A COMPARATIVE CLINICAL EVALUATION OF TWO BIOMIMETIC COMPOSITES ON OCCLUSAL RESTORATIONS;A RANDOMIZED SPLIT MOUTH STUDY.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- This in vivo split-mouth study will be done at baseline,1 month, 3 months,6months,
研究概览
简要总结
This in vivo split-mouth study aims to compare the clinical performance of two types of biomimetic composites—supra nano spherical filler composite and nanohybrid composite—in Class I posterior occlusal restorations. Over a 12-month period, 20 patients will receive restorations in two quadrants, with each quadrant randomly assigned one of the composite materials. Clinical assessments will take place at baseline, 1 month, 3 months, 6 months, and 12 months to evaluate wear anatomy, color stability, marginal discoloration, and post-operative sensitivity.
Each material’s performance will be assessed using modified USPHS criteria, while post-operative sensitivity will be evaluated via the Visual Analog Scale (VAS) and USPHS criteria at multiple time points. A total of 40 samples (20 per composite type) will be analyzed. Statistical comparisons will include t-tests, Chi-Square tests, Repeated Measures ANOVA, and Cochran’s Q test, with significance set at p < 0.05. The study’s findings aim to inform practitioners on the longevity and clinical efficacy of single-shade biomimetic composites in posterior restorations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with carious lesions in the age group 18-45 years.
- •2.Patients with carious lesions on the occlusal surface in posterior teeth with remaining dentine thickness [RDT] of 1mm.
- •3.Absence of pain from tooth to be restored.
- •4.Good oral hygiene.
- •Restorations are required in two different quadrants, or at least two teeth.
- •Teeth in contact with adjacent and opposing teeth.
- •7.Patients who are willing to participate in the study.
排除标准
- •1.Patients with pulp and periapical pathologies.
- •Patients with bruxism, attrition, and malocclusion or rotated teeth.
- •Morphological defects.
- •Teeth to be restored in contact with any cuspals coverage or crowns.
结局指标
主要结局
This in vivo split-mouth study will be done at baseline,1 month, 3 months,6months,
时间窗: baseline 1 month | 3 months | 6 months | 12 months
and 12 months intervals.
时间窗: baseline 1 month | 3 months | 6 months | 12 months
The Objectives of this study will be to evaluate and compare;
时间窗: baseline 1 month | 3 months | 6 months | 12 months
ï‚· The clinical performance of wear anatomy, color stability, and marginal
时间窗: baseline 1 month | 3 months | 6 months | 12 months
discoloration of supra nano spherical filler composite in class I posterior
时间窗: baseline 1 month | 3 months | 6 months | 12 months
carious teeth using modified USPHS criteria.
时间窗: baseline 1 month | 3 months | 6 months | 12 months
discoloration of nanohybrid composite in class I posterior carious teeth using
时间窗: baseline 1 month | 3 months | 6 months | 12 months
modified USPHS criteria.
时间窗: baseline 1 month | 3 months | 6 months | 12 months
次要结局
- The post-operative sensitivity in supra nano spherical filler composite and(nanohybrid composite using VAS scale at 1 week and USPHS criteria at)
研究者
Samiha Fathima
the oxford dental college and hospital