Frenuloplasty for Speech and Myofunctional Outcomes

Not Applicable

Not yet recruiting

• Conditions: Ankyloglossia; Speech Delay; Dentofacial Abnormalities
• Interventions: Procedure: Lingual frenuloplasty

• Registration Number: NCT06089629
• Lead Sponsor: The Oregon Clinic

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 Timeline

• Study First Submitted: 2023-10-08
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03
• Study Start: 2024-07-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Lingual frenuloplasty	Surgical intervention with frenuloplasty followed by speech and myofunctional therapy

Primary Outcome Measures

Name	Time	Method
Tongue mobility	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	Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)	Using the IOPI instrument
Speech/Articulation	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