Manual Manipulation for Tongue-tie

Recruiting in Palo Alto (17 mi)

Overseen by Earl H Harley, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Georgetown University

Disqualifiers: Older than 90 days, Bottle fed, others

No Placebo Group

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}

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

Trial 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 (Behavioural Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery Washington, United States

Who Is Running the Clinical Trial?

Georgetown University Lead Sponsor

References

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

Post Frenotomy Massage for Ankyloglossia in Infants-Does It Improve Breastfeeding and Reduce Recurrence? [2022] Frenotomy is performed in breast fed infants who experience difficulty in latching after failed conservative management for ankyloglossia or tongue-tie. Though parents sometimes enquire about massage after frenotomy, neither published evidence nor clinical consensus supports this. The aim of our study was to assess if there was significant difference in breast feeding or recurrence rate between those infants who had post frenotomy massage and those who did not.

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

Management of ankyloglossia by functional frenuloplasty using diode laser. [2023] Ankyloglossia or tongue-tie is a condition present since birth that results in restricted movement of the tongue due to the attachment of the lingual frenulum. The condition affects breastfeeding, speaking, swallowing, occlusion, and proper tongue posture. Tongue ties vary in degree of severity from mild cases of mucus membrane bands to complete tongue ties where the tongue adheres to the floor of the mouth. Treatment options such as speech therapy, frenotomy,frenectomyhave all been suggested in the literature. Surgical correction often causes, bleeding,chances of infection, swelling, and relapse. A systemically healthy 23-year-old male patient who experienced difficulty in speech since childhood was referred for treatment to the dental clinic in September 2020. He was diagnosed with Kotlows class III tongue tie and angles class 3 malocclusion. Orthodontic correction and Functional frenuloplasty using a diode laser was carried out. In conjunction with it,orofacial myofunctional therapy was advised. Follow-up: The surgical procedure was uneventful. The patient was reviewed post-operatively at regular intervals every 3 months to check for relapse. This paper elaborates on the newer modes of diagnosis, orofacial myofunctional therapy, and lingual frenuloplasty with diode laser. This technique will help to overcome all the challenges of conventional tongue-tie treatments providing long-term excellent results.

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] To evaluate outcomes of the surgical and rehabilitative procedures devoted to release the tongue-tie in non-infants when implementing the most commonly used quantitative/qualitative structured tools for tongue and frenulum assessment.

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] To compare the surgical outcomes of simple frenotomy and the 4-flap Z-frenuloplasty according to the articulation test values and tongue-tie classification in patients with ankyloglossia with articulation difficulty.

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

Symptoms of problematic feeding in infants under 1 year of age undergoing frenotomy: A review article. [2021] The aims of this systematic review were to first identify and summarise original research that compared symptoms of problematic feeding in infants with tongue tie before and after frenotomy and then evaluate the quality of measures used to assess problematic feeding.

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] To evaluate clinical manifestations of tongue-tie as well as short-term and long-term outcomes following frenotomy.

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

Primum non nocere: lingual frenotomy for breastfeeding problems, not as innocent as generally accepted. [2021] The frenotomy or surgical release of the lingual frenulum is performed with increasing frequency. Restricted tongue mobility, ankyloglossia, is the main indication for this procedure. This clinical diagnosis is often used as synonym for tongue-tie which is blamed for many feeding difficulties resulting in an increase in performed frenotomies. Until recently, little was known about the anatomical structure and normal variation of the tongue-tie. Different grading systems have been developed. Some are exclusively based on appearance of the tongue-tie; others also include functional elements. There is, however, no established relation between the tongue-tie score and the observed feeding problems or outcomes following frenotomy. Therefore, caution is warranted before submitting babies to this procedure.Conclusion: This narrative review aims to give an overview of current knowledge and concerns regarding the tongue-tie, which need to be considered before referral for a frenotomy. What is Known: • The presence of a tongue-tie is associated with a higher frequency of breastfeeding problems. • Hence, frenotomy is advocated and increasingly performed in infants with breastfeeding problems. Current tongue-tie classifications do not allow to predict breastfeeding problems. What is New: • New anatomy insights caution for possible complications resulting from this seemingly innocent practice of frenotomy. • Frenotomy should only be performed after multidisciplinary evaluation of feeding problems, following exclusion and remediation of other causative factors.

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

[Neonatal tongue-tie: myths and science]. [2011] Anatomical restraining of tongue movement (tongue-tie, ankyloglossia) has been known for centuries and the subject of dozens of articles. The heated debate persists on its clinical significance and indications for treatment. Most authorities in the field of infant feeding and Lactation agree that breastfeeding problems, such as nipple pain and latching difficulties, are common signs of clinicaLly significant tongue-tie and indications for performing a frenotomy, while the sole presence of a visible lingual frenulum is not. In contrast, the lack of a visible frenulum does not rule out the diagnosis of clinically significant tongue-tie since submucosal ties, also called "posterior tongue-tie", may interfere with efficient breastfeeding. Whether tongue-tie interferes with speech articulation to a significant extent is currently unknown. Theoretically, articulation of some consonants (e.g., /s/, /th/, /r/) would be affected by impeded tongue movement. These articulation problems are, however, Less common than tongue-tie itself, and children and adults characteristically use various compensatory techniques of mouth opening and tongue movements. When it is indicated, frenotomy is performed by lifting the tongue and snipping the frenulum with scissors. Complications of frenotomy are rare and consist mainly of self-limited minor bleeding. The significance of posterior tongue tie and the long-term effects of frenotomy performed during early infancy are unresolved issues.

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

The effects of frenotomy on breastfeeding. [2018] Although the interference of tongue-tie with breastfeeding is a controversial subject, The use of lingual frenotomy has been widely indicated by health professionals.