Alveolar Ridge DeficiencyPhase 4NCT06342973
Horizontal Ridge Augmentation With Demineralized Bone Allograft Layered With Xenograft - a Prospective Clinical Study
A Phase 4 study testing Xenograft and allograft in people with Alveolar Ridge Deficiency, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
The aim of this case series is to evaluate the outcomes of horizontal ridge augmentation performed using a combination of demineralized freeze-dried bone allograft layered with xenograft bone with a resorbable native collagen membrane. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Deficiency
- What is being tested?
- Xenograft and allograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2024to 15 Oct 2025
- Phase
- Phase 4
- 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
- Patients at least 18 years of age Patients requiring horizontal bone augmentation prior to implant placement ASA I or ASA II patients Non-smoker Patients willing to be followed up for a period of 6-9 months Patients must be physically able to tolerate conventional surgical procedure or procedures under IV moderate sedation.
Who cannot join
- Patients with uncontrolled diabetes Patients with history of radiation to the jaw Patient with immune compromise due to disease or medication Patients requiring primarily vertical bone augmentation prior to implant placement Patients taking bisphosphonates Patients with HIV or hepatitis infection Patients who are known to be pregnant or planning to within 6 months of study enrollment Patients with a history of a failed implant in the site. Patients with an active infection or pathology in the site of treatment that need to be treated prior to bone augmentation Patients with a history of untreated generalized chronic periodontitis Patients who are unable to provide consent and require a legally authorized representative to sign on their behalf
Trial locations and contacts
1 site in 1 country.
United States1 site
LSUHSC School of Dentistry
New Orleans, Louisiana, 70119
About this study
The aim of this case series is to evaluate the outcomes of horizontal ridge augmentation performed using a combination of demineralized freeze-dried bone allograft layered with xenograft bone with a resorbable native collagen membrane.
Read the detailed description
The aim of the study is to evaluate the outcomes of horizontal gone gain when demineralized freeze dried bone allograft (DFDBA) and xenograft are used in a layering technique.
Primary objectives are to compare the bone gain after the bone augmentation procedure. Secondary outcomes are to study the vital bone percentage formation after the bone augmentation procedure and to study the amount of shrinkage of the graft material observed after the procedure.
Test group will consist of patients receiving horizontal ridge augmentation using a combination of DFDBA layered with xenograft particulate bone using a resorbable collagen membrane. Surgical procedure is describe under assigned interventions.
Follow up and implant placement:
The patients will be followed up at 1-2, 3-5 and 6-8 weeks to assess the surgical site for healing. Following this, the patient will be allowed to heal for a period of 6-9 months at which point a cone beam computed tomography (CBCT) will be taken to evaluate the bone gain after horizontal ridge augmentation.
CBCT Measurements:
The images obtained from the CBCT scan will be transferred to a digital CBCT viewing software in which measurements will be carried out. The anatomical landmarks and adjacent teeth will be identified and used to orient the scan to get an image representing the buccal-palatal plane of the area of interest. The horizontal bone gain will be measured at 3,5,7 mm from the crest. Additionally, the amount of graft shrinkage will be measured between immediate post-operative CBCT and follow up CBCT.
Bone core biopsies:
Following at least 6 months of healing and follow up, patients will be appointed for implant placement. At this visit a full thickness flap will be raised. If anatomical considerations and space permits, a bone core biopsy will be obtained using a trephine and stored in formalin for histologic and histo-morphometric analysis. The harvesting of a bone core is considered additional for the study. It will only be performed if it is safe to do so and the harvesting of the core will not jeopardize the long-term longevity of the implant placement (not all patients that are part of the study will undergo the harvesting of a bone core). This bone core will be saved for histologic analysis.
Histologic preparation and evaluation:
Following the bone core removal, the biopsied specimens will be stored until further evaluation. The bone core biopsies will be prepared and evaluated at a lab. De-identified samples will be shipped to the lab for further analysis. Briefly, the biopsy will be dehydrated in a series of ethanol baths. Following this, it will be infiltrated in xylene and methyl metha-acrylate. Following embedding, the bone samples will be sectioned using a hard tissue microtome and stained with hematoxylin-eosin. The quantitative assessment of percentage vital bone, graft particles and connective tissue will be measured using a grid under magnification.
