Evaluation of Oral Health in Unilateral Cleft Lip and Palate Patients Undergoing Maxillary Expansion: A Periodontal and Microbiological Analysis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To analyze periodontal status and the microbiota of plaque in patients with cleft lip and palate undergoing orthodontic treatment for maxillary expansion with NiTi palatal expander or clear Aligners.
研究概览
简要总结
Cleft lip and palate (CLP), one of the most prevalent craniofacial abnormalities, accounts for about 15% of all congenital deformities worldwide. Patients with CLP have a higher risk of periodontal disease due to poorly developed hard tissue structures, altered soft tissues, and developmental disturbances affecting tooth structure, form, and number, particularly in the upper incisors near the cleft region. While a few studies have compared periodontal health and subgingival plaque microbes in cleft and non-cleft areas, no research has examined these factors in CLP patients undergoing orthodontic maxillary expansion with different appliances. This study aims to evaluate the periodontal status and plaque microbiota in CLP patients treated with NiTi palatal expanders or clear Aligners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 7.00 Year(s) 至 11.00 Year(s)（—）
- 性别
- All
入选标准
- •Complete unilateral cleft lip and palate Age 7 to 11 years Both sexes.
排除标准
- •Syndromic cleft lip and palate patients Individuals with systemic diseases affecting bone density Bilateral cleft lip and palate patients.
结局指标
主要结局
To analyze periodontal status and the microbiota of plaque in patients with cleft lip and palate undergoing orthodontic treatment for maxillary expansion with NiTi palatal expander or clear Aligners.
时间窗: T0- Baseline | T1- After completion of expansion
次要结局
未报告次要终点
研究者
Dr Riddhi Bansal
Manav Rachna Dental College