Frenuloplasty for Speech and Myofunctional Outcomes: a Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Tongue mobility
研究概览
简要总结
Children with ankyloglossia (tongue tie) can have abnormal tongue function, putting them at a disadvantage when it comes to speech and articulation. Furthermore, abnormal tongue posture within the oral cavity increases the likelihood of myofunctional disorders.
详细描述
The current body of literature surrounding ankyloglossia and speed delay is mixed. The literature base is riddled with retrospective reviews, poor descriptions of surgical intervention, and the lack of standardized grading schemes with respect to articulation. Furthermore, the candidacy for intervention in these instances only involves children with anterior tongue tie. There is a complete lack of investigation surrounding the impact of posterior tongue tie on articulation.
The other area that has inadequately been studied is the impact ankyloglossia has on myofunctional outcomes. There are data now that demonstrate how ankyloglossia is correlated with a vaulted palate and has long term orthodontic consequences. This study aims to demonstrate how release of posterior tongue tie improves lingual strength and posture.
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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ages 5-12 with posterior tongue tie who are undergoing treatment just for ankyloglossia
- •Children must already be working with an SLP who has done a speech and myofunctional evaluation
排除标准
- •Children undergoing other procedures at the same time as the frenuloplasty (tonsillectomy, adenoidectomy, etc)
- •Significant medical comorbidities (cardiovascular, neurological, etc)
- •Anterior tongue tie or lip tie
- •Previous lingual surgery
结局指标
主要结局
Tongue mobility
时间窗: Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
Using the TRMR grading scale
Tongue strength
时间窗: Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
Using the IOPI instrument
Speech/Articulation
时间窗: Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
Using the GFTA-3 test of articulation
次要结局
未报告次要终点
研究者
Bobak Ghaheri, MD
Otolaryngologist
The Oregon Clinic