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NCT03793413
The Impact of Lingual Frenotomy on Bottle Feeding Mechanics
NA trial testing Lingual frenotomy in Ankyloglossia in 47 participants. Completed in 27 July 2021.
1 August 2020
Quick facts
| Lead sponsor | The Oregon Clinic |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 47 |
| Start date | 1 August 2019 |
| Primary completion | 1 August 2020 |
| Estimated completion | 27 July 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lingual frenotomy
Conditions studied
- Ankyloglossia — all drugs for Ankyloglossia →
- Feeding, Bottle — all drugs for Feeding, Bottle →
- Feeding Disorder of Infancy and Childhood — all drugs for Feeding Disorder of Infancy and Childhood →
Sponsor
The Oregon Clinic
Who can join
Adults 3 Weeks to 12 Weeks, any sex, with Ankyloglossia or Feeding, Bottle. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Conservative estimates show that 3-5% of all infants have tongue tie. These studies only focus on visible, anterior tongue tie. Deeper, more visibly subtle cases of ankyloglossia have not been included in these incidence numbers, so the percentage of children with ankyloglossia is much higher than previously thought. Previous research by the investigators demonstrates that posterior tongue tie can be as problematic as anterior ties. An available FDA-approved feeding solution allows for the measurement of infant sucking motions. This allows for detection of changes following surgical intervention. Previous ultrasound studies show the importance of the upward movement of the tongue, but further lingual movement parameters following frenotomy have not been reported. The primary goal of this study is to record changes in lingual movement following lingual frenotomy. The investigators plan to compare improvements over time between a control, non-intervention group and a frenotomy group. Secondary goals include recording validated outcomes of reflux and feeding efficiency.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03793413
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Related trials
Other recruiting trials for Ankyloglossia
Currently open trials in the same condition.
- NCT07512765 — Ankyloglossia and Its Effects on Breastfeeding, Feeding and Speech Disorders. A Prospective Study From Birth to 4 Years · active not recruiting
Other The Oregon Clinic trials
Trials by the same sponsor.
- NCT06089629 — Frenuloplasty for Speech and Myofunctional Outcomes · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03793413 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Oregon Clinic
- Last refreshed: 14 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03793413.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing