60 seconds. Then the material was applied to the cavity and allowed to set for its self-curing time of 4 and a half minutes.
干预措施: Filling (Procedure)
Device: Resin-Modified Glass-ionomer Cement (Fuji II LC)
The material in capsule form was mixed in the mixer (Ultramat 2, SDI, Australia) for 10 seconds, and applied to the cavity in a single step. Polymerization was achieved using an LED light device (VALO, Ultradent, Utah, USA) for 20 seconds.
干预措施: Caries Removal (Procedure)
Device: Resin-Modified Glass-ionomer Cement (Fuji II LC)
The material in capsule form was mixed in the mixer (Ultramat 2, SDI, Australia) for 10 seconds, and applied to the cavity in a single step. Polymerization was achieved using an LED light device (VALO, Ultradent, Utah, USA) for 20 seconds.
干预措施: Filling (Procedure)
Device: Bioactive Glass-Containing Alkasite (Cention N)
The material was mixed using a plastic spatula on a mixing pad or glass with a powder-to-liquid ratio of 1:1 until it reached a homogeneous consistency, which took approximately 45 -60 seconds. Then the material was applied to the cavity and allowed to set for its self-curing time of 4 and a half minutes.
干预措施: Caries Removal (Procedure)
Device: Zinc-Reinforced High-Viscosity Glass-ionomer Cement (ChemFil Rock)
The material in capsule form was placed in the mixer (Ultramat 2, SDI, Australia) and mixed for 12 seconds, and applied to the cavity in a single step. In addition to the 90-second working time, an additional 4 and a half minutes were allowed for the material to cure.
干预措施: Caries Removal (Procedure)
Device: Zinc-Reinforced High-Viscosity Glass-ionomer Cement (ChemFil Rock)
The material in capsule form was placed in the mixer (Ultramat 2, SDI, Australia) and mixed for 12 seconds, and applied to the cavity in a single step. In addition to the 90-second working time, an additional 4 and a half minutes were allowed for the material to cure.
干预措施: Filling (Procedure)
结局指标
主要结局
Clinical evaluation of the filling materials according to the modified USPHS criteria
时间窗: Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.
Restorations were evaluated for retention, marginal discoloration, marginal adaptation, color stability, secondary caries, and postoperative sensitivity according to the modified USPHS with scores assigned as follows: the best being Alpha and the worst being Charlie. Each restoration received a score of Alpha, Bravo, or Charlie at each time interval.
次要结局
- Preservation of pulpal vitality(Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.)
研究者
Zulfikar Zahit Ciftci
Head of Pediatric Dentistry
Akdeniz University