Alveolar Bone LossNCT07572643
Lamina Soft With Different Collagen Based Materials in Bone Regeneration
A study testing Guided Bone Regeneration with Implant Placement, Collagenated Xenogeneic Bone Graft and Hydroxyapatite Xenograft with Autologous Bone in people with Alveolar Bone Loss, run by Nicola Alberto Valente, DDS, MS, PhD at 1 site in Italy.
Trial summary
This prospective controlled clinical pilot study will compare the effectiveness of two different grafting strategies for horizontal bone regeneration in healed post-extraction sites with buccal bone deficiency, using a collagenated porcine cortical bone lamina as a barrier membrane. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Guided Bone Regeneration with Implant Placement, Collagenated Xenogeneic Bone Graft and Hydroxyapatite Xenograft with Autologous Bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to 30 Jan 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healed type II post-extraction sockets according to the Elian classification
- Age between 18 and 80 years
- Good periodontal control, defined as treated periodontitis with plaque index <25% and bleeding on probing <25%
- ASA I or ASA II systemic status
- Ability and willingness to provide written informed consent
- Ability and willingness to attend scheduled follow-up visits
Who cannot join
- Smoking more than 10 cigarettes per day
- Active oral infections
- Mucosal diseases, including erosive lichen planus
- History of radiotherapy in the head and neck region
- Systemic diseases affecting bone metabolism or contraindicating oral surgery
- Non-compliance or inability to complete follow-up
- Extraction sockets with intact bone walls
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of OsteoBiol® Lamina® Soft and Different Collagen-based Graft Materials in Bone Regeneration: A Pilot Prospective Controlled Clinical Trial
This prospective controlled clinical pilot study will compare the effectiveness of two different grafting strategies for horizontal bone regeneration in healed post-extraction sites with buccal bone deficiency, using a collagenated porcine cortical bone lamina as a barrier membrane.
A total of 21 patients requiring implant-supported rehabilitation associated with bone regeneration will be enrolled, for a total of 40 implants. In the test group, bone defects will be grafted using a collagenated cortico-cancellous sticky xenograft, while in the control group a mixture of hydroxyapatite-based xenograft and autologous bone in a 1:1 ratio will be used. In both groups, a semi-rigid collagenated cortical bone lamina will be applied and stabilized to contain the graft material and maintain space for regeneration.
Read more
The primary objective of the study will be to evaluate volumetric bone changes over time using cone-beam computed tomography imaging, comparing baseline and follow-up scans. Secondary outcomes will include linear measurements of bone gain at different levels around the implant site.
The study will investigate whether collagenated xenografts alone can provide comparable clinical and radiographic outcomes to combined grafting approaches including autologous bone, while potentially reducing patient morbidity associated with bone harvesting.
Read the detailed description
Severe alveolar ridge resorption following tooth extraction may result in insufficient bone width and compromised anatomical conditions for implant placement, particularly in sites with buccal cortical plate deficiency. In such cases, guided bone regeneration (GBR) procedures will be required to restore adequate bone volume and allow for prosthetically driven implant rehabilitation.
A wide range of grafting materials will be used in clinical practice for bone regeneration, including autologous bone, allogeneic and xenogeneic biomaterials, as well as synthetic substitutes. Among these, xenogeneic collagenated grafts will be increasingly adopted due to their favorable biological properties, including clot stabilization, facilitation of early cellular infiltration, and promotion of angiogenesis. However, their relatively rapid remodeling rate may influence the final volumetric stability of the regenerated bone.
Barrier membranes will play a crucial role in GBR procedures by preventing soft tissue invasion and maintaining space for bone regeneration. Recently, collagenated porcine cortical bone laminae will be introduced as semi-rigid membranes combining the advantages of mechanical stability and biocompatibility. When properly stabilized, these devices will act as containment structures for graft materials, potentially improving regenerative outcomes.
The present study will be designed as a prospective controlled clinical trial to evaluate the effectiveness of two different grafting strategies for horizontal bone regeneration in healed post-extraction sites presenting buccal bone deficiency. Patients requiring implant-supported rehabilitation associated with bone augmentation procedures will be consecutively enrolled and allocated to one of two treatment groups.
In the test group, bone defects will be grafted using a collagenated cortico-cancellous sticky xenograft. In the control group, a mixture of hydroxyapatite-based xenograft and autologous bone in a 1:1 ratio will be used. In both groups, a collagenated porcine cortical bone lamina will be applied as a barrier membrane and stabilized using fixation pins to ensure space maintenance and graft containment.
