The right fit: Bringing science to pacifier sizing
by David Tesini DMD, MS FDS RCSED
Clive Friedman DDS Diplomate AAPD, FiADH , FSCD
Technological innovations developed for babies and toddlers often find their applications in the field of special patient care later down the line. The word just doesn’t filter out or the application is not immediately clear. There are two advancements that will help in the diagnosis and prevention of compounding problems of the cranio-facial-dental and respiratory complex. Two new apps —Pacified and Gnathic-Click (coming soon) — help diagnose and prevent cranio-facial-dental and respiratory issues and make an immediate impact for parents, pediatric dentists, oral therapists, developmental specialists, and more.
There are products for caries control. There are interventions for behavior facilitation, tethered tissues, and trauma prevention. There are assessments for airway health, communication, swallowing and eating. None are as important as those developed for long term cranio-facial health of infants and toddlers. So, let’s begin where it starts — at birth.
Breastfeeding is beneficial to moms and babies, and it's one of many reasons the mandible’s long-term growth is so important. Parents give both breastfed and bottle-fed babies pacifiers, but often struggle with finding the right brand, design, and size since there’s no sizing standardization among the brands or retailers. That harmful categorization in chronological age size, claims of orthodontic benefits or recommendations for prolonged use are all playing out in class action lawsuits.
A too small or poorly designed pacifier can cause a crossbite and other orthodontic problems that last a lifetime. All pacifiers — whether labeled conventional or orthodontic3 — interact with the palate based on their fit (i.e., design and size).
Assessing the mandibular posture to determine retrognathic positioning (deficient jaw growth) or micrognathia (undersized lower jaw) is equally important. Historically, the provider’s clinical impression confirms suspected cases in infants and children. Although there is almost uniform agreement on early diagnosis, invasive imaging is rarely recommended if there are no visible syndromes.
Mandibular posture, whether true micrognathia or retrusion, is a predictive precursor to many health-related dysfunctions. There is much research and attention surrounding sleep disordered breathing now, that often the diagnosis and related treatments options lie in looking first at the effects of retrognathia on the airway of a growing child.
Biometric Pacifier Sizing
Philips Avent Ultra Soft Pacifier, image courtesy of Philips.
Pacifier sizes vary from 12.5 mm to 25.0 mm, but many baby product companies mistakenly think that the same size is interchangeable across chronological age stages. Chronological age is not a size metric. Peer reviewed research shows that the existing size concept of the investigated pacifiers does not indicate a growth pattern in any of their dimensions, as observed in normally growing preterm and term palates. Therefore, it cannot be considered physiological.6 Anatomical fit of the investigated pacifiers appeared undersized in their basic dimensions. Even if elastic deformation of the nipple and lips during sucking would be considered, there is no natural fit to the palate6.
Comfy Transparent Nuk, photo courtesy of Nuk.
A newborn’s palate needs support as it grows rapidly through the toddler years. That’s why the correct pacifier size is so important. The change to “biometric sizing” of pacifiers is the single most important thing that has happened to the baby product industry to improve the oral health of children. Advocacy for correct pacifier size is needed, and AAMS, AAPD, AADMD (and like-minded organizations) must call for biometric size labeling on all pacifier packaging.
Until recently, suppliers have paid little attention to pacifier sizing. Parents based their choice of pacifier (type, size, and brand) on arbitrary and outdated chronological age guidelines rather than contemporary facial biometrics.
Two new smartphone apps—Pacified and Gnathick-Click— solve this problem and eliminate the guesswork for parents with recommendations to improve children’s oral health. Recent scientific publications and the NEW Policy on Pacifier Use by the American Academy of Pediatric Dentistry (AAPD) has solidified the place of biometrics in infant feeding and soothing categories5.
What is the Pacified® app?
Pacified as an app developed by Toothprints PC, a Hopkinton, MA company and the leader in using facial biometrics to design products for the baby product industry. The app encourages the proper sizing of pacifiers. (Figure 1) The company is pushing suppliers back to the science so they can leave chronological sizing behind.
They want the industry leaders to appreciate that palatal support and free mandibular movement during non-nutritive sucking (NNS) are important in baby/toddler oral health and oro-facial development.3 Simply, a too small pacifier bulb and restrictive pacifier shield can contribute to palatal collapse and improper mandibular and airway development (Figure 3). This becomes even more important in the child with disabilities where sensory issues may impede normal development.
Using the app takes under two minutes. Parents enter a few demographics like age, weight, and ethnicity, then take a quick photo of the toddler’s face. The Pacified app scans and quantifies the anthropometric measurements. Then its proprietary, patented algorithm matches known facial correlations to the baby’s mouth size, then recommends a properly sized pacifier and a pacifier with a biometric or flat shield.
This data would certainly have value for other baby products, as the science of biometrics is also being demanded in the design of sippy cups and teethers. For example, for designing the circumference of the rim of an open drinking cup to the width of the baby/toddler mouth or compressive areas on teethers adapted to whether teeth are erupting or present The struggles of the parents of CSHCN to get them transitioning from soft to solid foods and the art of chewing, or the often difficult task of drinking from an open cup.
