Clinical Performance of Nano-filled Resin-modified Glass Ionomer and Sub-micron Hybrid Resin Composite Restorations in Permanent Molar Teeth:18-month Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 主要终点
- Recurrent Decay
研究概览
简要总结
The aim of this randomised controlled double-blinded, split mouth, single-center clinical trial was to evaluate the 18-month clinical performance of nano-filled resin-modified glass ionomer and sub-micron hybrid resin composite restorations in lower first permanent teeth of pediatric patients.
详细描述
Occlusal carious lesions on the left and right mandibular first molar teeth of 96 pediatric patients (54 female, 42 male) were restored in a split-mouth study design. Nano-filled resin-modified glass ionomer (Nano-RMGIC) (Ketac N 100, 3M/ESPE, USA) was used to restore the carious lesions for patients in the treatment group while a sub-micron hybrid resin composite (SpectrumTPH3, Dentsply, USA) was used for patients in the control group. Clinical evaluation of restorations were performed at the 1st week, 6th, 12th and 18th month recalls by two calibrated examiners according to the Modified-USPHS criteria.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with two comparable occlusal carious lesions on both mandibular first permanent molars.
- •Neutral occlusion with a natural antagonist tooth
- •Patients that are able to come to recalls
- •Patients with a good oral hygiene
排除标准
- •Patients suffering systemic diseases or allergies
- •Patients with gastrointestinal problems
- •Mandibular first molar teeth with restorations
- •Patients with oral habits
- •Patients receiving orthodontic treatment
- •Hypomineralized or Hypoplastic first molars
结局指标
主要结局
Recurrent Decay
时间窗: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Recurrent decay of dental restorations were observed by two calibrated examiners with visual inspection. Restorations were scored Alfa or Charlie according to Modified USPHS criteria. (Alfa: No evidence of recurrent caries along the margin of the restoration, Charlie: Evidence of caries along the margin of the restoration.)
Anatomic Form
时间窗: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Anatomic form of dental restorations were observed by two calibrated examiners by visual inspection and explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: The restoration is not under-contoured, Bravo: The restoration is under-contoured, but there is no dentin or base exposed, Charlie: Sufficient restorative material is missing so that dentin or base is exposed.
Marginal Integrity
时间窗: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Marginal integrity of dental restorations were observed by two calibrated examiners with visual inspection and explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: No visible evidence of a crevice along the margin into which an explorer will catch, Bravo: The explorer catches a crevice along the margin but there is no exposure of dentin or base, Charlie: Visible evidence of a crevice with exposure of dentin or base.)
Postoperative Sensitivity
时间窗: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Postoperative sensitivity of patients were assessed by two calibrated examiners by cold thermal test. Restorations were scored Alfa or Charlie according to Modified USPHS criteria. (Alfa: No sensitivity, Charlie: Sensitivity present.)
Color Match
时间窗: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Color match of dental restorations were observed with a Vita Scale visually by two calibrated examiners. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. ( Alfa: Imperceptible in room light in one-second glance, Bravo: Perceptible mismatch with the Vita scale but clinically acceptable, Charlie: Esthetically unacceptable)
Marginal Discoloration
时间窗: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Marginal discoloration of dental restorations were observed by two calibrated examiners with visual inspection. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: No existing marginal discoloration, Bravo:Presence of discoloration at margins between restoration and tooth structure; discoloration does not penetrate towards the pulp, Charlie: The discoloration penetrated along the margins of the restoration in a pulpal direction.
Fracture
时间窗: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Fracture of dental restorations were observed by two calibrated examiners by visual inspection with explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: No fracture, Bravo: Small chip, but clinically acceptable, Charlie: Failure due to bulk restoration fracture.)
Surface Texture
时间窗: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Surface texture of dental restorations were observed by two calibrated examiners by visual inspection and explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: Enamel like surface, Bravo: Surface rougher then enamel, clinically acceptable, Charlie: Surface unacceptable rough.)
次要结局
未报告次要终点
研究者
Nadya Marie Hacinlioglu
Associate Professor, Cyprus Health and Social Sciences University
Hacinlioglu, Nadya Marie