All surgical procedures will be performed under local anesthesia by an experienced operator following standardized clinical protocols. After implant placement and grafting, primary wound closure will be achieved, and patients will receive appropriate postoperative care, including antibiotics and analgesics as indicated. Sutures will be removed after a healing period of approximately 10-14 days.
Radiographic evaluation will be performed using cone-beam computed tomography (CBCT) scans acquired before surgery (baseline) and at follow-up. Digital datasets will be analyzed using dedicated three-dimensional software to assess volumetric changes in the regenerated bone. Linear measurements will also be obtained at predefined reference levels around the implant site, including the implant neck, 3 mm apically, and at the implant apex.
Implant-supported prosthetic rehabilitation will be completed after a healing period of approximately six months, following confirmation of implant osseointegration.
The primary outcome of the study will be the volumetric change of regenerated bone over time. Secondary outcomes will include linear bone gain at different levels and the influence of clinical and anatomical variables such as patient age, sex, and implant site localization.
Statistical analysis will be performed at the implant level. Continuous variables will be assessed for normality and compared between groups using appropriate parametric or non-parametric tests. Multivariable regression models will be applied to evaluate the association between treatment group and outcomes while adjusting for potential confounding variables.
This study will aim to determine whether collagenated xenografts alone will provide comparable regenerative outcomes to combined approaches including autologous bone, potentially reducing surgical invasiveness and donor-site morbidity while maintaining adequate bone volume for implant-supported rehabilitation.
- Conditions
- Alveolar Bone Loss
- Being tested
- Guided Bone Regeneration with Implant Placement, Collagenated Xenogeneic Bone Graft, Hydroxyapatite Xenograft with Autologous Bone
- Keywords
- Guided Bone Regeneration, Collagenated Xenograft, Autologous Bone, Post-Extraction Socket, Cortical Bone Lamina, Implant Rehabilitation
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Bone Regeneration with Implant PlacementProcedure or surgery
Participants will undergo implant placement combined with guided bone regeneration in healed post-extraction sites with buccal bone deficiency. The surgical procedure will include defect debridement, graft placement, and stabilization using a collagenated porcine cortical bone lamina as a semi-rigid barrier membrane fixed with pins. Primary closure will be achieved, and postoperative care will follow standard clinical protocols.
Collagenated Xenogeneic Bone GraftProcedure or surgery
A collagenated cortico-cancellous xenogeneic bone graft material will be used to fill the bone defect during guided bone regeneration procedures. The material will be applied to promote early vascularization and cellular infiltration, supporting bone regeneration while undergoing physiological remodeling over time.
Hydroxyapatite Xenograft with Autologous BoneProcedure or surgery
A mixture of hydroxyapatite-based xenogeneic bone graft and autologous bone in a 1:1 ratio will be used to fill the bone defect during guided bone regeneration procedures. The autologous component will provide osteogenic and osteoinductive potential, while the xenograft will contribute to long-term volume stability.
| Study group | Role | What they receive |
|---|---|---|
| Collagenated Xenograft + Cortical Lamina | Experimental | Participants in this arm will undergo horizontal bone regeneration using a collagenated cortico-cancellous xenogeneic graft material. The graft will be placed in healed post-extraction sites presenting buccal bone deficiency. A collagenated porcine cortical bone lamina will be used as a semi-rigid barrier membrane and stabilized with fixation pins to contain the graft and maintain space for bone regeneration. Implant placement will be performed in conjunction with the regenerative procedure. Receives: Procedure: Guided Bone Regeneration with Implant Placement; Procedure: Collagenated Xenogeneic Bone Graft |
| Hydroxyapatite Xenograft + Autologous Bone + Cortical Lamina | Active comparator | Participants in this arm will undergo horizontal bone regeneration using a mixture of hydroxyapatite-based xenogeneic graft material and autologous bone in a 1:1 ratio. The graft will be placed in healed post-extraction sites with buccal bone deficiency. A collagenated porcine cortical bone lamina will be used as a semi-rigid barrier membrane and stabilized with fixation pins to ensure graft containment and space maintenance. Implant placement will be performed in conjunction with the regenerative procedure. Receives: Procedure: Guided Bone Regeneration with Implant Placement; Procedure: Hydroxyapatite Xenograft with Autologous Bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric Bone Change
Change in regenerated bone volume will be assessed using cone-beam computed tomography scans acquired at baseline and follow-up. DICOM datasets will be superimposed and analyzed with dedicated three-dimensional software. Regenerated bone volume will be expressed in cubic millimeters.
Measured: Baseline to 24-36 months after surgery
Secondary outcomes (3)
Linear Bone Gain at Implant Neck
Horizontal linear bone gain will be measured on cone-beam computed tomography scans at the implant neck level.
