98 Chapter 5 However, it was postulated that the study was limited by the fact that soft tissues of the cadavers were solidified by their embalmment in a formaldehyde solution, which would lead to a suboptimal approximation of the surface areas [3]. For this reason, in the current study we included living participants and we also applied an intra-oral scanner, which projects a light on intra-oral surfaces to be scanned. Then, images captured by imaging sensors are processed by scanning software to produce triangulated point clouds that enable a virtual 3D surface model to be created [7]. A recent study revealed promising results using this scanner, especially for the documentation of palatal soft tissue in terms of shape, colour, and curvature [9]. Therefore, this study was designed to validate the relationship between the palate surface area, measured using an intra-oral scanner, and anthropometric measurements of the head and face in living participants. A relation between the anthropomorphic measurements and the palatal intra-oral surfaces would enable easy estimation of the palatal intra-oral surface area in a chair-side medical setting. Determination of the palatal surface area might be relevant for clinicians investigating the oral cavity, such as dentists and oral maxillofacial surgeons. MATERIAL AND METHODS Participants The study was approved by the Ethics Review Committee at the Academic Centre for Dentistry Amsterdam (ACTA; 202065). Volunteers were recruited at ACTA through posters. Eligibility criteria required volunteers to be 18 years or older. Informed written consent was obtained from all volunteers. Data analysis of volunteers was completely anonymously, only age and sex were registered. The reporting of this study conforms to the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement [27]. A priori sample size calculation was performed using G*Power software, version 3.1.9.4 (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany); the correlation coefficient of previous study was used 0.59 [3], an α of 0.05, and a power of 80%, 20 participants were needed in each group. Because sex differences effect anthropometric of orofacial measures minimally 40 participants were needed with almost equal numbers of females and males [11, 21, 32].
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