Frenuloplasty for Speech and Myofunctional Outcomes

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Speech Delay; Ankyloglossia; Dentofacial Abnormalities
• Intervention / Treatment: Procedure: Lingual frenuloplasty

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bobak Ghaheri, MD; Phone Number: 5034882600; Email: drghaheri@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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)

Collaborators and Investigators

• Sponsor: The Oregon Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 8, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: myofunctional therapy; speech delay; ankyloglossia; dentofacial abnormalities
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Musculoskeletal Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Language Disorders; Communication Disorders; Congenital Abnormalities; Language Development Disorders; Dentofacial Deformities; Ankyloglossia
• Other Study ID Numbers: Speech2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No