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NCT Number: NCT07491640

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

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.

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Key information

Conditions

Assessment of Vertical Dimension Change

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occlusal Vertical Dimension Modification (-4mm)

Device

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 facial scanner will be taken.

Occlusal Vertical Dimension Modification (-2 mm)

Device

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 facial scanner will be taken.

Occlusal Vertical Dimension Modification (0 mm)

Device

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 facial scanner will be taken.

Occlusal Vertical Dimension Modification (+2mm)

Device

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 facial scanner will be taken.

Occlusal Vertical Dimension Modification (+4mm)

Device

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 facial scanner will be taken.

Primary outcomes

  1. Maxillary central incisor length

    Time frame: From time of denture placement to about 24 hours after denture placement (depending on patient availibity)

  2. Interlabial gap height

    Time frame: From time of denture placement to about 24 hours after denture placement (depending on patient availability)

  3. Intercommisural width

    Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)

  4. 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)

  5. 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)

  6. Upper lip length

    Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)

  7. Upper lip vermilion height

    Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)

  8. Lower lip vermilion height

    Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)

  9. 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)

  10. 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 outcomes

  1. Maxillary central incisor length

    Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)

  2. Interlabial gap height

    Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)

  3. Intercommisural width

    Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)

  4. Maxillary incisal edge to upper lip

    Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)

  5. Maxillary incisal edge to lower lip

    Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)

  6. Upper lip length

    Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)

  7. Upper lip vermilion height

    Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)

  8. Lower lip vermilion height

    Time frame: denture placement to about 24 hours after denture placement (depending on patient availability)

  9. 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)

  10. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Chun-Yeh Chien

CONTACT

[email protected]

(713) 486-4274

Maria D Gonzalez, DDS, MS

CONTACT

[email protected]

(713) 486-4577

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.