Effect of Direct Anterior Diastema Closure Treatment on Oral Health-related Quality of Life and Dental Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Oral Health-Related Quality of Life (OHIP-14 Score)
研究概览
简要总结
The aim of this study is to evaluate the effects of non-invasive direct anterior diastema closure on dental anxiety and oral health-related quality of life in adults with maxillary anterior diastema. Direct composite resin restorations are widely used for diastema closure due to their minimally invasive nature, cost-effectiveness, and ability to be completed in a single clinical visit. However, limited information is available regarding the psychological and quality-of-life outcomes of this treatment.
In this prospective single-arm clinical study, adult participants presenting with anterior diastema receive non-invasive direct composite restorations for diastema closure. Dental anxiety and oral health-related quality of life are assessed using the Modified Dental Anxiety Scale (MDAS) and the Oral Health Impact Profile-14 (OHIP-14). Participants complete these questionnaires before treatment and three months after the restorative procedure. The study aims to determine whether direct anterior diastema closure improves oral health-related quality of life and reduces dental anxiety in affected individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Absence of previous restorative treatment (including restorative, endodontic, or prosthetic procedures)
- •Periodontally healthy teeth
- •Presence of anterior diastema with a width of less than 2 mm
- •Absence of malocclusion
- •Good general systemic health
- •No use of anxiety-reducing pharmacological agents (e.g., sedatives, anxiolytics, or analgesics) prior to treatment
排除标准
- •Presence of cognitive or psychiatric disorders
- •History of substance abuse
- •Presence of malignant diseases
- •Presence of acute dental or periodontal conditions
研究组 & 干预措施
Direct Anterior Diastema Closure
Participants with maxillary anterior diastema received non-invasive direct anterior diastema closure using direct composite resin restorations.
干预措施: Direct Composite Resin Restoration for Anterior Diastema Closure (Procedure)
结局指标
主要结局
Change in Oral Health-Related Quality of Life (OHIP-14 Score)
时间窗: Baseline and 3 months after treatment
Oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14). The total score ranges from 0 to 56, with higher scores indicating poorer oral health-related quality of life.
Change in Dental Anxiety (MDAS Score)
时间窗: Baseline and 3 months after treatment
Dental anxiety assessed using the Modified Dental Anxiety Scale (MDAS). Total scores range from 5 to 25, with higher scores indicating greater dental anxiety.
次要结局
未报告次要终点
研究者
fatih bedir
assistant professor
Recep Tayyip Erdogan University