- Conditions
- Alveolar Ridge Deficiency
- Being tested
- Xenograft and allograft
- Keywords
- Horizontal ridge augmentation, Bone atrophy, Bone graft, Dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenograft and allograftDevice
For the guided bone augmentation procedure, a crestal incision with one or two vertical incision will be made and a full thickness mucoperiosteal flap will be elevated. Decortication will be performed and the patient will receive grafting with DFDBA with a buccal overlay of xenograft. A bi-layered native collagen membrane will be used and fixed with tacks or sutures. Periosteal incisions will be made to get tension free primary closure. The flap will be closed with sutures. Patients will be prescribed antibiotics, analgesics and mouth rinses as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Xenograft and allograft | Experimental | The group will consist of patients receiving horizontal ridge augmentation using a combination of Demineralized Freeze Dried Bone Allograft (DFDBA) layered with xenograft particulate bone using a resorbable collagen membrane. The DFDBA will be used internally in contact with the native bone and xenograft will be layered buccal to it. Receives: Device: Xenograft and allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of horizontal bone gain
Horizontal bone gain will be measured from post operative CBCT scans taken 6-9 months following the procedure
Measured: 6-9 months
Percentage of Vital bone
Vital bone percentage will be measured from the bone core trephines taken 6-9 months after the procedure during implant placement
Measured: 6-9 months
Amount of graft shrinkage
Graft shrinkage will be measured as the change in horizontal bone width between immediate post operative CBCT scans and scans taken at 6-9 months
Measured: 6-9 months
Secondary outcomes (1)
Incidence of surgical complications
Surgical complications will be noted during the healing period
Measured: 1-2 weeks, 3-5 weeks, 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start27 Mar 2024
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge DeficiencyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma
- Responsible party
- Sponsor
- Investigators
- Eswar Kandaswamy, MS, Principal investigator, LSUHSC School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342973
- Sponsor's protocol ID
- 5591
- Status last verified
- Jun 2025
- First submitted
- 27 Mar 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Horizontal Ridge Augmentation With Demineralized Bone Allograft Layered With Xenograft - a Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06342973
- Acronym / sponsor ID
- 5591
- Conditions
- Alveolar Ridge Deficiency
- Keywords
- Horizontal ridge augmentation, Bone atrophy, Bone graft, Dental implant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- Geistlich Pharma
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 2 Apr 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 aim of this case series is to evaluate the outcomes of horizontal ridge augmentation performed using a combination of demineralized freeze-dried bone allograft layered with xenograft bone with a resorbable native collagen membrane.
Detailed description
The aim of the study is to evaluate the outcomes of horizontal gone gain when demineralized freeze dried bone allograft (DFDBA) and xenograft are used in a layering technique.
Primary objectives are to compare the bone gain after the bone augmentation procedure. Secondary outcomes are to study the vital bone percentage formation after the bone augmentation procedure and to study the amount of shrinkage of the graft material observed after the procedure.
Test group will consist of patients receiving horizontal ridge augmentation using a combination of DFDBA layered with xenograft particulate bone using a resorbable collagen membrane. Surgical procedure is describe under assigned interventions.
Follow up and implant placement:
The patients will be followed up at 1-2, 3-5 and 6-8 weeks to assess the surgical site for healing. Following this, the patient will be allowed to heal for a period of 6-9 months at which point a cone beam computed tomography (CBCT) will be taken to evaluate the bone gain after horizontal ridge augmentation.
CBCT Measurements:
The images obtained from the CBCT scan will be transferred to a digital CBCT viewing software in which measurements will be carried out. The anatomical landmarks and adjacent teeth will be identified and used to orient the scan to get an image representing the buccal-palatal plane of the area of interest. The horizontal bone gain will be measured at 3,5,7 mm from the crest. Additionally, the amount of graft shrinkage will be measured between immediate post-operative CBCT and follow up CBCT.
