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Frenuloplasty for Speech and Myofunctional Outcomes

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06089629
Enrollment
50
Registered
2023-10-18
Start date
2024-07-01
Completion date
2025-12-01
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankyloglossia, Dentofacial Abnormalities, Speech Delay

Keywords

ankyloglossia, speech delay, myofunctional therapy, dentofacial abnormalities

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.

Interventions

PROCEDURELingual frenuloplasty

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

Sponsors

The Oregon Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Speech/ArticulationBaseline (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 mobilityBaseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)Using the TRMR grading scale
Tongue strengthBaseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)Using the IOPI instrument

Contacts

Primary ContactBobak Ghaheri, MD
drghaheri@gmail.com5034882600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026