Frenuloplasty for Speech and Myofunctional Outcomes

NCT06089629 | Not Yet Recruiting

• 1 other identifier: Speech2023
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ankyloglossia; Speech Delay; Dentofacial Abnormalities

Keywords

ankyloglossia; speech delay; myofunctional therapy; dentofacial abnormalities

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

Control group

NO INTERVENTION

Nonsurgical intervention with speech and myofunctional therapy

Intervention group

EXPERIMENTAL

Surgical intervention with frenuloplasty followed by speech and myofunctional therapy

Procedure: Lingual frenuloplasty

Interventions

Lingual frenuloplasty PROCEDURE

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

Intervention group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Oregon Clinic: lead

MeSH Terms

Conditions

Ankyloglossia; Language Development Disorders; Dentofacial Deformities

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Bobak Ghaheri, MD

CONTACT

5034882600; drghaheri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Otolaryngologist

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 18, 2023
• Study Start: July 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share