Manual Manipulation for Tongue-tie

Overseen By Emily A Clementi, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Georgetown University

Disqualifiers: Older than 90 days, Bottle fed, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2-3 weeks

110 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized control trial is to determine the impact of post-frenotomy manual manipulation on revision rates and breastfeeding outcomes. We hypothesize that post-frenotomy manipulation will reduce the rate of sublingual frenulum regrowth, and subsequently frenotomy revision rates, thereby improving breastfeeding performance. Infants with ankyloglossia undergoing frenotomy will be randomized into two groups: the intervention group (post-frenotomy manipulation) and the control group (no intervention). Parents in the intervention group will be instructed to perform tongue stretching and suck "re-training" exercises four times daily for 2-3 weeks, beginning 24 hours post-procedure. To monitor adherence and assess any complications, investigators will conduct a follow-up phone call one week after the procedure. Parents in the control group will not be instructed to perform any post-procedural manipulation. All participants will have a mandatory in-person follow-up 2-3 weeks postoperatively, during which breastfeeding outcomes and the need for frenotomy revision will be evaluated.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Post-frenotomy manual manipulation for tongue-tie?

There is no published evidence or clinical consensus supporting the effectiveness of post-frenotomy manual manipulation for improving breastfeeding or reducing recurrence in infants with tongue-tie. ^{1 2 3 4 5}

Is manual manipulation after frenotomy for tongue-tie safe?

There is no specific safety data on manual manipulation after frenotomy, but frenotomy itself is generally safe with rare complications like minor bleeding. ^{1 5 6 7 8}

How does manual manipulation for tongue-tie differ from other treatments?

Manual manipulation for tongue-tie is unique because it involves physical techniques to address the condition, unlike surgical options like frenotomy, which involves cutting the frenulum. This approach may be considered when looking for non-surgical alternatives, although there is limited evidence on its effectiveness compared to established surgical methods. ^{1 4 6 8 9}

Research Team

Earl H Harley, MD

Principal Investigator

MedStar Georgetown University Hospital

Eligibility Criteria

This trial is for infants with ankyloglossia, commonly known as tongue-tie, who are undergoing a frenotomy to improve breastfeeding. Infants must be eligible for the procedure and have parents willing to follow post-procedure instructions or not, depending on group assignment.

Inclusion Criteria

My baby is under 90 days old, has tongue-tie, and will have a simple outpatient procedure to fix it. We plan to breastfeed.

Exclusion Criteria

Infants who will be exclusively bottle fed

My baby was born before 36 weeks of pregnancy.

Infants with congenital anomalies or medical conditions affecting breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants undergo frenotomy and are randomized into intervention or control groups. Intervention group parents perform tongue stretching and suck 're-training' exercises for 2-3 weeks.

2-3 weeks

1 visit (in-person)

Follow-up

A follow-up phone call is conducted one week post-procedure to monitor adherence and assess complications.

1 week

1 visit (virtual)

Postoperative Evaluation

Mandatory in-person follow-up 2-3 weeks postoperatively to evaluate breastfeeding outcomes and need for frenotomy revision.

2-3 weeks

1 visit (in-person)

Treatment Details

Interventions

• Post-frenotomy manual manipulation

Trial Overview The study tests if manual manipulation after a frenotomy can reduce the need for another surgery by preventing regrowth of the tongue's frenulum. Half of the babies will receive this extra care while the other half won't, to see if it makes a difference in breastfeeding success.

Participant Groups

Group I: Exercise Group Experimental Treatment 1 Intervention

In the treatment group, parents will be instructed to perform postprocedural manipulation after the frenotomy.

Group II: Control Group Active Control 1 Intervention

In the control group, parents will not receive any instructions to perform "suck re-training" exercises or stretching following the procedure.

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

Findings from Research

A study involving 599 infants assessed the effects of post-frenotomy massage on breastfeeding success and recurrence of tongue-tie, finding no significant differences between those who received massage and those who did not.

Both breastfeeding rates and recurrence of tongue-tie were similar in both groups, indicating that post-frenotomy massage does not provide additional benefits, which can guide clinicians in advising parents against this practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post Frenotomy Massage for Ankyloglossia in Infants-Does It Improve Breastfeeding and Reduce Recurrence? Bhandarkar, KP., Dar, T., Karia, L., et al.[2022]

A 23-year-old male with a severe tongue-tie (Kotlows class III) underwent successful treatment using functional frenuloplasty with a diode laser, which minimized risks associated with traditional surgical methods.

The combination of laser surgery and orofacial myofunctional therapy showed promising long-term results, addressing issues related to speech and tongue mobility without significant complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of ankyloglossia by functional frenuloplasty using diode laser. Cherian, D., Saeed, R., Anusha, K., et al.[2023]

A scoping review and meta-analysis of 50 articles identified 7 studies that showed surgical and rehabilitative procedures for releasing tongue-tie in non-infants significantly improve tongue anatomy and functionality.

