Back to resultsFrenuloplasty for Speech and Myofunctional Outcomes
Primary Purpose
Ankyloglossia, Speech Delay, Dentofacial Abnormalities
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lingual frenuloplasty
Sponsored by
About this trial
This is an interventional treatment trial for Ankyloglossia focused on measuring ankyloglossia, speech delay, myofunctional therapy, dentofacial abnormalities
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Intervention group
Arm Description
Nonsurgical intervention with speech and myofunctional therapy
Surgical intervention with frenuloplasty followed by speech and myofunctional therapy
Outcomes
Primary Outcome Measures
Speech/Articulation
Using the GFTA-3 test of articulation
Tongue mobility
Using the TRMR grading scale
Tongue strength
Using the IOPI instrument
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06089629
Brief Title
Frenuloplasty for Speech and Myofunctional Outcomes
Official Title
Frenuloplasty for Speech and Myofunctional Outcomes: a Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Oregon Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankyloglossia, Speech Delay, Dentofacial Abnormalities
Keywords
ankyloglossia, speech delay, myofunctional therapy, dentofacial abnormalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Nonsurgical intervention with speech and myofunctional therapy
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Surgical intervention with frenuloplasty followed by speech and myofunctional therapy
Intervention Type
Procedure
Intervention Name(s)
Lingual frenuloplasty
Intervention Description
Surgical release of ankyloglossia with suture reorientation of the wound to improve lingual mobility, done under local or general anesthesia
Primary Outcome Measure Information:
Title
Speech/Articulation
Description
Using the GFTA-3 test of articulation
Time Frame
Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
Title
Tongue mobility
Description
Using the TRMR grading scale
Time Frame
Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
Title
Tongue strength
Description
Using the IOPI instrument
Time Frame
Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bobak Ghaheri, MD
Phone
5034882600
Email
drghaheri@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Frenuloplasty for Speech and Myofunctional Outcomes
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