Horizontal Ridge DeficiencyNCT05013580
The "Open Wound Bone Augmentation Concept" with Amnion-Chorion Membrane
A study testing Guided bone regeneration (GBR) in people with Horizontal Ridge Deficiency, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to compare two bone graft wound healing techniques; an open wound healing approach versus the standard closed wound healing approach. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2021to 4 May 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at least 21 years of age
- Be missing 1 to 2 back teeth in the lower jaw for at least three months
- Need horizontal bone ridge augmentation (gain width of the bone) prior to implant placement, determined clinically and radiographically
- Have enough bone height at the site
Who cannot join
- Currently smoke more than 10 cigarettes a day (self-reported)
- Have any medical conditions or jaw pathology that we decide might influence the outcome of the study
- Are pregnant or are lactating (self-reported)
- Have unstable periodontal disease or other dental infection
- Have poor oral hygiene
- Have any clinical conditions that make the subject unsuitable for bone graft 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: The "Open Wound Bone Augmentation Concept" with Amnion-Chorion Membrane: a Randomized Controlled Trial
The purpose of this study is to compare two bone graft wound healing techniques; an open wound healing approach versus the standard closed wound healing approach.
Read the detailed description
Open wound healing approach (experimental technique): the wound where the graft was attached to the bone will be filled with a type of tissue (the amnion-chorion membrane) taken from a placenta (the tissue sac that surrounds an embryo) and will be left partially open to heal.
Closed wound healing approach (standard technique): the wound where the graft was attached to the bone will be filled with collagen tissue (processed bone grafts from donors) and stitched closed while it heals.
20 patients needing more bone before placing a dental implant will be recruited for this trial. Patients will be randomized to either the test (open wound healing approach) or control (closed wound healing approach) group.
- Conditions
- Horizontal Ridge Deficiency
- 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
Also called Horizontal bone augmentation (HBA)
Bone grafts will be placed in the patient's jawbone, along with a membrane to cover the bone grafts. A horizontal incision over the edentulous ridge crest will be made along with vertical incisions if indicated. Buccal and lingual full thickness mucoperiosteal flaps will be reflected to expose the alveolar bone. Intra-marrow penetration (decortication of the alveolar bone to increase vascular supply to the bone grafts) at the surgical site alveolar bone will be made with a high-speed hand piece and diamond bur. Bone allograft material will be placed to fill the alveolar bone defect. The bone graft will then be covered with a membrane and secured with sutures.
| Study group | Role | What they receive |
|---|---|---|
| Open Wound | Experimental | After horizontal bone grafting, the wound where the graft was attached to the bone will be filled with a type of tissue (the amnion-chorion membrane) taken from a placenta and will be left partially open to heal. Receives: Procedure: Guided bone regeneration (GBR) |
| Closed Wound | Active comparator | After horizontal bone grafting, the wound where the graft was attached to the bone will be filled with collagen tissue and stitched closed while it heals. 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
Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements
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 posted19 Aug 2021
- Study start8 Oct 2021
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 20 participants (actual)
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
- NCT05013580
- Sponsor's protocol ID
- HUM00161016
- Status last verified
- Sep 2023
- First submitted
- 16 Aug 2021
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez Betancourt A, Yu SH, Ramos JM, Masotti M, Zambrana N, Kripfgans O, Chan HL. Correlations between early ultrasound markers and the outcomes of staged lateral guided bone regeneration. J Periodontal Implant Sci. 2026 Jun;56(3):224-237. doi: 10.5051/jpis.2403380169. Epub 2026 Feb 3.
PubMed 41968711
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "Open Wound Bone Augmentation Concept" with Amnion-Chorion Membrane: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05013580
- Acronym / sponsor ID
- HUM00161016
- Conditions
- Horizontal Ridge Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 19 Aug 2021 (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 two bone graft wound healing techniques; an open wound healing approach versus the standard closed wound healing approach.
Detailed description
Open wound healing approach (experimental technique): the wound where the graft was attached to the bone will be filled with a type of tissue (the amnion-chorion membrane) taken from a placenta (the tissue sac that surrounds an embryo) and will be left partially open to heal.
Closed wound healing approach (standard technique): the wound where the graft was attached to the bone will be filled with collagen tissue (processed bone grafts from donors) and stitched closed while it heals.
20 patients needing more bone before placing a dental implant will be recruited for this trial. Patients will be randomized to either the test (open wound healing approach) or control (closed wound healing approach) group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Wound | Experimental | Procedure: Guided bone regeneration (GBR)After horizontal bone grafting, the wound where the graft was attached to the bone will be filled with a type of tissue (the amnion-chorion membrane) taken from a placenta and will be left partially open to heal. |
| Closed Wound | Active comparator | Procedure: Guided bone regeneration (GBR)After horizontal bone grafting, the wound where the graft was attached to the bone will be filled with collagen tissue and stitched closed while it heals. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 21 years of age
- Be missing 1 to 2 back teeth in the lower jaw for at least three months
- Need horizontal bone ridge augmentation (gain width of the bone) prior to implant placement, determined clinically and radiographically
- Have enough bone height at the site
Key exclusion criteria (6 listed)
- Currently smoke more than 10 cigarettes a day (self-reported)
- Have any medical conditions or jaw pathology that we decide might influence the outcome of the study
- Are pregnant or are lactating (self-reported)
- Have unstable periodontal disease or other dental infection
- Have poor oral hygiene
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)Also: Horizontal bone augmentation (HBA)Bone grafts will be placed in the patient's jawbone, along with a membrane to cover the bone grafts. A horizontal incision over the edentulous ridge crest will be made along with vertical incisions if indicated. Buccal and lingual full thickness mucoperiosteal flaps will be reflected to expose the alveolar bone. Intra-marrow penetration (decortication of the alveolar bone to increase vascular supply to the bone grafts) at the surgical site alveolar bone will be made with a high-speed hand piece and diamond bur. Bone allograft material will be placed to fill the alveolar bone defect. The bone graft will then be covered with a membrane and secured with sutures. | Procedure or surgery | Closed Wound, Open Wound |
Primary outcome
Ridge width changes
Time frame: 6 months
Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements
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 25 Sep 2024.
- Derived from this study: PubMed 41968711Rodriguez Betancourt A, Yu SH, Ramos JM, Masotti M, Zambrana N, Kripfgans O, Chan HL. Correlations between early ultrasound markers and the outcomes of staged lateral guided bone regeneration. J Periodontal Implant Sci. 2026 Jun;56(3):224-237. doi: 10.5051/jpis.2403380169. Epub 2026 Feb 3.
- Individual participant dataSharing planned: No
Related trials for Horizontal Ridge Deficiency
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Shell Technique for Implant Site Development
Ridge Augmentation, Ridge Deficiency
Recruiting
Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell
Alveolar Bone Loss, Alveolar Ridge Deficiency
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.
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 Guided bone regeneration (GBR) 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 4 inclusion and 6 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 25 Sep 2024. 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?
Ridge width changes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05013580, which also lists 1 linked publication.
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 Sep 2024.