Measured: Baseline to 24-36 months after surgery
Linear Bone Gain 3 mm Apical to Implant Neck
Horizontal linear bone gain will be measured on cone-beam computed tomography scans at 3 mm apical to the implant neck.
Measured: Baseline to 24-36 months after surgery
Linear Bone Gain at Implant Apex
Horizontal linear bone gain will be measured on cone-beam computed tomography scans at the implant apex level.
Measured: Baseline to 24-36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Jul 2022
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated to one of two parallel groups based on the chronological order of enrollment. The test group will receive bone regeneration using a collagenated cortico-cancellous sticky xenograft, while the control group will receive a mixture of hydroxyapatite-based xenograft and autologous bone in a 1:1 ratio. In both groups, a collagenated porcine cortical bone lamina will be used as a barrier membrane. The study will compare radiographic and clinical outcomes between the two groups.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicola Alberto Valente, DDS, MS, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Link Campus University, Universita degli Studi di Genova, Saint Camillus International University of Health Sciences
- Responsible party
- Sponsor-investigator, Nicola Alberto Valente, DDS, MS, PhD, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572643
- Sponsor's protocol ID
- Lamina
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request to the corresponding author, following publication of the study results. Data sharing will be subject to institutional policies and applicable regulations to ensure patient confidentiality and data protection.
Publications
Couso-Queiruga E, Weber HA, Garaicoa-Pazmino C, Barwacz C, Kalleme M, Galindo-Moreno P, Avila-Ortiz G. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: A randomized clinical trial. J Clin Periodontol. 2023 Feb;50(2):132-146. doi: 10.1111/jcpe.13744. Epub 2022 Nov 18.
PubMed 36345818Barone A, Toti P, Menchini-Fabris GB, Derchi G, Marconcini S, Covani U. Extra oral digital scanning and imaging superimposition for volume analysis of bone remodeling after tooth extraction with and without 2 types of particulate porcine mineral insertion: A randomized controlled trial. Clin Implant Dent Relat Res. 2017 Aug;19(4):750-759. doi: 10.1111/cid.12495. Epub 2017 May 16.
PubMed 28508515Calciolari E, Corbella S, Gkranias N, Vigano M, Sculean A, Donos N. Efficacy of biomaterials for lateral bone augmentation performed with guided bone regeneration. A network meta-analysis. Periodontol 2000. 2023 Oct;93(1):77-106. doi: 10.1111/prd.12531. Epub 2023 Sep 27.
PubMed 37752820Susin C, Wikesjo UM. Regenerative periodontal therapy: 30 years of lessons learned and unlearned. Periodontol 2000. 2013 Jun;62(1):232-42. doi: 10.1111/prd.12003.
PubMed 23574469
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of OsteoBiol® Lamina® Soft and Different Collagen-based Graft Materials in Bone Regeneration: A Pilot Prospective Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07572643
- Acronym / sponsor ID
- Lamina
- Conditions
- Alveolar Bone Loss
- Keywords
- Guided Bone Regeneration, Collagenated Xenograft, Autologous Bone, Post-Extraction Socket, Cortical Bone Lamina, Implant Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nicola Alberto Valente, DDS, MS, PhDUniversity, hospital or other
- Collaborators
- Link Campus University, Universita degli Studi di Genova, Saint Camillus International University of Health Sciences
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 7 May 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.
This prospective controlled clinical pilot study will compare the effectiveness of two different grafting strategies for horizontal bone regeneration in healed post-extraction sites with buccal bone deficiency, using a collagenated porcine cortical bone lamina as a barrier membrane.
A total of 21 patients requiring implant-supported rehabilitation associated with bone regeneration will be enrolled, for a total of 40 implants. In the test group, bone defects will be grafted using a collagenated cortico-cancellous sticky xenograft, while in the control group a mixture of hydroxyapatite-based xenograft and autologous bone in a 1:1 ratio will be used. In both groups, a semi-rigid collagenated cortical bone lamina will be applied and stabilized to contain the graft material and maintain space for regeneration.
The primary objective of the study will be to evaluate volumetric bone changes over time using cone-beam computed tomography imaging, comparing baseline and follow-up scans. Secondary outcomes will include linear measurements of bone gain at different levels around the implant site.
The study will investigate whether collagenated xenografts alone can provide comparable clinical and radiographic outcomes to combined grafting approaches including autologous bone, while potentially reducing patient morbidity associated with bone harvesting.
Detailed description
Severe alveolar ridge resorption following tooth extraction may result in insufficient bone width and compromised anatomical conditions for implant placement, particularly in sites with buccal cortical plate deficiency. In such cases, guided bone regeneration (GBR) procedures will be required to restore adequate bone volume and allow for prosthetically driven implant rehabilitation.
