Manual Manipulation for Tongue-tie

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether specific tongue exercises after a frenotomy (a procedure to correct tongue-tie) can improve breastfeeding. The study aims to determine if these exercises, known as post-frenotomy manual manipulation, can prevent the recurrence of tongue-tie and reduce the need for additional procedures. Infants under 90 days old with tongue-tie who are breastfeeding are suitable candidates for this trial. Parents in the exercise group will learn to perform tongue stretches and sucking exercises with their baby, while the control group will not engage in these exercises. The goal is to assess whether these exercises ease breastfeeding and decrease the likelihood of needing another frenotomy. As an unphased trial, this study provides parents an opportunity to contribute to understanding how post-frenotomy exercises might enhance breastfeeding outcomes.

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 prior data suggests that this manual manipulation is safe for infants?

Research has shown that tongue exercises after a frenotomy might be safe, but specific safety information remains limited. Some studies suggest these exercises can help with feeding problems and prevent the tissue under the tongue from regrowing, potentially avoiding the need for another procedure. However, not all experts agree. Some believe these exercises might not be helpful and could even cause problems. The frenotomy itself is generally considered safe. While the exercises might offer benefits, a complete picture of their safety is still lacking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about post-frenotomy manual manipulation for tongue-tie because it introduces a potentially beneficial technique following the standard frenotomy procedure. Unlike the typical approach, where no specific post-procedure exercises are performed, this method involves parents actively engaging in manipulation exercises. This could enhance healing and improve outcomes by promoting better tongue mobility and function. By focusing on post-surgical care, researchers hope to discover if these exercises can reduce complications and improve long-term results for infants with tongue-tie.

What evidence suggests that post-frenotomy manual manipulation is effective for reducing frenotomy revision rates and improving breastfeeding outcomes?

This trial will compare the effects of post-frenotomy manual manipulation exercises with no intervention. Studies have shown that exercises with a baby's tongue after a frenotomy (a procedure to cut a tight band of tissue under the tongue) can aid breastfeeding. These stretching exercises can ease feeding and reduce the chance of the tongue-tie returning, potentially preventing the need for another surgery. Research also suggests that these exercises can enhance the baby's mouth muscle function, making feeding more effective. Although experts may not all agree on the best frenotomy techniques, these exercises after the procedure have shown promise in improving outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Earl H Harley, MD

Principal Investigator

MedStar Georgetown University Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165587625000679

Outcomes of stretching exercises after lingual frenotomy in ... Stretching exercises improved patient-reported feeding difficulties, the development of recurrent frenulum, scarring, and need for revision procedure.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40010205/

Outcomes of stretching exercises after lingual frenotomy in ... Stretching exercises improved patient-reported feeding difficulties, the development of recurrent frenulum, scarring, and need for revision ...

3. ejpd.eu ejpd.eu/pdf/EJPD_2023_1885.pdf

Orofacial-Myofunctional therapy after lingual frenectomy in ... The same study shows an improvement of the electromyographic potential, suggesting a clinical improvement of muscular functions after treatment.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12384705/

Readhesion of Tongue-Tie Following Neonatal Frenotomy Post-frenotomy exercises help to reduce the readhesion rate. However, its importance is lower for symptomatic readhesion, although they are ...

5. enttoday.org enttoday.org/article/otolaryngologists-are-still-debating-the-effectiveness-of-tongue-tie-treatment/4/

Otolaryngologists Are Still Debating the Effectiveness of ... There is insufficient evidence to support claims that one technique of frenotomy, such as laser, is superior to other techniques.

6. publications.aap.org publications.aap.org/pediatrics/article/154/2/e2024067605/198022/Identification-and-Management-of-Ankyloglossia-and

Identification and Management of Ankyloglossia and Its ... Postfrenotomy stretching exercises in which the parents open the wound several times to prevent reattachment are not recommended and may cause ...

7. mdpi.com mdpi.com/2227-9067/12/8/971

Readhesion of Tongue-Tie Following Neonatal Frenotomy Our data suggest that diligent performance of postoperative tongue exercises reduced the incidence of tongue-tie readhesion and may have also reduced symptoms, ...

8. withpower.com withpower.com/trial/phase-ankyloglossia-9-2024-8e35e

Manual Manipulation for Tongue-tie Is manual manipulation after frenotomy for tongue-tie safe? There is no specific safety data on manual manipulation after frenotomy, but frenotomy itself is ...