Impact of Dentin Pretreatment With Dimethyl Sulfoxide on Behavior of Resin Composite Restorations in Non-Carious Cervical Lesions: 2-year Clinical and Laboratory Investigations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. FDI criteria score-aesthetic properties (A1 surface luster and surface texture; A2 Marginal staining; A3 color match), Functional (F1 Fracture/Retention; F2 marginal adaptation), biological (B1 caries at restoration margin)
研究概览
简要总结
the aim of this study to evaluate and compare the impact of dimethyl sulfoxide dentin surface pretreatment on the performance of composite restorations in non-cervical carious lesions
详细描述
this clinical trial aimed to evaluate the effect of dimethyl sulfoxide (DMSO) pretreatment on the clinical performance of adhesive restorative procedures performed on dentin under wet-bonding conditions. the study will investigate wither DMSO pretreatment can improve the marginal adaptation and clinical performance of resin composite restorations placed in non-carious cervical lesions (NCCL) participants presenting with eligible non-carious lesions will receive adhesive restorative treatment according to the assigned experimental protocol. different adhesive approaches, including with and without DMSO pretreatment, will be compared. clinical outcomes will be evaluated at predefined follow-up periods using standardized clinical assessment criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •following eligibility criteria:
- •Presence of at least two permanent teeth with non-carious cervical lesions (NCCLs) requiring restoration. Lesions were confirmed as non-carious Class V cervical defects using the Smith and Knight Tooth Wear Index (scores 2-3) to ensure standardized dentin exposure without pulpal involvement.(3)
- •The selected teeth were required to be free from mobility and exhibit normal pulpal and periapical status, confirmed by the absence of spontaneous pain, tenderness to percussion, clinical signs of pulpal necrosis, and periapical radiolucency on periapical radiographs.
- •Participants were required to have at least 20 natural teeth in occlusion, with the selected teeth in functional occlusion, to ensure adequate occlusal stability, uniform distribution of masticatory forces, and standardized functional loading.
- •The cavity configuration had to present an incisal margin located in enamel and a gingival margin located in dentin. To standardize the dentin-to-enamel bonding substrate, only lesions with ≤50% of the cavosurface margin in enamel were included.
- •The cervical cavity margin had to be equigingival or supragingival.
- •Dentin sclerosis was assessed before enrollment by visual inspection and tactile examination using a dental explorer according to the University of North Carolina (UNC) Clinical Dentin Sclerosis Scale (scores 1-4). To standardize the dentin substrate and minimize substrate-related variability, only lesions with sclerosis scores of 1 or 2 were included
- •Caries risk was assessed using the Caries Management by Risk Assessment (CAMBRA) protocol. Participants classified as having moderate caries risk were eligible for inclusion. A limited number of high-risk participants were also accepted provided that the only high-risk criterion present was "three or more carious lesions or restorations within the previous 36 months."
- •Participants had to be willing and able to comply with the study protocol and attend all scheduled follow-up visits.
排除标准
- •Participants were excluded if they presented with poor oral hygiene, chronic periodontitis, were undergoing active orthodontic treatment or periodontal surgery, or had xerostomia or were pregnant. Individuals with systemic conditions that could influence oral or periodontal health (e.g., hypertension, diabetes mellitus, malignancy, or other chronic diseases), or those receiving medications known to affect periodontal tissues or wound healing, were also excluded. In addition, participants exhibiting signs of severe parafunctional habits, including clenching or pronounced occlusal wear facets suggestive of bruxism, were not considered eligible for inclusion.
研究组 & 干预措施
etch and rinse adhesive ( 3 steps ) with 5% DMSO dentin surface pretreatment
participants in this group will receive resin composite restorations using etch-and-rinse adhesive system under conventional wet-bonding conditions following pretreatment of dentin substrate with a 5% DMSO solution. after acid aching, the dentin will be maintained in a visibility moist condition and treated with 5% DMSO according to study protocol. the assigned adhesive system and resin composite material will be applied and polymerized in accordance with the standardized clinical protocol.
干预措施: Dimethyl sulfoxide (DMSO) (Other)
etch and rinse adhesive ( 3 steps ) without 5% DMSO dentin surface pretreatment
participants in this group will receive resin composite restorations using etch-and-rinse adhesive system under conventional wet-bonding without DMSO solution treatment . after acid aching, the dentin will be maintained in a visibility moist condition . the assigned adhesive system and resin composite material will be applied and polymerized in accordance with the standardized clinical protocol.
干预措施: NO dimethyl sulfoxide (Other)
结局指标
主要结局
1. FDI criteria score-aesthetic properties (A1 surface luster and surface texture; A2 Marginal staining; A3 color match), Functional (F1 Fracture/Retention; F2 marginal adaptation), biological (B1 caries at restoration margin)
时间窗: Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months
1. Aesthetic properties Restorations will be evaluated for A1 (surface luster and texture), A2 (marginal staining), and A3 (color match). Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. 2. Unit of Measure: FDI score Functional properties Restorations will be evaluated for F1 (fracture/retention) and F2 (marginal adaptation). Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. 3. Unit of Measure: FDI score Biological properties Restoration assessment of B1 (car
FDI criteria score
时间窗: Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months
1\. FDI criteria score-aesthetic properties (A1 surface luster and surface texture; A2 Marginal staining; A3 color match), Functional (F1 Fracture/Retention; F2 marginal adaptation), biological (B1 caries at restoration margin) 1. Aesthetic properties Restorations will be evaluated for A1 (surface luster and texture), A2 (marginal staining), and A3 (color match). Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. 2. Unit of Measure: FDI score Functional properties Restorations will be evaluated for F1 (fracture/retention) and F2 (marginal adaptation). Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. 3. Biological properties Restoration assessment of B1 (caries at restoration margin)
次要结局
未报告次要终点