AnkyloglossiaNCT06089629
Frenuloplasty for Speech and Myofunctional Outcomes
A study testing Lingual frenuloplasty in people with Ankyloglossia and Speech Delay, run by The Oregon Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankyloglossia, Speech Delay, Dentofacial Abnormalities
- What is being tested?
- Lingual frenuloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Frenuloplasty for Speech and Myofunctional Outcomes: a Randomized, Controlled Study
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.
Read the 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
- Being tested
- Lingual frenuloplasty
- Keywords
- ankyloglossia, speech delay, myofunctional therapy, dentofacial abnormalities
- Medical subject headings
- Ankyloglossia, Language Development Disorders, Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual frenuloplastyProcedure or surgery
Surgical release of ankyloglossia with suture reorientation of the wound to improve lingual mobility, done under local or general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Nonsurgical intervention with speech and myofunctional therapy |
| Intervention group | Experimental | Surgical intervention with frenuloplasty followed by speech and myofunctional therapy Receives: Procedure: Lingual frenuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech/Articulation
Using the GFTA-3 test of articulation
Measured: 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
Measured: Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
Tongue strength
Using the IOPI instrument
Measured: Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Jul 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnkyloglossiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Oregon Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bobak Ghaheri, MD, The Oregon Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089629
- Sponsor's protocol ID
- Speech2023
- Status last verified
- Apr 2024
- First submitted
- 8 Oct 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frenuloplasty for Speech and Myofunctional Outcomes: a Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT06089629
- Acronym / sponsor ID
- Speech2023
- Conditions
- Ankyloglossia, Speech Delay, Dentofacial Abnormalities
- Keywords
- ankyloglossia, speech delay, myofunctional therapy, dentofacial abnormalities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Oregon ClinicUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Nonsurgical intervention with speech and myofunctional therapy |
| Intervention group | Experimental | Procedure: Lingual frenuloplastySurgical intervention with frenuloplasty followed by speech and myofunctional therapy |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lingual frenuloplastySurgical release of ankyloglossia with suture reorientation of the wound to improve lingual mobility, done under local or general anesthesia | Procedure or surgery | Intervention group |
Primary outcome
Speech/Articulation
Time frame: 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
Time frame: 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
Time frame: Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)
Using the IOPI instrument
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Lingual frenuloplasty in people with Ankyloglossia and Speech Delay, run by The Oregon Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bobak Ghaheri, MD (5034882600, drghaheri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech/Articulation (time frame: Baseline (timepoint 0) and 2 months post-intervention (surgical group) or 2 months post-therapy alone (control group)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.