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

Overview

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.

Interventions

• Device 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
• Device 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
• Device 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
• Device 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
• Device 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

Primary outcome measures

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

Secondary outcome measures (10)

• Maxillary central incisor length [Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Interlabial gap height [Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Intercommisural width [Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Maxillary incisal edge to upper lip [Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Maxillary incisal edge to lower lip [Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Upper lip length [Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Upper lip vermilion height [Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)]
• Lower lip vermilion height [Time frame: 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 [Time frame: 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 [Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)]

Eligibility criteria

Inclusion criteria

-Complete edentulous with complete dentures or overdentures

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Other

Study locations

United States · 1 center

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

Identifiers

NCT: NCT07491640 · HSC-DB-26-0081

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