Frenuloplasty for Speech and Myofunctional Outcomes

NCT ID: NCT06089629

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-12-01

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.

Conditions

Ankyloglossia; Speech Delay; Dentofacial Abnormalities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Nonsurgical intervention with speech and myofunctional therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

Surgical intervention with frenuloplasty followed by speech and myofunctional therapy

Group Type: EXPERIMENTAL

Lingual frenuloplasty

Intervention Type: PROCEDURE

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

Interventions

Lingual frenuloplasty

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Oregon Clinic

OTHER

Sponsor Role: lead

Responsible Party

Bobak Ghaheri, MD

Otolaryngologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Bobak Ghaheri, MD

Role: CONTACT

drghaheri@gmail.com

5034882600

Other Identifiers

Speech2023

Identifier Type: -

Identifier Source: org_study_id