Ankyloglossia

5

Review clinical trials related to Ankyloglossia. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Ankyloglossia and Breastfeeding

Ankyloglossia is a congenital condition characterized by a restrictive lingual frenulum that may limit normal tongue mobility and be associated with breastfeeding difficulties. Reported problems include ineffective latch, maternal nipple pain and nipple trauma, mastitis, reduced milk transfer, poor infant weight gain, and early breastfeeding cessation. However, the available evidence regarding the impact of ankyloglossia on breastfeeding outcomes remains limited and controversial. The primary objective of this prospective cohort study is to evaluate the association between neonatal ankyloglossia, assessed using the TABBY assessment tool during the first 72 hours of life, and breastfeeding effectiveness measured using the LATCH scale during the same period. Mother-infant dyads will be recruited during the newborn's first 72 hours of life, during the hospital admission for childbirth, at the University Hospital of Guadalajara, Spain. Newborns will be classified according to the presence or absence of ankyloglossia using the TABBY assessment tool and will be followed for the first 6 months of life. Information will be collected during routine clinical follow-up and through telephone interviews. The secondary objectives are to evaluate the association between ankyloglossia and breastfeeding duration, exclusive breastfeeding duration, maternal pain during breastfeeding, and maternal breastfeeding satisfaction.

Participants needed: 146
Trial details
Age: Up to 72Biological sex: AllType: ObservationalSponsor: Ariana Muñoz San MiguelUpdated: Aug 11, 2026Locations: 1
Eligibility criteria

Mother-infant dyads recruited during the newborn's first 72 hours of life, durin... [+4]

Birth outside the University Hospital of Guadalajara. [+7]

Status: Recruiting

The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes

This purpose of this study is to investigate whether performing sublingual massages after frenotomy reduces the recurrence of ankyloglossia (e.g., "tongue-tie". After consent from the parents or guardians, infants who received underwent frenotomy will be randomized to either complete sublingual massages according to a specified description and schedule, or they will be randomized to the control group where they will be instructed to perform no massages. The main question to answer is do these massages reduce the likelihood of tongue-tie recurrence or not. Secondary question is will there be any significant difference on feeding practice or experience in infants who undergo massages compared to those who do not.

Participants needed: 150
Trial details
Age: Up to 1Biological sex: AllType: InterventionalSponsor: Isaac ElijahUpdated: Aug 3, 2026Locations: 1
Eligibility criteria

Neonates (age <1 year) who were undergoing frenotomy procedure are eligible.

Patients will be excluded if they were older than 1 year, or had palatal or orop...

Status: Not yet recruiting

Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise

The P1821 initiative constitutes an innovative intervention specifically engineered to enhance tongue muscular strength and endurance. The primary objective of this research study is to ascertain whether the integration of a proactive tongue strengthening exercise regimen, utilizing a Non-Significant Risk (NSR) Device, contributes to an observable improvement in speech fluency.

Participants needed: 100
Trial details
Biological sex: AllType: InterventionalSponsor: Dream Video LLCUpdated: Jul 22, 2026Locations: 1
Eligibility criteria

Can read and write [+1]

Previously seen and treated by speech and language pathologist for dysphagia or... [+1]

Status: Recruiting

Healing Efficacy of Diode Laser in Lingual Frenectomy

This study aims to compare the wound healing efficacy and postoperative experiences between the 940 nm diode laser technique and the traditional electrosurgery method for treating ankyloglossia (tongue-tie) in children aged 3 to 6 years. Participants are randomly assigned to one of two groups: Experimental Group - Patients undergo lingual frenectomy using a 940 nm diode laser and Active Comparator Group - Patients undergo the procedure using conventional high-frequency electrosurgery. The study evaluates several key outcomes at multiple intervals (24 hours, 3 days, 1 week, and 1 month post-surgery), including: (1) Wound Healing: Measured by the Early Wound Healing Score (EHS); (2) Pain Levels: Assessed using the Wong-Baker FACES Pain Rating Scale; (3) Bleeding Control: Evaluation of intraoperative bleeding; (4) Tongue Mobility: Measurement of free tongue length according to Kotlow's classification. The goal is to determine if the diode laser provides superior healing, less pain, and better bleeding control compared to electrosurgery.

Participants needed: 53
Trial details
Age: 3-6Biological sex: AllType: InterventionalSponsor: University of Medicine and Pharmacy at Ho Chi Minh CityUpdated: Apr 30, 2026Locations: 2
Eligibility criteria

Patients aged between 3 and 6 years. [+3]

History of allergy to local anesthetics (e.g., Lidocaine, Adrenaline). [+3]

Status: Recruiting

Post-Procedural Manual Manipulation for Infant Ankyloglossia

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.

Participants needed: 110
Trial details
Age: Up to 90Biological sex: AllType: InterventionalSponsor: Georgetown UniversityUpdated: Feb 17, 2025Locations: 1
Eligibility criteria

infants less than 90 days old with ankyloglossia who undergo outpatient frenotom...

infants older than 90 days, those who will be exclusively bottle fed, infants wh... [+1]