Frenuloplasty for Speech and Myofunctional Outcomes: a Randomized, Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- The Oregon Clinic
- Enrollment
- 50
- Primary Endpoint
- Tongue mobility
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Control group
Nonsurgical intervention with speech and myofunctional therapy
Intervention group
Surgical intervention with frenuloplasty followed by speech and myofunctional therapy
Intervention: Lingual frenuloplasty (Procedure)
Outcomes
Primary Outcomes
Tongue mobility
Time Frame: 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
Time Frame: Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
Using the IOPI instrument
Speech/Articulation
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Bobak Ghaheri, MD
Otolaryngologist
The Oregon Clinic