Clinical Evaluation of Gingival and Periodontal Health of Lower Anterior Teeth With Fixed Retainer Versus Removable Retainer: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Probing depth
研究概览
简要总结
One of the most crucial aspects of orthodontic therapy is retention, which is required to prevent orthodontic relapse . There are two main types of retainers, removable retainer which depends on patient compliance to achieve proper results, and fixed retainer which can overcome the problem of patient compliance, but with using it there is higher risk of plaque accumulation and the process of brushing teeth becomes more complex. However, it is not known whether this necessarily leads to worsening of periodontal outcomes . The increasing use of permanent retainers and their requirement for continuous wear highlight the importance of evaluating their impact on the periodontal health but there is conflicting data available right now on how orthodontic retainers affect periodontal diseases
详细描述
The purpose of this research is to compare the effect between fixed and removable retainer on periodontium as the current evidence on how these appliances affect periodontal health is still lacking significantly Orthodontic treatment plays an important role in enhancing the function, esthetics and overall well-being of patients. One of the most important elements of treatment is the retention phase. There are two main types of retainers that can be used in the retention phase either fixed or removable.
At first banded fixed appliances were used as retainers , then in 1919 Hawly introduced removable retainers , then in 1973 Kneirim RW. introduced the first bonded retainer as enamel etching and modern adhesive systems facilitated the use of bonded retention .
The most widely used removable retainer is the Hawley appliance, which is made of wire and acrylic resin.
In 1971 Ponitz introduced fiber reinforced retainer which is less expensive, with better esthetics and easy to clean but it is not dimensionally stable and more prone to wearing.
The duration of the retention phase frequently exceeds that of the active treatment. In many cases, orthodontists even propose lifetime retention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimal age of twelve years.
- •Presence of all mandibular anterior teeth from canine to canine.
- •Completion of orthodontic multi-bracket treatment with the requirement of retention of the mandibular anterior teeth.
- •Periodontal screening index ≤ 2 [18].
- •Participation in all study visits.
排除标准
- •Systemic disease potentially affecting the study outcome.
- •Conditions requiring antibiotic prophylaxis for clinical measurements that trigger transitory bacteremia.
- •Pregnant females.
- •Chronic use of medications affecting the study outcome.
- •Patients with active periodontal disease
研究组 & 干预措施
intervention group ( fixed retainer group)
- At first, medical and dental histories will be taken from the patients then extra- and intra-oral examinations will follow.
- Brackets are removed using a plier at the end of active orthodontic treatment.
- Excess adhesive material is removed using finishing stones and rubber polishing kit.
- Polishing the teeth before placement of retainer. For the fixed retainer group, it will be fabricated from a stainless-steel alloy and applied to each lingual tooth surface from one mandibular canine to the contralateral canine.
The patients' teeth surfaces will then be prepared using 37% phosphoric acid etchant gel for 30 seconds, rinsed and dried with oil-free compressed air for 10 seconds. After drying the enamel surfaces, a bonding agent will be applied using a micro-brush, spread using oil-free compressed air followed by the application of the adhesive material and placement of the fixed retainer. After light curing excess adhesive material will be removed.
干预措施: Fixed retainer (Device)
control group ( vacuum retainer group)
At first, medical and dental histories will be taken from the patients then extra- and intra-oral examinations will follow.
- Brackets are removed using a plier at the end of active orthodontic treatment.
- Excess adhesive material is removed using finishing stones and rubber polishing kit.
- Polishing the teeth before placement of retainer.
For the removable retainer group the mandibular removable retainers will be fabricated using thick thermoplastic vacuum-formed sheets, patients will be instructed to wear them full- time.
干预措施: vacuum retainer (Device)
结局指标
主要结局
Probing depth
时间窗: immediately after debonding and after 6 months
Assessment of periodontal health using Periodontal probing depth Probing depth is measured in mms using periodontal probe, in a healthy periodontium pocket typically measures between 1 to 3 millimeters in depth
Bleeding on probing
时间窗: immediately after debonding and after 6 months
Bleeding on probing is a 4 point scale Score 0: No bleeding No bleeding when you probe the gingival sulcus/pocket Score 1: Bleeding on probing Bleeding occurs after probing, usually within 10-30 seconds ,Mild bleeding at the gingival margin Score 2: Bleeding + profuse Bleeding is immediate, profuse, and often fills the sulcus, Or bleeding flows from the sulcus Score 3: Spontaneous bleeding, Bleeding occurs without any probing Seen before you even touch the tissue
gingival recession
时间窗: immediately after debonding and after 6 months
Loss of clinical attachment level is measured as the distance in millimeters between the bottom of the pocket and the cementoenamel junction. Based on the extent of attachment loss, it can be categorized as light (1-2 mm), moderate (3-4 mm), or severe (5 mm or more) loss of clinical attachment.
Gingival index
时间窗: immediately after debonding and after 6 months
Gingival index is a 4-point scale in which scale 0 is healthy periodontium and scale 3 is severe inflammation.
plaque index
时间窗: immediately after debonding and after 6 months
Plaque index is a 4-point scale in which scale 0 indicates the absence of plaque at the free gingival margin after drying, and scale 3 represents an abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface, including the interdental area
次要结局
- patient satisfaction(After 6 months)
研究者
Toka Mustafa Saad Mohamed
principal investigator
Cairo University