Bone core biopsies:
Following at least 6 months of healing and follow up, patients will be appointed for implant placement. At this visit a full thickness flap will be raised. If anatomical considerations and space permits, a bone core biopsy will be obtained using a trephine and stored in formalin for histologic and histo-morphometric analysis. The harvesting of a bone core is considered additional for the study. It will only be performed if it is safe to do so and the harvesting of the core will not jeopardize the long-term longevity of the implant placement (not all patients that are part of the study will undergo the harvesting of a bone core). This bone core will be saved for histologic analysis.
Histologic preparation and evaluation:
Following the bone core removal, the biopsied specimens will be stored until further evaluation. The bone core biopsies will be prepared and evaluated at a lab. De-identified samples will be shipped to the lab for further analysis. Briefly, the biopsy will be dehydrated in a series of ethanol baths. Following this, it will be infiltrated in xylene and methyl metha-acrylate. Following embedding, the bone samples will be sectioned using a hard tissue microtome and stained with hematoxylin-eosin. The quantitative assessment of percentage vital bone, graft particles and connective tissue will be measured using a grid under magnification.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group
| Arm | Type | Receives |
|---|---|---|
| Xenograft and allograft | Experimental | Device: Xenograft and allograftThe group will consist of patients receiving horizontal ridge augmentation using a combination of Demineralized Freeze Dried Bone Allograft (DFDBA) layered with xenograft particulate bone using a resorbable collagen membrane. The DFDBA will be used internally in contact with the native bone and xenograft will be layered buccal to it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients at least 18 years of age Patients requiring horizontal bone augmentation prior to implant placement ASA I or ASA II patients Non-smoker Patients willing to be followed up for a period of 6-9 months Patients must be physically able to tolerate conventional surgical procedure or procedures under IV moderate sedation.
Key exclusion criteria (1 listed)
- Patients with uncontrolled diabetes Patients with history of radiation to the jaw Patient with immune compromise due to disease or medication Patients requiring primarily vertical bone augmentation prior to implant placement Patients taking bisphosphonates Patients with HIV or hepatitis infection Patients who are known to be pregnant or planning to within 6 months of study enrollment Patients with a history of a failed implant in the site. Patients with an active infection or pathology in the site of treatment that need to be treated prior to bone augmentation Patients with a history of untreated generalized chronic periodontitis Patients who are unable to provide consent and require a legally authorized representative to sign on their behalf
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 |
|---|---|---|
| Xenograft and allograftFor the guided bone augmentation procedure, a crestal incision with one or two vertical incision will be made and a full thickness mucoperiosteal flap will be elevated. Decortication will be performed and the patient will receive grafting with DFDBA with a buccal overlay of xenograft. A bi-layered native collagen membrane will be used and fixed with tacks or sutures. Periosteal incisions will be made to get tension free primary closure. The flap will be closed with sutures. Patients will be prescribed antibiotics, analgesics and mouth rinses as appropriate. | Device | Xenograft and allograft |
Primary outcome
Amount of horizontal bone gain
Time frame: 6-9 months
Horizontal bone gain will be measured from post operative CBCT scans taken 6-9 months following the procedure
Percentage of Vital bone
Time frame: 6-9 months
Vital bone percentage will be measured from the bone core trephines taken 6-9 months after the procedure during implant placement
Amount of graft shrinkage
Time frame: 6-9 months
Graft shrinkage will be measured as the change in horizontal bone width between immediate post operative CBCT scans and scans taken at 6-9 months
1 secondary outcome
Incidence of surgical complications
Time frame: 1-2 weeks, 3-5 weeks, 6-8 weeks
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 21 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Alveolar Ridge Deficiency
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
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Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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Shell Technique for Implant Site Development
Ridge Augmentation, Ridge Deficiency
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Effectiveness of Subepithelial Connective Tissue Graft as an Autogenous Barrier Membrane for Hard and Soft Tissue Augmentation in Horizontally Deficient Ridges During Delayed Implant Placement
Horizontally Deficient Alveolar Ridges, Hard and Soft Tissue Augmentation During Delayed Implant Placement
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.
Eswar Kandaswamy, MS principal investigator
LSUHSC School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xenograft and allograft in people with Alveolar Ridge Deficiency, run by Louisiana State University Health Sciences Center in New Orleans 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 1 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 21 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Amount of horizontal bone gain (time frame: 6-9 months). The study lists 3 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 21 Nov 2025.