Clinical Research Directory

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.

Tongue Mobility in Patients With Ankyloglossia Following Frenectomy

This observational study evaluated changes in tongue mobility among patients with ankyloglossia who underwent frenectomy as part of routine clinical care. The decision to perform frenectomy, including the indication and surgical technique, was made by the treating clinician independently of study participation. The study did not assign any treatment. Tongue mobility measurements obtained before treatment and during routine postoperative follow-up were analyzed.

Long-term Follow-up of Infant Frenotomy/Frenectomy Through Early Childhood

Ankyloglossia (tongue tie) is an anatomically shortened lingual frenum that impairs appropriate tongue mobility. Initial clinical diagnosis of tongue tie usually begins during infancy with abnormal breastfeeding though not all infants with a tongue tie may exhibit difficulties with breastfeeding. Breastfeeding may be impacted during both the latch and suckle phases. Normal latch requires anterior thrust of the tongue past the mandible with the tongue extending out inferior to the mother's nipple and breast. Normal suckle requires tongue elevation including along the entire palate to form sufficient suction force for milk expression from the breast. An tongue tie limiting anterior mobility may inhibit the ability of the tongue to extend anteriorly for appropriate latch, while a tongue tie limiting mid-tongue elevation may impeded the ability of the tongue to elevate to the palate and form sufficient suction force for appropriate suckle. In either situation, symptoms including poor latch, poor suckle, tiredness, extended feeding time, and for the mother nipple pain, tiredness, and frustration are common. To our knowledge there is no self-correction for ankyloglossia. The frenum does not disappear or become less restrictive on its own over time. Frequency of functional adaptation is now known. Prevalence of ankyloglossia ranges up to 16% depending on population studied, with averages hovering between 8-12%, with males more likely than females to have a tongue tie. While the prevalence of tongue tie has been studied, there is minimal research on the rate of frenectomy for patients with tongue tie. There is also minimal research on the long term effects of infant frenectomy, including on the indications/need for revision surgery for children experiencing difficulties in feeding/transition to solids, speech, malocclusion and/or sleep and breathing concerns. With the increasing popularity of frenectomy, especially in infants, long term research is necessary. However, due to the lack of existing research an initial observational trial to gather preliminary data to allow for more appropriate planning of future research is indicated.

SNIP follow-on Case Series Using v3 Device

Case series of infants with anterior ankyloglossia being treated by the Sublingual Neonatal Incision Platform device

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.

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.

Case Series of Infants With Anterior Ankyloglossia Being Treated by the Sublingual Neonatal Incision Platform Device

A study assessing the feasibility of a novel device designed specifically to treat infant tongue-tie.

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.

Ankyloglossia and Its Effects on Breastfeeding, Feeding and Speech Disorders. A Prospective Study From Birth to 4 Years of Age.

The diagnosis of ankyloglossia (restrictive lingual frenulum) and the number of frenotomies in infants have sharply increased, raising concerns among the medical community and the ONE. While some studies suggest benefits of frenotomy on breastfeeding, all emphasize the lack of consensus regarding the definition, diagnosis, and classification of ankyloglossia, as well as the scarcity of prospective data on its impact on breastfeeding, feeding, occlusion, and speech. This prospective study aims to determine whether lingual frenulum characteristics influence early breastfeeding difficulties and duration, as well as later feeding, occlusion, and speech outcomes. Breastfed newborns are followed from the first days of life (T1) to age 4 years (T7). During the first 3 months, tongue mobility, frenulum characteristics, breastfeeding, maternal pain, and complications are assessed. Several clinical tools are compared to identify the most reliable ones. Frenulum length is measured using calibrated photographs. Phone follow-ups at 6 months, 1 and 2 years assess feeding outcomes; speech and occlusion are evaluated at 4 years. This project could provide objective data to guide clinicians in evaluating ankyloglossia and making informed frenotomy decisions, improve breastfeeding support, and help parents make evidence-based choices.

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.

Frenuloplasty for Speech and Myofunctional Outcomes

Children with ankyloglossia (tongue tie) can have abnormal tongue function, putting them at a disadvantage when it comes to speech and articulation. Furthermore, abnormal tongue posture within the oral cavity increases the likelihood of myofunctional disorders.