What is the Gnathic-Click™ app?
This soon-to-hit-the-market, first-generation app is designed to evaluate retrognathia and growth. Still in development, it is a complementary app to Pacified® and can help identify mandibular retrognathia early in life and provide a metric to monitor growth. The co-existence of micrognathia and mandibular retrusion with other conditions has received little attention in non-syndromic patients. These include feeding difficulty, oromyofunctional problems, orthodontic development, airway concerns and possibly long-term sleep issues. Clinical diagnosis is often reduced to our “clinical impression” to avoid invasive diagnostic procedures such as radiographs, CAT scans and/or other 3D imaging. Screening indices (mandibular and facial) used in these diagnostics help to define the maxillo-mandibular relationship.
Gnathic-click app algorithm incorporates four indices commonly used to define the retrognathic mandible, providing a reliable screening tool to identify the retrognathic grower from the time of birth. Its use will provide a metric to begin collection of data to help clinicians identify non-syndromic patients and act as a resource to determine outcomes of any intervention that may be prescribed.
The Gnathic app can define mandibular retrusion from a click of a smartphone to capture an oriented profile camera photo. It uses facial recognition of specified anthropometric points to calculate mandibular indices. The developed algorithm, from published facial anthropometrics, can also incorporate AI to allow prediction of facial growth (angles, linear measurements or volumetric). Periodic image comparisons from baseline through the toddler/preschool years can be compared to age specific standards7.
So why is this important? It will help in early diagnosis and early intervention through oromyofunctional therapy and orthodontics.
So why is this important? It will help in early diagnosis and early intervention through oromyofunctional therapy and orthodontics. It will encourage practitioners to look at comorbidities of the airway (SIDS/ ALTE/ BRUE and sleep apnea), breastfeeding difficulty, abnormal frenum anatomy and syndromic phenotypes. It will guide our recommendations for biometric pacifier shield design (mandibular offset) and help us to address parent’s esthetic concerns (Figure 3). It will sharpen our awareness of changes in the cranio-facial-dental respiratory system.
Advantages for the Practitioner
For the practitioner, the Gnathic-Click app is the progression from “It is my clinical impression?” to validation with contemporary smartphone technology. Neonatal clinical pediatric professionals and oro-myofunctional therapists have struggled to quantify the early diagnosis of micrognathia and mandibular retrusion without recommending the use of imaging. Although micrognathia has been understood to refer to size and retrognathia is defined as a receding chin in relation to the maxilla, both terms are mostly used interchangeably (Figure 4)
Table 1 presents a broad stroke review of the importance of mandibular anatomy and function in clinical diagnosis and treatment from an early age. All oro-motor behaviors find their origins in the postural stability and normal functioning of a well-developed and positioned mandible. Other research adds to our understanding that early perception and discriminatory abilities also develop during infancy and toddler years for food texture acceptance,8.9. As a child matures, the coordinated functioning of jaws, lips, breathing, tongue, TMJ, swallowing and functional aspects other oral structures (sometimes seemingly as small, tethered tissues) impacts feeding progression, swallowing, chewing, speech development, airway competence, tooth eruption, breathing and socialization. For CSHCN these challenging developmental milestones are particularly important in the presence of a micro gnathic or retrusive mandible. The earlier the diagnosis is made the earlier the treatment can begin; especially for those children with non-syndromic disabilities, sensory processing disorders and learning disabilities.
Table 1. Mandibular retrusion parameters and related dysfunctions
Clinical Parameters affected by Mandibular retrusion.
Related Cranio-facial
Dysfunctions of mandibular retrusion
Feeding mode: Breastfeeding /Bottle Feeding/
Abnormal masticatory function – eg swallowing air- inability to fully masticate
Diet texture - - Food Consistency
Can only tolerate soft diet without proper food progression
Difficulties and/or adaptations during sucking, feeding, airway - -
Inability to get adequate latch or control of nipple with either bottle or breast – with resultant aerophagia
Orofacial parafunctional habits
inability for tongue to touch palatal shelves
Face, Cheeks, Lips, Tongue, Esthetics (grouped as clinical observations)
Lip interposition and lingual retrusion of lower incisors and lip habit
Hard palate, soft palate, uvula
High vaulted palate – constricted arches
Posterior crossbites
Speech
Inability to articulate certain sounds- like
S, sh
Breathing (Airway)
Stretched forward posture of mandible and thus impacting overall posture and muscular activity – inability to maintain lip competency.
Scleral show and venous pooling around eyes indicative of sleep disorder
Deglutition
Bolus creation
Mastication
Decreased motricity and resultant swallowing of larger food particles
Hereditary Predisposition
long term growth – Dolichofacial patterning -steep mandibular plane, narrow palate
Hand to chin posture
Impact on long term growth – pressure on chin impeding/changing growth..
