Frenuloplasty for Speech and Myofunctional Outcomes

Sponsor

The Oregon Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06089629

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ankyloglossia Speech Delay Dentofacial Abnormalities	Procedure: Lingual frenuloplasty	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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