Periodontal and Orthodontic Outcomes of Straight Versus Looped Fixed Retainers: a Split-mouth Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Measurement of the Little's Irregularity Index to assess the crowding of Mandibular anterior arch
研究概览
简要总结
The goal of this split-mouth, head-to-head, randomized controlled trial is to compare the effects of a fixed straight retainer with the V- loop bonded retainer on periodontal health in patients with the requirement of continuous fixed retention for 12-24 months after orthodontic treatment.
The main question it aims to answer is whether the V- loop bonded retainer is more effective than fixed straight retainer for periodontal health management.
Each patient will receive 2 lower fixed and bonded retainers: (1) a straight wire retainer (SWR) and (2) a looped wire retainer (LWR). Patients will be asked to floss once daily with a thread flosser.
Researchers will compare the effects of two types of retainers to see if there is a statistically significant difference.
详细描述
Ensuring alignment stability is a major challenge for orthodontists following an orthodontic treatment. This has led to the development of various orthodontic retention methods to enhance stability. Both fixed and removable retainers have been in use for years. However, most orthodontists nowadays prefer fixed bonded retainers over removable ones due to their many advantages, including easy to wear, being patient compliance free, long-term usability and stability, and better aesthetics. Over the past decades, many variations of fixed retainers have been developed. Of these, the current gold standard is the straight type flexible spiral (multistranded) wire retainer. Nevertheless, a major concern of using fixed straight retainers is the potential for periodontal health compromise. They are known to make oral hygiene maintenance more difficult for the patient, which in turn may lead to periodontal diseases due to more plaque and calculus accumulation. The wave or V- loop bonded retainer may be a solution to this problem, as it provides stability of teeth yet allows flossing with ease.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in need of continuous fixed retention for 12-24 months after orthodontic treatment
- •Good periodontal health (i.e., no clinical attachment loss and < 10% bleeding on probing)
排除标准
- •History of oral prophylaxis in the past 6 months
- •History of any systemic illness such as diabetes
- •Preexisting or post-orthodontic periodontal disease
- •Current intake of antibiotic and/or anti-inflammatory medications
- •Pregnancy
结局指标
主要结局
Measurement of the Little's Irregularity Index to assess the crowding of Mandibular anterior arch
时间窗: Approximately 2 years
The examination will be carried out for each participant to assess the final outcome assigned interventions immediately following the orthodontic treatment and after intervals of six months and two years. The scale of the index includes the following: * 0: Perfect Alignment * 1-3: Minimal Irregularity * 4-6: Moderate Irregularity * 7-9: Severe Irregularity * 10: Very Severe Irregularity The value represents the total horizontal displacement of the anatomical contact points of the mandibular anterior teeth in millimeters.
Evaluation of retainer failures and teeth stability through clinical examination
时间窗: Approximately 2 years
The examination will be carried out for each participant to assess the final outcome of bonds of assigned intervention immediately following the orthodontic treatment and after intervals of six months and two years.
次要结局
- Change from Baseline (immediately following the orthodontic treatment) in gingivitis on the 4-point Modified Gingival Index (MGI) at the short-term (6 months) and long-term (2 years)(Approximately 2 years)
- Change from Baseline (immediately following the orthodontic treatment) in plaque accumulation on O'leary Plaque Index (PI) at the short-term (6 months) and long-term (2 years)(Approximately 2 years)
- Change from Baseline (immediately following the orthodontic treatment) in oral hygiene questionnaire at the short-term (6 months) and long-term (2 years)(Approximately 2 years)
- Change from Baseline (immediately following the orthodontic treatment) in gingival bleeding on the Gingival Bleeding Index (GBI) by Ainamo and Bay at the short-term (6 months) and long-term (2 years)(Approximately 2 years)
研究者
Talal Zahid
Associate Professor | Chairman, Department of Periodontics
King Abdulaziz University