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

March 18, 2026 updated by: Maria D Gonzalez, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Occlusal Vertical Dimension Modification (-4mm)
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 facial scanner will be taken.
Experimental: Occlusal Vertical Dimension Modification (-2 mm)
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 facial scanner will be taken.
Experimental: Occlusal Vertical Dimension Modification (0 mm)
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 facial scanner will be taken.
Experimental: Occlusal Vertical Dimension Modification (+2mm)
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 facial scanner will be taken.
Experimental: Occlusal Vertical Dimension Modification (+4mm)
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 facial scanner will be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maxillary central incisor length
Time Frame: From time of denture placement to about 24 hours after denture placement (depending on patient availibity)
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)
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)
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)
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)
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)
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)
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)
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)
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)
denture placement to about 24 hours after denture placement (depending on patient availability)

Secondary Outcome Measures

Outcome Measure
Time Frame
Intercommisural width
Time Frame: denture placement to about 24 hours after denture placement (depending on patient availability)
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)
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)
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)
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)
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)
denture placement to about 24 hours after denture placement (depending on patient availability)
Maxillary central incisor length
Time Frame: denture placement to about 24 hours after denture placement (depending on patient availability)
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)
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)
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)
denture placement to about 24 hours after denture placement (depending on patient availability)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Maria D Gonzalez, DDS, MS, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

June 19, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • HSC-DB-26-0081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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