Assessment of Vertical Dimension ChangeNCT07491640
Dynamic Effect of Occlusal Vertical Dimension on Lower Facial Form and Lip Positions
A study testing Occlusal Vertical Dimension Modification (-4mm), Occlusal Vertical Dimension Modification (-2 mm) and Occlusal Vertical Dimension Modification (0 mm) in people with Assessment of Vertical Dimension Change, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Assessment of Vertical Dimension Change
- What is being tested?
- Occlusal Vertical Dimension Modification (-4mm), Occlusal Vertical Dimension Modification (-2 mm) and Occlusal Vertical Dimension Modification (0 mm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Complete edentulous with complete dentures or overdentures
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at houston
Houston, Texas, 77030
About this study
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.
- Conditions
- Assessment of Vertical Dimension Change
- Being tested
- Occlusal Vertical Dimension Modification (-4mm), Occlusal Vertical Dimension Modification (-2 mm), Occlusal Vertical Dimension Modification (0 mm), Occlusal Vertical Dimension Modification (+2mm), Occlusal Vertical Dimension Modification (+4mm)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Occlusal Vertical Dimension Modification (-4mm) | Experimental | Not described Receives: Device: Occlusal Vertical Dimension Modification (-4mm) |
| Occlusal Vertical Dimension Modification (-2 mm) | Experimental | Not described Receives: Device: Occlusal Vertical Dimension Modification (-2 mm) |
| Occlusal Vertical Dimension Modification (0 mm) | Experimental | Not described Receives: Device: Occlusal Vertical Dimension Modification (0 mm) |
| Occlusal Vertical Dimension Modification (+2mm) | Experimental | Not described Receives: Device: Occlusal Vertical Dimension Modification (+2mm) |
| Occlusal Vertical Dimension Modification (+4mm) | Experimental | Not described Receives: Device: Occlusal Vertical Dimension Modification (+4mm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary central incisor length
Measured: From time of denture placement to about 24 hours after denture placement (depending on patient availibity)
Interlabial gap height
Measured: From time of denture placement to about 24 hours after denture placement (depending on patient availability)
Intercommisural width
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Distance from Maxillary incisal edge to upper lip in millimeters
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Distance from Maxillary incisal edge to lower lip in millimeters
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Upper lip length
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Upper lip vermilion height
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Lower lip vermilion height
Measured: 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
Measured: 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
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Secondary outcomes (10)
Maxillary central incisor length
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Interlabial gap height
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Intercommisural width
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Maxillary incisal edge to upper lip
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Maxillary incisal edge to lower lip
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Upper lip length
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Upper lip vermilion height
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Lower lip vermilion height
Measured: 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
Measured: 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
Measured: denture placement to about 24 hours after denture placement (depending on patient availability)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Jun 2026
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Vertical Dimension ChangeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will get all 5 sizes of splints and the order of receipt of each size will be randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria D Gonzalez, The University of Texas Health Science Center, Houston
- Investigators
- Maria D Gonzalez, DDS, MS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491640
- Sponsor's protocol ID
- HSC-DB-26-0081
- Status last verified
- Sep 2026
- First submitted
- 5 Mar 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Effect of Occlusal Vertical Dimension on Lower Facial Form and Lip Positions
- ClinicalTrials.gov ID
- NCT07491640
- Acronym / sponsor ID
- HSC-DB-26-0081
- Conditions
- Assessment of Vertical Dimension Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- All participants will get all 5 sizes of splints and the order of receipt of each size will be randomized
| Arm | Type | Receives |
|---|---|---|
| Occlusal Vertical Dimension Modification (-4mm) | Experimental | Device: Occlusal Vertical Dimension Modification (-4mm) |
| Occlusal Vertical Dimension Modification (-2 mm) | Experimental | Device: Occlusal Vertical Dimension Modification (-2 mm) |
| Occlusal Vertical Dimension Modification (0 mm) | Experimental | Device: Occlusal Vertical Dimension Modification (0 mm) |
| Occlusal Vertical Dimension Modification (+2mm) | Experimental | Device: Occlusal Vertical Dimension Modification (+2mm) |
| Occlusal Vertical Dimension Modification (+4mm) | Experimental | Device: Occlusal Vertical Dimension Modification (+4mm) |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Complete edentulous with complete dentures or overdentures
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Occlusal Vertical Dimension Modification (-4mm) |
| 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. | Device | Occlusal Vertical Dimension Modification (-2 mm) |
| 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. | Device | Occlusal Vertical Dimension Modification (0 mm) |
| 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. | Device | Occlusal Vertical Dimension Modification (+2mm) |
| 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. | Device | Occlusal Vertical Dimension Modification (+4mm) |
Primary outcome
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)
10 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Assessment of Vertical Dimension Change
Not yet recruiting
Occlusal Changes After Modified Hall Technique in Molars Affected by Molar-Incisor Hypomineralization
Dental Caries, Dental Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria D Gonzalez, DDS, MS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusal Vertical Dimension Modification (-4mm), Occlusal Vertical Dimension Modification (-2 mm) and Occlusal Vertical Dimension Modification (0 mm) in people with Assessment of Vertical Dimension Change, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxillary central incisor length (time frame: From time of denture placement to about 24 hours after denture placement (depending on patient availibity)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.