BackgroundDetection of mandibular range of motion variations in infants may allow for early diagnosis of pathologic conditions to the temporomandibular joint. PurposeThe purpose of this study was to determine the normal ranges for maximal mouth opening (MMO) in healthy infants under 12 months of age. Study design, setting, sampleA single-group prospective cohort study of consecutive patients below 12 months of age was conducted in an outpatient setting at the Florida Craniofacial Institute in Tampa, Florida. Patients were excluded if they had trismus, presented with signs of obstructive sleep apnea, suffered a facial fracture, or were diagnosed with a craniofacial syndrome. Predictor/exposure/independent variableAge (in months) at the time of presentation, measured as a continuous variable. Main outcome variable(s)The main outcome variable was MMO. This was measured by placing a thumb and forefinger in the infant’s mouth and apply slight pressure to encourage maximal mouth opening. In older infants with erupted central incisors, MMO was measured from the gingival margins. CovariatesThe covariates were sex, race, and gestational age. AnalysesFindings were presented as means with 95% confidence intervals. A multivariate linear regression analysis was conducted to evaluate changes in MMO with increasing age. ResultsThe sample was composed of 151 infants with a mean age of 5.2 months (95% CI 4.8 to 5.6), and 33% were female. The mean MMO was 32.1 mm (95% CI 31.5 to 32.7). Results of the linear regression analysis showed MMO to significantly increase with increasing age, increasing at a mean rate of approximately 1 mm per month (coefficient 1.06, 95% CI 0.88 to 1.23, p<0.001). In neonates <1 month of age, the mean MMO was 22.0 mm (95% CI 20.4-23.6), compared to a mean of 36.7 mm (95% CI 34.8-38.6) in infants 11 months of age. Conclusions and RelevanceThe results of this study provide normative data of the association of age with MMO, which may be of value in assessing for infants with jaw mobility disorders.