AnkyloglossiaNCT02642133
Breastfeeding Improvement Following Tongue-tie and Lip-tie Release
A study testing Lingual Frenotomy and/or maxillary labial frenectomy in people with Ankyloglossia and Breastfeeding, run by The Oregon Clinic.
Trial summary
This study is an observational study to determine outcomes of surgical release of tongue-tie and lip-tie in babies who are experiencing difficulty with breastfeeding. Read more about this study
- Who is it for?
- Ages 1 day to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Ankyloglossia, Breastfeeding
- What is being tested?
- Lingual Frenotomy and/or maxillary labial frenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2015
- 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 1 day to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy babies who are breastfeeding 0-12 weeks of age
Who cannot join
- Serious comorbid conditions (heart, lung, brain)
- Prior maternal breast surgery
- Insufficient glandular tissue
- Previous tongue/lip surgery
- Twins/Triplets
About this study
Official title: Breastfeeding Improvement Following Tongue-tie and Lip-tie Release: A Prospective Cohort Study
This study is an observational study to determine outcomes of surgical release of tongue-tie and lip-tie in babies who are experiencing difficulty with breastfeeding.
Read the detailed description
Breastfeeding rates in the United States initiate at around 80%, but many mothers are unable to effectively breastfeeding because of problems with latch and suction generation. Previous studies have demonstrated how nipple pain is directly linked to ankyloglossia, but most of these studies are done with poor methodology.
Clinically, tongue-tie and lip-tie have correlate with numerous other symptoms besides nipple pain. These babies tend to be inefficient nursers, which can affect weight gain. Abnormal intake of air because of the poor latch/seal can lead to reflux symptoms. Finally, there is a significant psychological toll on mothers who want to breastfeed but cannot do so.
This study aims to prospectively analyze these outcomes by using validated tools.
- Conditions
- Ankyloglossia, Breastfeeding
- Being tested
- Lingual Frenotomy and/or maxillary labial frenectomy
- Medical subject headings
- Ankyloglossia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual Frenotomy and/or maxillary labial frenectomyProcedure or surgery
The procedure is performed with a 1064nm InGaAsP semiconductor diode laser which is a soft tissue laser with variable pulsed wave and wattage settings. The procedure was performed at 0.7-0.8 pulsed watts, 200 microseconds on and 100 microseconds off (actual wattage: 0.47 to 0.53 W) using a 300 micron laser fiber. The tongue is elevated using a grooved director while the laser tip is applied to the frenulum. If present, the anterior frenulum is divided until the submucosal portion of the tie is identified (this is the posterior tongue-tie). A small window in the central mucosa is made and the lateral mucosal walls of the posterior tongue-tie are released, taking care to not disturb the fascia of the underlying genioglossus muscle.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | All patients were in the same arm - this is a cohort study where the group serves as their own control. Patients who did not undergo the procedure were not included in this outcomes study. Receives: Procedure: Lingual Frenotomy and/or maxillary labial frenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nipple Pain
Using a visual analog scale, nipple pain is evaluated.
Measured: 1 week
Reflux/GERD
Using a validated questionnaire (i-GERQ-R)
Measured: 1 week
Breastfeeding efficiency
Volume of breastmilk ingested in a specific time frame calculated (mL/min)
Measured: 1 week
Breastfeeding self-efficacy
Uses the BSES-SF validated questionnaire
Measured: 1 week
Secondary outcomes (3)
Nipple Pain
Using a visual analog scale, nipple pain is evaluated.
Measured: 1 month
Reflux/GERD
Using a validated questionnaire (i-GERQ-R)
Measured: 1 month
Breastfeeding self-efficacy
Uses the BSES-SF validated questionnaire
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Oregon Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bobak Ghaheri, MD, The Oregon Clinic
- Investigators
- Bobak A Ghaheri, MD, Principal investigator, The Oregon Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642133
- Sponsor's protocol ID
- TOC ENT
- Status last verified
- Dec 2015
- First submitted
- 22 Dec 2015
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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 23523198Geddes 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 18573859Pransky SM, Lago D, Hong P. Breastfeeding difficulties and oral cavity anomalies: The influence of posterior ankyloglossia and upper-lip ties. Int J Pediatr Otorhinolaryngol. 2015 Oct;79(10):1714-7. doi: 10.1016/j.ijporl.2015.07.033. Epub 2015 Jul 31.
