Frenuloplasty for Speech and Myofunctional Outcomes

Ankyloglossia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06089629
• Other study ID #: Speech2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: The Oregon Clinic
• Contact: Bobak Ghaheri, MD
• Phone: 5034882600
• Email: drghaheri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankyloglossia
• Congenital Abnormalities
• Dentofacial Abnormalities
• Dentofacial Deformities
• Language Development Disorders
• Speech Delay

Intervention

Procedure:
• Lingual frenuloplasty
Surgical release of ankyloglossia with suture reorientation of the wound to improve lingual mobility, done under local or general anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Oregon Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Tongue strength	Using the IOPI instrument	Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)