Vertical Ridge DeficiencyNCT06636084
Vertical and Horizontal Mandibular Ridge Augmentation Techniques
A study testing Guided bone regeneration (GBR) in people with Vertical Ridge Deficiency and Horizontal Ridge Deficiency, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to compare alveolar ridge augmentation outcomes of two types of membranes for vertical and horizontal mandibular ridge augmentation: Customized CAD/CAM Titanium Mesh versus Reinforced Perforated PTFE Mesh (RPM). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vertical Ridge Deficiency, Horizontal Ridge Deficiency
- What is being tested?
- Guided bone regeneration (GBR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 1 Jun 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Physical status according to the American Society of Anesthesiology (ASA) I or II, which includes patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
- Subjects having at least one free end saddle edentulous area of the posterior area of the mandible with moderate horizontal and vertical bone defects >≥3mm.
- Capacity to understand and accept the written conditions of the study.
Who cannot join
- Insufficient oral hygiene.
- Smoking habit of >10 cigarettes/day (self-reported).
- Abuse of alcohol or drugs.
- Pregnancy or individuals attempting to get pregnant (self-reported).
- Acute local or systemic infections.
- Uncontrolled diabetes or other metabolic disease.
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- Severe hepatic or renal dysfunction.
- Autoimmune disorders.
- Patients who underwent radiotherapy in the last 5 years.
- Patients undergoing immunosuppressive therapy or who are immunocompromised.
- Any other contraindications for undergoing surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
Official title: Vertical and Horizontal Mandibular Ridge Augmentation Techniques: A Randomized Controlled Clinical Trial Comparing Customized CAD/CAM Titanium Mesh Versus Reinforced Perforated PTFE Mesh
The purpose of this study is to compare alveolar ridge augmentation outcomes of two types of membranes for vertical and horizontal mandibular ridge augmentation: Customized CAD/CAM Titanium Mesh versus Reinforced Perforated PTFE Mesh (RPM).
- Being tested
- Guided bone regeneration (GBR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided bone regeneration (GBR)Procedure or surgery
A composite graft composed of a 50:50 proportion of autogenous bone and a demineralized bone mineral will be positioned around the bony defect or placed in the membrane, depending on the group randomization. The selected membrane will then be secured with screws to ensure a complete and stable coverage of the grafted area.
| Study group | Role | What they receive |
|---|---|---|
| Customized CAD/CAM Titanium Mesh | Experimental | A customized CAD/CAM Titanium Mesh will be used to cover the bone graft Receives: Procedure: Guided bone regeneration (GBR) |
| Reinforced Perforated PTFE Mesh (RPM) | Active comparator | A Reinforced Perforated PTFE Mesh membrane will be used to cover the bone graft Receives: Procedure: Guided bone regeneration (GBR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ridge width changes in mm
Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements
Measured: 6 months
Ridge height changes in mm
Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements
Measured: 6 months
Secondary outcomes (5)
Change in the mucosal thickness in mm
Change in the mucosal thickness due to the provided space from baseline to the surgical mesh removal using an ultrasound
Measured: 6 months
Histological outcomes of the augmented bone
In terms of the amount of newly formed vital bone, residual graft particles, and connective tissue (CT)/other non-mineralized tissue components as a percentage
Measured: 6 months
The volumetric bone gain of the grafted area in mm3
Radiographic changes of bone volume based on cone-beam computed tomography (CBCT) scan measurements
Measured: 6 months
Rate of complications
Percentage that had complications associated with each technique
Measured: 6 months
Cost analysis
Difference in cost-effectiveness in dollars
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertical Ridge DeficiencyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan
- Investigators
- Hom-Lay Wang, DDS MSD PhD, Principal investigator, Department of Periodontics and Oral Medicine, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636084
- Sponsor's protocol ID
- HUM00262750
- Status last verified
- Jul 2025
- First submitted
- 8 Oct 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertical and Horizontal Mandibular Ridge Augmentation Techniques: A Randomized Controlled Clinical Trial Comparing Customized CAD/CAM Titanium Mesh Versus Reinforced Perforated PTFE Mesh
- ClinicalTrials.gov ID
- NCT06636084
- Acronym / sponsor ID
- HUM00262750
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 10 Oct 2024 (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 compare alveolar ridge augmentation outcomes of two types of membranes for vertical and horizontal mandibular ridge augmentation: Customized CAD/CAM Titanium Mesh versus Reinforced Perforated PTFE Mesh (RPM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customized CAD/CAM Titanium Mesh | Experimental | Procedure: Guided bone regeneration (GBR)A customized CAD/CAM Titanium Mesh will be used to cover the bone graft |
| Reinforced Perforated PTFE Mesh (RPM) | Active comparator | Procedure: Guided bone regeneration (GBR)A Reinforced Perforated PTFE Mesh membrane will be used to cover the bone graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Physical status according to the American Society of Anesthesiology (ASA) I or II, which includes patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
- Subjects having at least one free end saddle edentulous area of the posterior area of the mandible with moderate horizontal and vertical bone defects >≥3mm.
- Capacity to understand and accept the written conditions of the study.
Key exclusion criteria (11 listed)
- Insufficient oral hygiene.
- Smoking habit of >10 cigarettes/day (self-reported).
- Abuse of alcohol or drugs.
- Pregnancy or individuals attempting to get pregnant (self-reported).
- Acute local or systemic infections.
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 |
|---|---|---|
| Guided bone regeneration (GBR)A composite graft composed of a 50:50 proportion of autogenous bone and a demineralized bone mineral will be positioned around the bony defect or placed in the membrane, depending on the group randomization. The selected membrane will then be secured with screws to ensure a complete and stable coverage of the grafted area. | Procedure or surgery | Customized CAD/CAM Titanium Mesh, Reinforced Perforated PTFE Mesh (RPM) |
Primary outcome
Ridge width changes in mm
Time frame: 6 months
Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements
Ridge height changes in mm
Time frame: 6 months
Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements
5 secondary outcomes
Change in the mucosal thickness in mm
Time frame: 6 months
Histological outcomes of the augmented bone
Time frame: 6 months
The volumetric bone gain of the grafted area in mm3
Time frame: 6 months
Rate of complications
Time frame: 6 months
Cost analysis
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
Related trials for Vertical Ridge Deficiency
RecruitingObservational study
Digital Planning and Clinical Assessment of the Treated Atrophic Posterior Maxilla With a Sinus Lift Procedure: a Cross-sectional Study.
Alveolar Bone Atrophy, Alveolar Bone Grafting
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.
Hom-Lay Wang, DDS MSD PhD principal investigator
Department of Periodontics and Oral Medicine, University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided bone regeneration (GBR) in people with Vertical Ridge Deficiency and Horizontal Ridge Deficiency, run by University of Michigan 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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 25 Jul 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Ridge width changes in mm (time frame: 6 months). The study lists 2 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 25 Jul 2025; AzTrials last refreshed its copy on 28 Oct 2026.