PubMed 26255605Ghaheri 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding Improvement Following Tongue-tie and Lip-tie Release: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02642133
- Acronym / sponsor ID
- TOC ENT
- Conditions
- Ankyloglossia, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- The Oregon ClinicUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Dec 2015 (estimated)
- 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.
This study is an observational study to determine outcomes of surgical release of tongue-tie and lip-tie in babies who are experiencing difficulty with breastfeeding.
Detailed description
Breastfeeding rates in the United States initiate at around 80%, but many mothers are unable to effectively breastfeeding because of problems with latch and suction generation. Previous studies have demonstrated how nipple pain is directly linked to ankyloglossia, but most of these studies are done with poor methodology.
Clinically, tongue-tie and lip-tie have correlate with numerous other symptoms besides nipple pain. These babies tend to be inefficient nursers, which can affect weight gain. Abnormal intake of air because of the poor latch/seal can lead to reflux symptoms. Finally, there is a significant psychological toll on mothers who want to breastfeed but cannot do so.
This study aims to prospectively analyze these outcomes by using validated tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Procedure: Lingual Frenotomy and/or maxillary labial frenectomyAll patients were in the same arm - this is a cohort study where the group serves as their own control. Patients who did not undergo the procedure were not included in this outcomes study. |
Who may qualify
- Ages
- 1 day to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy babies who are breastfeeding 0-12 weeks of age
Key exclusion criteria (5 listed)
- Serious comorbid conditions (heart, lung, brain)
- Prior maternal breast surgery
- Insufficient glandular tissue
- Previous tongue/lip surgery
- Twins/Triplets
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 Frenotomy and/or maxillary labial frenectomyThe procedure is performed with a 1064nm InGaAsP semiconductor diode laser which is a soft tissue laser with variable pulsed wave and wattage settings. The procedure was performed at 0.7-0.8 pulsed watts, 200 microseconds on and 100 microseconds off (actual wattage: 0.47 to 0.53 W) using a 300 micron laser fiber. The tongue is elevated using a grooved director while the laser tip is applied to the frenulum. If present, the anterior frenulum is divided until the submucosal portion of the tie is identified (this is the posterior tongue-tie). A small window in the central mucosa is made and the lateral mucosal walls of the posterior tongue-tie are released, taking care to not disturb the fascia of the underlying genioglossus muscle. | Procedure or surgery | Intervention |
Primary outcome
Nipple Pain
Time frame: 1 week
Using a visual analog scale, nipple pain is evaluated.
Reflux/GERD
Time frame: 1 week
Using a validated questionnaire (i-GERQ-R)
Breastfeeding efficiency
Time frame: 1 week
Volume of breastmilk ingested in a specific time frame calculated (mL/min)
Breastfeeding self-efficacy
Time frame: 1 week
Uses the BSES-SF validated questionnaire
3 secondary outcomes
Nipple Pain
Time frame: 1 month
Reflux/GERD
Time frame: 1 month
Breastfeeding self-efficacy
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Background: PubMed 23523198O'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.
- Background: PubMed 18573859Geddes 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.
- Background: PubMed 26255605Pransky SM, Lago D, Hong P. Breastfeeding difficulties and oral cavity anomalies: The influence of posterior ankyloglossia and upper-lip ties. Int J Pediatr Otorhinolaryngol. 2015 Oct;79(10):1714-7. doi: 10.1016/j.ijporl.2015.07.033. Epub 2015 Jul 31.
- Derived from this study: PubMed 27641715Ghaheri 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.
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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.
Bobak A Ghaheri, MD principal investigator
The Oregon Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Lingual Frenotomy and/or maxillary labial frenectomy in people with Ankyloglossia and Breastfeeding, 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 30 Dec 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nipple Pain (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02642133, which also lists 4 linked publications.
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 30 Dec 2015.