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CompletedNCT02936518Updated Sep 20, 2017

Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study

An interventional study of Lingual frenotomy and/or maxillary labial frenectomy in Ankyloglossia and Breastfeeding, sponsored by The Oregon Clinic. Completed. Open to participants aged 1 Day to 8 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-20.

Sponsored by The Oregon Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
1 Day to 8 Months
Sex
All
01

Study summary

A previously published study (https://www.ncbi.nlm.nih.gov/pubmed/27641715) identified breastfeeding improvements following lingual frenotomy and/or maxillary labial frenectomy. In the previous cohort, babies were excluded from the study if they had previously undergone an attempted frenotomy prior to seeing the P.I. in the office. The proposed study will only look at those babies who did undergo a previous frenotomy to determine:

  1. the presence of continued problematic breastfeeding symptoms
  2. if further tongue tie or lip tie release improves those outcomes
02

Conditions studied

  • Ankyloglossia
  • Breastfeeding

Keywords

  • ankyloglossia
  • breastfeeding
  • lip tie
03

In context

Ankyloglossia

32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.

This study's planned enrollment of 55 is below the median of 105 across 22 interventional studies indexed under Ankyloglossia.

Browse Ankyloglossia studies →

Lead sponsor

The Oregon Clinic is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 8 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy babies who are breastfeeding
  • Had a previous frenotomy prior to presenting to the P.I.

Exclusion criteria

Exclusion Criteria:

  • Twins, triplets
  • Maternal breast surgery or IGT
  • Premature birth
  • Significant heart/lung/brain disease of infant
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    Intervention

    Procedure: Lingual frenotomy and/or maxillary labial frenectomy

Interventions

  • ProcedureLingual frenotomy and/or maxillary labial frenectomy
06

What researchers measure

Primary outcomes

  1. Nipple pain

    Time frame: 1 week post-procedure

  2. Reflux (i-GERQ-R)

    Time frame: 1 week and 1 month post-procedure

  3. Maternal breastfeeding self-efficacy (BSES-SF)

    Time frame: 1 week and 1 month post-procedure

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • O'Callahan C, Macary S, Clemente S. The effects of office-based frenotomy for anterior and posterior ankyloglossia on breastfeeding. Int J Pediatr Otorhinolaryngol. 2013 May;77(5):827-32. doi: 10.1016/j.ijporl.2013.02.022. Epub 2013 Mar 22. PubMed 23523198 ↗
  • Geddes DT, Langton DB, Gollow I, Jacobs LA, Hartmann PE, Simmer K. Frenulotomy for breastfeeding infants with ankyloglossia: effect on milk removal and sucking mechanism as imaged by ultrasound. Pediatrics. 2008 Jul;122(1):e188-94. doi: 10.1542/peds.2007-2553. Epub 2008 Jun 23. PubMed 18573859 ↗
  • Ghaheri BA, Cole M, Fausel SC, Chuop M, Mace JC. Breastfeeding improvement following tongue-tie and lip-tie release: A prospective cohort study. Laryngoscope. 2017 May;127(5):1217-1223. doi: 10.1002/lary.26306. Epub 2016 Sep 19. PubMed 27641715 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2014, a primary completion of Apr 2015 and a completion of Jun 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2016
First posted
Oct 18, 2016
Start
Jun 2014
Primary completionActual
Apr 2015
CompletionActual
Jun 2017
Last update
Sep 20, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02936518
Lead sponsor
The Oregon Clinic
Responsible party
Bobak Ghaheri, MD (Otolaryngologist/Head and Neck Surgeon, The Oregon Clinic) — Principal investigator
First posted
Oct 18, 2016
Start date
Jun 2014
Primary completion
Apr 2015
Completion
Jun 2017
Last update
Sep 20, 2017
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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