Dynamic Effect of Occlusal Vertical Dimension on Lower Facial Form and Lip Positions

Обзор

The purpose of this study is to evaluate the effect of increased/decreased occlusal vertical dimension (OVD) on lower facial form and lip position, to analyze variations across gender groups and to analyze variations across age groups.

Вмешательства

• Устройство Occlusal Vertical Dimension Modification (-4mm)
  Participants will undergo fabrication and placement of removable bite splints designed to alter occlusal vertical dimension (OVD). On each side, four discrete reference points will be marked at the lowest point of the orbital margin and the highest point of the external auditory meatus using Whip-Mix reference plane marker.The subject's head position will be leveled with EZ bow laser level device and -4mm OVD color coded bite splints will be randomly placed in position. An image with desktop fac
• Устройство Occlusal Vertical Dimension Modification (-2 mm)
  Participants will undergo fabrication and placement of removable bite splints designed to alter occlusal vertical dimension (OVD). On each side, four discrete reference points will be marked at the lowest point of the orbital margin and the highest point of the external auditory meatus using Whip-Mix reference plane marker.The subject's head position will be leveled with EZ bow laser level device and -2mm OVD color coded bite splints will be randomly placed in position. An image with desktop fac
• Устройство Occlusal Vertical Dimension Modification (0 mm)
  Participants will undergo fabrication and placement of removable bite splints designed to alter occlusal vertical dimension (OVD). On each side, four discrete reference points will be marked at the lowest point of the orbital margin and the highest point of the external auditory meatus using Whip-Mix reference plane marker.The subject's head position will be leveled with EZ bow laser level device and 0mm OVD color coded bite splints will be randomly placed in position. An image with desktop faci
• Устройство Occlusal Vertical Dimension Modification (+2mm)
  Participants will undergo fabrication and placement of removable bite splints designed to alter occlusal vertical dimension (OVD). On each side, four discrete reference points will be marked at the lowest point of the orbital margin and the highest point of the external auditory meatus using Whip-Mix reference plane marker.The subject's head position will be leveled with EZ bow laser level device and +2mm OVD color coded bite splints will be randomly placed in position. An image with desktop fac
• Устройство Occlusal Vertical Dimension Modification (+4mm)
  Participants will undergo fabrication and placement of removable bite splints designed to alter occlusal vertical dimension (OVD). On each side, four discrete reference points will be marked at the lowest point of the orbital margin and the highest point of the external auditory meatus using Whip-Mix reference plane marker.The subject's head position will be leveled with EZ bow laser level device and +4mm OVD color coded bite splints will be randomly placed in position. An image with desktop fac

Первичные конечные точки

• Maxillary central incisor length [Срок оценки: From time of denture placement to about 24 hours after denture placement (depending on patient availibity)]
• Interlabial gap height [Срок оценки: From time of denture placement to about 24 hours after denture placement (depending on patient availability)]
• Intercommisural width [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Distance from Maxillary incisal edge to upper lip in millimeters [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Distance from Maxillary incisal edge to lower lip in millimeters [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Upper lip length [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Upper lip vermilion height [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Lower lip vermilion height [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• The upper lip margin on the central incisor to the gingival margin of maxillary central incisor [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• The lower lip margin on the central incisor to the gingival margin of mandibular central incisor [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]

Вторичные конечные точки (10)

• Maxillary central incisor length [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Interlabial gap height [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Intercommisural width [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Maxillary incisal edge to upper lip [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Maxillary incisal edge to lower lip [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Upper lip length [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Upper lip vermilion height [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Lower lip vermilion height [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• The upper lip margin on the central incisor to the gingival margin of maxillary central incisor [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]
• The lower lip margin on the central incisor to the gingival margin of mandibular central incisor [Срок оценки: denture placement to about 24 hours after denture placement (depending on patient availability)]

Критерии участия

Критерии включения

-Complete edentulous with complete dentures or overdentures

Критерии исключения

• Gross facial asymmetry
• A history of surgery in the facial area
• A history of neurologic disorders
• Ill-fitting dentures
• Dentures with inaccurate occlusal vertical dimension (OVD)
• Inability or unwillingness to smile
• Allergy to nitrile, vinyl polysiloxane (VPS) material or photopolymer resins.
• Presence of facial hair that would interfere with marking reference points on the face
• Severe class II or class III malocclusion

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at houston — Houston

Идентификаторы

NCT: NCT07491640 · HSC-DB-26-0081

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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