Separation Effect, Plaque Score, Pain Perception, And Impact On Quality Of Life When Comparing Three Types Of Orthodontic Separators: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Amount of Tooth Separation Achieved
研究概览
简要总结
Orthodontic separators are small devices placed between teeth before fitting braces to create space for bands. This procedure may cause pain, discomfort, and changes in oral hygiene, which can affect plaque buildup and daily activities.
This study aims to compare three commonly used types of orthodontic separators-elastomeric, Kesling, and customized tie wire separators-in terms of the amount of tooth separation achieved, pain experienced by patients, and plaque accumulation.
In addition, the study will assess how these separators affect patients' quality of life, including eating, speaking, and daily comfort.
Participants will be assigned to one of the three separator types and will be evaluated after 48 to 72 hours. The findings of this study may help identify the most effective and comfortable separator, improving patient care and treatment experience in orthodontics.
详细描述
Separation of teeth prior to molar banding is an essential step in fixed orthodontic treatment. Orthodontic separators are used to create sufficient interproximal space to allow proper placement of bands. However, separator placement is commonly associated with pain, discomfort, and changes in oral hygiene practices, which may lead to plaque accumulation and negatively impact patients' quality of life.
Various types of orthodontic separators are available, including elastomeric separators, spring-type separators such as Kesling separators, and customized separators such as ligature tie wire separators. Elastomeric separators are widely used due to ease of placement; however, they may cause significant pain and are prone to dislodgement. Kesling separators are effective in tight contact areas but may cause gingival irritation and are relatively difficult to handle. Tie wire separators, which can be fabricated chairside, may offer a cost-effective and practical alternative, especially in cases with tight interproximal contacts.
This randomized controlled trial aims to compare three types of orthodontic separators-elastomeric, Kesling, and customized tie wire separators-in terms of:
Amount of separation achieved Pain perception using a visual analogue scale (VAS) Plaque accumulation measured using the Silness and Loe plaque index Impact on patients' quality of life assessed through structured interviews
A total of 144 participants requiring fixed orthodontic treatment with molar banding will be randomly allocated into three groups. Separators will be placed on the mesial and distal surfaces of maxillary first molars. Clinical parameters will be assessed after 48-72 hours.
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)
盲法说明
The outcome assessor responsible for measuring separation and recording pain scores will be blinded to group allocation. Participants and care providers will not be blinded due to the nature of the interventions.
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients requiring fixed orthodontic appliance therapy with maxillary first molar banding
- •Age between 12 and 25 years
- •Good oral hygiene (Plaque Index score 0-1)
- •Good general oral health
- •No previous orthodontic treatment
- •No history of dental extractions
- •Presence of tight interproximal contacts at the site of separator placement (no spacing)
排除标准
- •Presence of interproximal restorations
- •Presence of interproximal caries
- •Missing maxillary second premolar, first molar, or second molar
- •Unerupted maxillary second molars
- •Systemic diseases affecting oral health (e.g., diabetes mellitus)
- •Regular use of medications affecting pain perception (e.g., analgesics, corticosteroids)
- •Loss of separators before follow-up appointment
- •Failure to return within 72 hours for evaluation
研究组 & 干预措施
Elastomeric Separator Group
Participants will receive elastomeric separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding.
干预措施: Elastomeric Separator (Device)
Kesling Separator Group
participants will receive Kesling (spring-type) separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding.
干预措施: Kesling Separator (Device)
Tie Wire Separator Group
Participants will receive customized ligature tie wire separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding.
干预措施: Tie wire separator (Device)
Elastomeric Separator Group
Participants will receive elastomeric separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding.
干预措施: Tie wire separator (Device)
Kesling Separator Group
participants will receive Kesling (spring-type) separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding.
干预措施: Elastomeric Separator (Device)
Tie Wire Separator Group
Participants will receive customized ligature tie wire separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding.
干预措施: Kesling Separator (Device)
结局指标
主要结局
Amount of Tooth Separation Achieved
时间窗: 48 to 72 hours after separator placement
Interproximal separation between maxillary first molars measured using a leaf gauge (COMBO TECH incremental thickness gauge) on mesial and distal surfaces. Mean separation will be calculated.
次要结局
未报告次要终点