A wide range of grafting materials will be used in clinical practice for bone regeneration, including autologous bone, allogeneic and xenogeneic biomaterials, as well as synthetic substitutes. Among these, xenogeneic collagenated grafts will be increasingly adopted due to their favorable biological properties, including clot stabilization, facilitation of early cellular infiltration, and promotion of angiogenesis. However, their relatively rapid remodeling rate may influence the final volumetric stability of the regenerated bone.
Barrier membranes will play a crucial role in GBR procedures by preventing soft tissue invasion and maintaining space for bone regeneration. Recently, collagenated porcine cortical bone laminae will be introduced as semi-rigid membranes combining the advantages of mechanical stability and biocompatibility. When properly stabilized, these devices will act as containment structures for graft materials, potentially improving regenerative outcomes.
The present study will be designed as a prospective controlled clinical trial to evaluate the effectiveness of two different grafting strategies for horizontal bone regeneration in healed post-extraction sites presenting buccal bone deficiency. Patients requiring implant-supported rehabilitation associated with bone augmentation procedures will be consecutively enrolled and allocated to one of two treatment groups.
In the test group, bone defects will be grafted using a collagenated cortico-cancellous sticky xenograft. In the control group, a mixture of hydroxyapatite-based xenograft and autologous bone in a 1:1 ratio will be used. In both groups, a collagenated porcine cortical bone lamina will be applied as a barrier membrane and stabilized using fixation pins to ensure space maintenance and graft containment.
All surgical procedures will be performed under local anesthesia by an experienced operator following standardized clinical protocols. After implant placement and grafting, primary wound closure will be achieved, and patients will receive appropriate postoperative care, including antibiotics and analgesics as indicated. Sutures will be removed after a healing period of approximately 10-14 days.
Radiographic evaluation will be performed using cone-beam computed tomography (CBCT) scans acquired before surgery (baseline) and at follow-up. Digital datasets will be analyzed using dedicated three-dimensional software to assess volumetric changes in the regenerated bone. Linear measurements will also be obtained at predefined reference levels around the implant site, including the implant neck, 3 mm apically, and at the implant apex.
Implant-supported prosthetic rehabilitation will be completed after a healing period of approximately six months, following confirmation of implant osseointegration.
The primary outcome of the study will be the volumetric change of regenerated bone over time. Secondary outcomes will include linear bone gain at different levels and the influence of clinical and anatomical variables such as patient age, sex, and implant site localization.
Statistical analysis will be performed at the implant level. Continuous variables will be assessed for normality and compared between groups using appropriate parametric or non-parametric tests. Multivariable regression models will be applied to evaluate the association between treatment group and outcomes while adjusting for potential confounding variables.
This study will aim to determine whether collagenated xenografts alone will provide comparable regenerative outcomes to combined approaches including autologous bone, potentially reducing surgical invasiveness and donor-site morbidity while maintaining adequate bone volume for implant-supported rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be allocated to one of two parallel groups based on the chronological order of enrollment. The test group will receive bone regeneration using a collagenated cortico-cancellous sticky xenograft, while the control group will receive a mixture of hydroxyapatite-based xenograft and autologous bone in a 1:1 ratio. In both groups, a collagenated porcine cortical bone lamina will be used as a barrier membrane. The study will compare radiographic and clinical outcomes between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Collagenated Xenograft + Cortical Lamina | Experimental | Procedure: Guided Bone Regeneration with Implant Placement, Procedure: Collagenated Xenogeneic Bone GraftParticipants in this arm will undergo horizontal bone regeneration using a collagenated cortico-cancellous xenogeneic graft material. The graft will be placed in healed post-extraction sites presenting buccal bone deficiency. A collagenated porcine cortical bone lamina will be used as a semi-rigid barrier membrane and stabilized with fixation pins to contain the graft and maintain space for bone regeneration. Implant placement will be performed in conjunction with the regenerative procedure. |
| Hydroxyapatite Xenograft + Autologous Bone + Cortical Lamina | Active comparator | Procedure: Guided Bone Regeneration with Implant Placement, Procedure: Hydroxyapatite Xenograft with Autologous BoneParticipants in this arm will undergo horizontal bone regeneration using a mixture of hydroxyapatite-based xenogeneic graft material and autologous bone in a 1:1 ratio. The graft will be placed in healed post-extraction sites with buccal bone deficiency. A collagenated porcine cortical bone lamina will be used as a semi-rigid barrier membrane and stabilized with fixation pins to ensure graft containment and space maintenance. Implant placement will be performed in conjunction with the regenerative procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healed type II post-extraction sockets according to the Elian classification
