Horizontal Ridge DeficiencyNCT07082244
Implant Phenotype Modification Via GBR and ADM
A study testing Dental implant placement, Guided bone regeneration with collagen membrane and Guided bone regeneration with acellular dermal matrix. in people with Horizontal Ridge Deficiency, run by University of Michigan at 1 site in United States.
Trial summary
Single implant sites with bone loss can often be managed by bone grafting alone. The purpose of this study is to determine whether putting a soft tissue graft substitute over the bone graft will provide an increased benefit for improving the health, appearance, and stability of the bone and gums surrounding the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Horizontal Ridge Deficiency
- What is being tested?
- Dental implant placement, Guided bone regeneration with collagen membrane and Guided bone regeneration with acellular dermal matrix.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Subjects with a physical status of systemically healthy or suffering from mild to moderate, but well-controlled disease; American Society of Anesthesiology (ASA) I or II.
- Subjects must have one edentulous region, with at least 3 months of healing post-extraction, in the esthetic zone of the maxilla or the premolar and canine region of the mandible. This region includes the maxillary premolars, canines, and incisors.
- Subjects must have a full mouth plaque and bleeding score of less than or equal to 20%, measured at four sites per tooth.
- The patients should have a thin periodontal phenotype; bucco-lingual ridge thickness greater than 6mm.
- Seibert class I deficiency (Seibert, 1983)
- Patients willing to sign the informed consent.
Who cannot join
- Presence of uncontrolled and/or untreated periodontal disease.
- Patients currently smoking cigarettes, cannabis, and electronic cigarettes.
- Subjects taking medications known to impact bone metabolism or have the capacity to affect wound healing. These drugs include bisphosphonates, corticosteroids, parathyroid hormone, RANKL inhibitors, past exposure to head and neck radiation, chemotherapy within the last 12 months, among others.
- Subjects with systemic diseases that impact bone metabolism and wound healing. Namely, osteoporosis, osteopenia, hyperparathyroidism, Paget's disease.
- Allergy to the graft materials.
- Pregnant subjects or individuals who self-report as attempting to become pregnant.
- Patient's unwilling to sign the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Alice Ou, RDH, MS, (734) 763-3346, aliceou@umich.edu
About this study
Official title: Phenotype Modification Via Guided Bone Regeneration and Acellular Dermal Matrix Simultaneous to Delayed Implant Placement: A Double Arm Randomized Controlled Clinical Trial.
Single implant sites with bone loss can often be managed by bone grafting alone. The purpose of this study is to determine whether putting a soft tissue graft substitute over the bone graft will provide an increased benefit for improving the health, appearance, and stability of the bone and gums surrounding the implant.
Read the detailed description
The study will treat patients that need a single implant at a previously edentulous site (>3 months post extraction) that requires phenotypic modification. These patients will receive an implant with simultaneous GBR, with half of the participants also receiving an ADM graft.
- Conditions
- Horizontal Ridge Deficiency
- Being tested
- Dental implant placement, Guided bone regeneration with collagen membrane, Guided bone regeneration with acellular dermal matrix.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placementProcedure or surgery
Participants will have a dental implant placed at a toothless site
Guided bone regeneration with collagen membraneProcedure or surgery
Participants will receive guided bone regeneration at a toothless site with bone substitute and a collagen membrane.
Guided bone regeneration with acellular dermal matrix.Procedure or surgery
Participants will receive guided bone regeneration at a toothless site with bone substitute and an acellular dermal matrix.
| Study group | Role | What they receive |
|---|---|---|
| Guided bone regeneration | Active comparator | Guided bone regeneration with collagen membrane Receives: Procedure: Dental implant placement; Procedure: Guided bone regeneration with collagen membrane |
| Guided bone regeneration with Phenotype modification. | Experimental | Guided bone regeneration with an allogenic dermal matrix Receives: Procedure: Dental implant placement; Procedure: Guided bone regeneration with acellular dermal matrix. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal linear change of the buccal bone
Radiographic changes of bone level in mm based on cone-beam computed tomography
Measured: 6 months
Secondary outcomes (6)
The volumetric changes of the facial soft tissue
Volumetric changes in mm^3 based on intraoral digital scans
Measured: 6 months
The vascular changes of the facial soft tissue
Vascular changes in mm^3 based on ultrasound scans
Measured: 6 months
Peri-implant health, as defined by clinical attachment level.
