Clinical Performance of a Moisture Resistant, M-TEG-P Phosphate Monomer-based Universal Adhesive in Geriatric Patients With Non-carious Cervical Lesions (NCLLs):A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Number of fractured restorations
研究概览
简要总结
this trial is to test the clinical performance of a novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) compared to the conventional universal adhesive (3m ESPE Single Bond Universal Adhesive) in geriatric patients with Non-carious Cervical lesions (NCLLs)
详细描述
To evaluate the clinical performance of a novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) compared to the conventional universal adhesive (3m ESPE Single Bond Universal Adhesive) in geriatric patients with Non-carious Cervical lesions (NCLLs)
P: Population: Geriatric patients with non-carious cervical lesions (NCCLs) I: Intervention: Novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) C: Comparator : 3m ESPE Single Bond Universal Adhesive O: Outcome:Clinical Performance using FDI 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-carious cervical lesions in anterior and posterior teeth.
- •Geriatric patients from age 60 years and above.
- •Patients willing to commit to the whole period of the study.
- •Males & Females included.
排除标准
- •Lack of written informed consent to participate
- •Cervical hypersensitivities
- •Underage patients
- •Allergies to components of the materials used
- •Infectious diseases
- •Mucosal diseases with unclear diagnosis
- •Inadequate oral hygiene
- •High caries activity
- •Non-vital pulp
- •Severe periodontal diseases
- •Severe dysgnathia/traumatic occlusion
- •Undergoing orthodontic treatments
- •Undergoing bleaching procedures
结局指标
主要结局
Number of fractured restorations
时间窗: 12 months
First, visual inspection to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure there is no rocking /fracture /ditching in the restoration following FDI criteria ( first visually for total loss followed by tactile inspection using FDI probe for any fracture /rocking or loss of retention.
Number of restorations with retention loss
时间窗: 12 months
First, visual inspection to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure no rocking /fracture /ditching in the restoration following FDI criteria
次要结局
- Number of restoration with change in colour or texture(12 months)
- Number of restoration caused biological harm(12 months)
研究者
Hend Taha Hanafi Mahmoud
Resident in Conservative dentistry department , Cairo University
Cairo University