- Age between 18 and 80 years
- Good periodontal control, defined as treated periodontitis with plaque index <25% and bleeding on probing <25%
- ASA I or ASA II systemic status
- Ability and willingness to provide written informed consent
Key exclusion criteria (7 listed)
- Smoking more than 10 cigarettes per day
- Active oral infections
- Mucosal diseases, including erosive lichen planus
- History of radiotherapy in the head and neck region
- Systemic diseases affecting bone metabolism or contraindicating oral surgery
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 with Implant PlacementParticipants will undergo implant placement combined with guided bone regeneration in healed post-extraction sites with buccal bone deficiency. The surgical procedure will include defect debridement, graft placement, and stabilization using a collagenated porcine cortical bone lamina as a semi-rigid barrier membrane fixed with pins. Primary closure will be achieved, and postoperative care will follow standard clinical protocols. | Procedure or surgery | Collagenated Xenograft + Cortical Lamina, Hydroxyapatite Xenograft + Autologous Bone + Cortical Lamina |
| Collagenated Xenogeneic Bone GraftA collagenated cortico-cancellous xenogeneic bone graft material will be used to fill the bone defect during guided bone regeneration procedures. The material will be applied to promote early vascularization and cellular infiltration, supporting bone regeneration while undergoing physiological remodeling over time. | Procedure or surgery | Collagenated Xenograft + Cortical Lamina |
| Hydroxyapatite Xenograft with Autologous BoneA mixture of hydroxyapatite-based xenogeneic bone graft and autologous bone in a 1:1 ratio will be used to fill the bone defect during guided bone regeneration procedures. The autologous component will provide osteogenic and osteoinductive potential, while the xenograft will contribute to long-term volume stability. | Procedure or surgery | Hydroxyapatite Xenograft + Autologous Bone + Cortical Lamina |
Primary outcome
Volumetric Bone Change
Time frame: Baseline to 24-36 months after surgery
Change in regenerated bone volume will be assessed using cone-beam computed tomography scans acquired at baseline and follow-up. DICOM datasets will be superimposed and analyzed with dedicated three-dimensional software. Regenerated bone volume will be expressed in cubic millimeters.
3 secondary outcomes
Linear Bone Gain at Implant Neck
Time frame: Baseline to 24-36 months after surgery
Linear Bone Gain 3 mm Apical to Implant Neck
Time frame: Baseline to 24-36 months after surgery
Linear Bone Gain at Implant Apex
Time frame: Baseline to 24-36 months after surgery
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 7 May 2026.
- Background: PubMed 36345818Couso-Queiruga E, Weber HA, Garaicoa-Pazmino C, Barwacz C, Kalleme M, Galindo-Moreno P, Avila-Ortiz G. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: A randomized clinical trial. J Clin Periodontol. 2023 Feb;50(2):132-146. doi: 10.1111/jcpe.13744. Epub 2022 Nov 18.
- Background: PubMed 28508515Barone A, Toti P, Menchini-Fabris GB, Derchi G, Marconcini S, Covani U. Extra oral digital scanning and imaging superimposition for volume analysis of bone remodeling after tooth extraction with and without 2 types of particulate porcine mineral insertion: A randomized controlled trial. Clin Implant Dent Relat Res. 2017 Aug;19(4):750-759. doi: 10.1111/cid.12495. Epub 2017 May 16.
- Background: PubMed 37752820Calciolari E, Corbella S, Gkranias N, Vigano M, Sculean A, Donos N. Efficacy of biomaterials for lateral bone augmentation performed with guided bone regeneration. A network meta-analysis. Periodontol 2000. 2023 Oct;93(1):77-106. doi: 10.1111/prd.12531. Epub 2023 Sep 27.
- Background: PubMed 23574469Susin C, Wikesjo UM. Regenerative periodontal therapy: 30 years of lessons learned and unlearned. Periodontol 2000. 2013 Jun;62(1):232-42. doi: 10.1111/prd.12003.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request to the corresponding author, following publication of the study results. Data sharing will be subject to institutional policies and applicable regulations to ensure patient confidentiality and data protection.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 with Implant Placement, Collagenated Xenogeneic Bone Graft and Hydroxyapatite Xenograft with Autologous Bone in people with Alveolar Bone Loss, run by Nicola Alberto Valente, DDS, MS, PhD at 1 site in Italy.
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 6 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: finished, as of the sponsor's last update on 7 May 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 Italy. 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?
Volumetric Bone Change (time frame: Baseline to 24-36 months after surgery). 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 NCT07572643, which also lists 4 linked publications.
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 7 May 2026.