Changes in clinical attachment level measurements in mm
Measured: 6 months
Patient-reported morbidity, satisfaction and comfort using a visual analogue scale (VAS)
Difference in survey results
Measured: 6 months
Clinician-reported overall treatment effectiveness
Scale from 1 (Poor) to 5 (Excellent)
Measured: 6 months
Histological bone density
Histomorphometry
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 posted24 Jul 2025
- Study start1 Jun 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horizontal 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Saleh, University of Michigan
- Investigators
- Muhammad Saleh, BDS, MSD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082244
- Sponsor's protocol ID
- HUM00262601
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotype Modification Via Guided Bone Regeneration and Acellular Dermal Matrix Simultaneous to Delayed Implant Placement: A Double Arm Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07082244
- Acronym / sponsor ID
- HUM00262601
- Conditions
- Horizontal Ridge Deficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 24 Jul 2025 (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.
Single implant sites with bone loss can often be managed by bone grafting alone. The purpose of this study is to determine whether putting a soft tissue graft substitute over the bone graft will provide an increased benefit for improving the health, appearance, and stability of the bone and gums surrounding the implant.
Detailed description
The study will treat patients that need a single implant at a previously edentulous site (>3 months post extraction) that requires phenotypic modification. These patients will receive an implant with simultaneous GBR, with half of the participants also receiving an ADM graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided bone regeneration | Active comparator | Procedure: Dental implant placement, Procedure: Guided bone regeneration with collagen membraneGuided bone regeneration with collagen membrane |
| Guided bone regeneration with Phenotype modification. | Experimental | Procedure: Dental implant placement, Procedure: Guided bone regeneration with acellular dermal matrix.Guided bone regeneration with an allogenic dermal matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Subjects with a physical status of systemically healthy or suffering from mild to moderate, but well-controlled disease; American Society of Anesthesiology (ASA) I or II.
- Subjects must have one edentulous region, with at least 3 months of healing post-extraction, in the esthetic zone of the maxilla or the premolar and canine region of the mandible. This region includes the maxillary premolars, canines, and incisors.
- Subjects must have a full mouth plaque and bleeding score of less than or equal to 20%, measured at four sites per tooth.
- The patients should have a thin periodontal phenotype; bucco-lingual ridge thickness greater than 6mm.
Key exclusion criteria (7 listed)
- Presence of uncontrolled and/or untreated periodontal disease.
- Patients currently smoking cigarettes, cannabis, and electronic cigarettes.
- Subjects taking medications known to impact bone metabolism or have the capacity to affect wound healing. These drugs include bisphosphonates, corticosteroids, parathyroid hormone, RANKL inhibitors, past exposure to head and neck radiation, chemotherapy within the last 12 months, among others.
- Subjects with systemic diseases that impact bone metabolism and wound healing. Namely, osteoporosis, osteopenia, hyperparathyroidism, Paget's disease.
- Allergy to the graft materials.
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 |
|---|---|---|
| Dental implant placementParticipants will have a dental implant placed at a toothless site | Procedure or surgery | Guided bone regeneration, Guided bone regeneration with Phenotype modification. |
| Guided bone regeneration with collagen membraneParticipants will receive guided bone regeneration at a toothless site with bone substitute and a collagen membrane. | Procedure or surgery | Guided bone regeneration |
| Guided bone regeneration with acellular dermal matrix.Participants will receive guided bone regeneration at a toothless site with bone substitute and an acellular dermal matrix. | Procedure or surgery | Guided bone regeneration with Phenotype modification. |
Primary outcome
Horizontal linear change of the buccal bone
Time frame: 6 months
Radiographic changes of bone level in mm based on cone-beam computed tomography
6 secondary outcomes
The volumetric changes of the facial soft tissue
Time frame: 6 months
The vascular changes of the facial soft tissue
Time frame: 6 months
Peri-implant health, as defined by clinical attachment level.
Time frame: 6 months
Patient-reported morbidity, satisfaction and comfort using a visual analogue scale (VAS)
Time frame: 6 months
Clinician-reported overall treatment effectiveness
Time frame: 6 months
Histological bone density
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Horizontal Ridge Deficiency
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Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
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Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
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Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
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Shell Technique for Implant Site Development
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Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell
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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.
Muhammad Saleh, BDS, MSD principal investigator
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 Dental implant placement, Guided bone regeneration with collagen membrane and Guided bone regeneration with acellular dermal matrix. in people with 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Dunbar, DDS (734-763-3346, dgdunbar@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal linear change of the buccal bone (time frame: 6 months). 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 30 Jul 2026.