An interventional study of Lingual frenuloplasty in Ankyloglossia, Speech Delay and Dentofacial Abnormalities, sponsored by The Oregon Clinic. Not yet recruiting. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by The Oregon Clinic · Not applicable, Interventional, and Treatment
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.
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.
32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.
This study's planned enrollment of 50 is below the median of 105 across 22 interventional studies indexed under Ankyloglossia.
Browse Ankyloglossia studies →The Oregon Clinic is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Nonsurgical intervention with speech and myofunctional therapy
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
Speech/Articulation
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)
Tongue mobility
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)
Tongue strength
Using the IOPI instrument
Time frame: Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2024; primary completion for Apr 2025, 9 months later.
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This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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The Oregon Clinic