Frenum’s
Breast feeding, speech difficulty, palatal contact
Parental History of snoring (hereditary aspect)
Closure of post choana
The challenge for us, was to develop a tool to quantify our clinical impression to help us mitigate predisposing risk. We found that using the mandibular index11 we would achieve a reliable level of prediction to recommend that parents use a biometric shield design that would allow forward movement of the micrognathic infant mandible, unincumbered by the pacifier (i.e., shield) getting “sucked in” against the face during NNS and restricting growth of the mandible (Figure 2). Clinical neonatal micrognathia is associated with smaller upper airways often manifesting as OSA i.e., sleep apnea, ALTE, BRUE and SIDS during the first 6 months of life10,11. The risk of airway obstruction increases due to glossoptosis with higher mandibular index 12,13. Perhaps as Guilleminault observed, “Pediatric OSA in non-obese children is a disorder of oral-facial growth”. If diagnosed early, even simple oral intervention to correct persistent of abnormal tongue position (and associated abnormal breathing) by use of oral-facial exercises during feeding, and chewing may lead to correction of abnormal anatomy, resulting in repositioning of the tongue and development of a normal mandible14.
Conclusion
The development of these two technological advances using simple phone technology (and future AI) may be a definitive aid to the parent with a child who has a variety of special needs at birth. It is important that parents discuss these with their healthcare providers sooner, rather than later, without waiting for comorbid problems to develop.
The technological advances available now, must be accessible and applied to CSHCN in order to advantage this population to the lifetime value of early diagnosis through the use applications like Pacified and Gnathic-Click.
Another important advantage is that the use of these apps can bring attention to conditions often found in these children and thus highlight the need for interprofessional interventions.
References cited:
1 Tesini, D. A. (2022). Design, Sizing, and Ergonomics of Infant Pacifiers: A Biometric Basis for Pacifier Fit. Pediatric Nursing, 48(1), 36-41.
2 Sistenich, G.; Middelberg, C.; Stamm, T.; Dirksen, D.; Hohoff, (2022). Conformity between Pacifier Design and Palate Shape in Preterm and Term Infants Considering Age-Specific Palate Size, Facial Profile and Lip Thickness. Children, 9, 773.
3 BENSON and CAPARELLIL v. NEWELL BRANDS INC. and NUK USA LLC, Case: 1:19-cv-06836 Filed: 10/16/2019.
4 FREEMAN v. MAM U.S. Corp. Case: 1:20-cv-01834, Filed:3/23/2021. 528 F. Supp. 3d 849, (N.D. Ill. 2021)
5 American Academy of Pediatrics Task Force on Sudden Infant Death Syndrome. SIDS and other sleep-related infant deaths: Updated 2016 recommendations for a safe infant sleeping environment. Pediatrics 2016;138(5):e20162938
6 Tesini, D. A., Hu, L. C., Usui, B. H., & Lee, C. L. (2022). Functional comparison of pacifiers using finite element analysis. BMC Oral Health, 22(1), 49.
7 Subtelny, J. D. (1959). A longitudinal study of soft tissue facial structures and their profile characteristics, defined in relation to underlying skeletal structures. American Journal of Orthodontics, 45(7), 481-507
8Wilkinson 2001 From food structure to texture. Trends in Food Science & Technology 11 (2000) 442–450
9 Veneziano A, Irish JD, Meloro C, Stringer C, De Groote I. The functional significance of dental and mandibular reduction in Homo: A catarrhine perspective. Am J Primatol. 2019;e22953. 2019;81:e22953. https://doi.org/10.1002/ajp.22953 https://doi.org/10.1002/ajp.2295
10 Gunn, T. R., Tonkin, S. L., Hadden, W., Davis, S. L., & Gunn, A. J. (2000). Neonatal micrognathia is associated with small upper airways on radiographic measurement. Acta Paediatrica, 89(1), 82-87
11Luedders, D. W., Bohlmann, M. K., Germer, U., Axt‐Fliedner, R., Gembruch, U., & Weichert, J. (2011). Fetal micrognathia: objective assessment and associated anomalies on prenatal sonogram. Prenatal diagnosis, 31(2), 146-151.
12 Van Der Haven, I., Mulder, J. W., Van Der Wal, K. G., Hage, J. J., De Lange-De Klerk, E. S., & Haumann, T. J. (1997). The jaw index: new guide defining micrognathia in newborns. The Cleft palate-craniofacial journal, 34(3), 240-241
13 Horn, M. H., Kinnamon, D. D., Ferraro, N., & Curley, M. A. (2006). Smaller mandibular size in infants with a history of an apparent life-threatening event. The Journal of pediatrics, 149(4), 499-504
14 Huang Y and Guilleminault, C. (2013). Pediatric obstructive sleep apnea and the critical role of oral-facial growth: evidences. Frontiers in neurology, 3, 184.
Figure 1. Pacified® smartphone application for biometric sizing
Figure 2. Functional jaw and tongue activity during nutritive and non-nutritive sucking
(Page, D. (2001). Breastfeeding is early functional jaw orthopedics (an introduction). Functional Orthodontist, 18(3), 24-27.)
Figure 3 Biometric shield design of the TOMY/ Boon Jewl pacifier to allow free movement of the mandible.
Figure 4. Infant with “clinical impression” of mandibular retrusion