The use of validated assessment tools before and after the frenulum release is crucial, as it demonstrates clear clinical and functional improvements, emphasizing the need for their consistent application in both research and clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of tongue-tie release by means of tongue and frenulum assessment tools: a scoping review on non-infants. Arena, M., Micarelli, A., Guzzo, F., et al.[2023]

In a study of 37 children with ankyloglossia and articulation difficulties, both simple frenotomy and 4-flap Z-frenuloplasty resulted in significant improvements in speech articulation after 3 months, indicating both methods are effective surgical options.

There was no significant difference in speech outcomes between the two surgical techniques, suggesting that either method can be used effectively to treat tongue-tie in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of simple frenotomy with 4-flap Z-frenuloplasty in treatment for ankyloglossia with articulation difficulty: A prospective randomized study. Kim, TH., Lee, YC., Yoo, SD., et al.[2022]

Frenotomy, a procedure to correct tongue tie, has been associated with improvements in maternal nipple pain, breastfeeding self-efficacy, and LATCH scores in breastfeeding mothers, indicating potential benefits for the mother-infant dyad.

However, there is a lack of comprehensive data on how frenotomy affects the infant's feeding abilities, and the measures used to assess feeding quality in existing studies are not robust, highlighting the need for better research methodologies in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms of problematic feeding in infants under 1 year of age undergoing frenotomy: A review article. Hill, RR., Pados, BF.[2021]

In a study of 329 patients who underwent frenotomy, 60% of infants experienced breastfeeding difficulties due to tongue-tie, with symptoms including inadequate latch and painful nipples for mothers.

After the procedure, 86% of patients reported short-term improvement, and 82% reported long-term improvement, indicating that frenotomy is a safe and effective treatment for tongue-tie-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frenotomy for tongue-tie (frenulum linguae breve) showed improved symptoms in the short- and long-term follow-up. Ramoser, G., Guóth-Gumberger, M., Baumgartner-Sigl, S., et al.[2020]

Frenotomy, a surgical procedure to release the tongue-tie, is increasingly performed for infants with feeding difficulties, but current classifications of tongue-tie do not reliably predict these problems or the outcomes of the surgery.

New anatomical insights suggest that frenotomy may carry risks, highlighting the need for a thorough multidisciplinary evaluation of feeding issues before proceeding with the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primum non nocere: lingual frenotomy for breastfeeding problems, not as innocent as generally accepted. Van Biervliet, S., Van Winckel, M., Vande Velde, S., et al.[2021]

Breastfeeding issues, such as nipple pain and latching difficulties, are widely accepted as clinical signs that may warrant a frenotomy for tongue-tie, while the mere presence of a visible frenulum is not sufficient for diagnosis.

Frenotomy, a simple procedure to snip the frenulum, has rare complications, primarily minor bleeding, but the long-term effects of this procedure and the significance of posterior tongue-tie remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neonatal tongue-tie: myths and science]. Dollberg, S., Botzer, E.[2011]

A study involving 109 infants assessed the impact of lingual frenotomy on breastfeeding patterns, revealing that after the procedure, the number of sucks increased and the pause length between sucking decreased, indicating improved breastfeeding efficiency.

Mothers reported significant improvements in breastfeeding symptoms and coordination of sucking, swallowing, and breathing in infants who underwent frenotomy, while the control group showed no changes in their breastfeeding patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of frenotomy on breastfeeding. Martinelli, RL., Marchesan, IQ., Gusmão, RJ., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Post Frenotomy Massage for Ankyloglossia in Infants-Does It Improve Breastfeeding and Reduce Recurrence? [2022]

2. India pubmed.ncbi.nlm.nih.gov

Management of ankyloglossia by functional frenuloplasty using diode laser. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

Outcomes of tongue-tie release by means of tongue and frenulum assessment tools: a scoping review on non-infants. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Comparison of simple frenotomy with 4-flap Z-frenuloplasty in treatment for ankyloglossia with articulation difficulty: A prospective randomized study. [2022]

5. Norway pubmed.ncbi.nlm.nih.gov

Symptoms of problematic feeding in infants under 1 year of age undergoing frenotomy: A review article. [2021]

6. Norway pubmed.ncbi.nlm.nih.gov

Frenotomy for tongue-tie (frenulum linguae breve) showed improved symptoms in the short- and long-term follow-up. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Primum non nocere: lingual frenotomy for breastfeeding problems, not as innocent as generally accepted. [2021]

8. Israel pubmed.ncbi.nlm.nih.gov

[Neonatal tongue-tie: myths and science]. [2011]

9. Brazil pubmed.ncbi.nlm.nih.gov

The effects of frenotomy on breastfeeding. [2018]