Frenuloplasty for Speech and Myofunctional Outcomes

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.

Official Title
-----------------
Frenuloplasty for Speech and Myofunctional Outcomes: a Randomized, Controlled Study

Conditions
-----------------
Ankyloglossia, Speech Delay, Dentofacial Abnormalities

Intervention / Treatment
-----------------
* Procedure: Lingual frenuloplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Nonsurgical intervention with speech and myofunctional therapy | |
| Experimental: Intervention group<br>Surgical intervention with frenuloplasty followed by speech and myofunctional therapy | Procedure: Lingual frenuloplasty<br>* Surgical release of ankyloglossia with suture reorientation of the wound to improve lingual mobility, done under local or general anesthesia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech/Articulation | Using the GFTA-3 test of articulation | Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group) | 
| Tongue mobility | Using the TRMR grading scale | Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group) | 
| Tongue strength | Using the IOPI instrument | Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ankyloglossia, speech delay, myofunctional therapy, dentofacial abnormalities