Guided Bone RegenerationPhase 4NCT07525128
Lateral GBR Using Two Types of Membrane With a Combination of Allograft-xenograft
A Phase 4 study testing Lateral Guided bone regeneration in people with Guided Bone Regeneration and Bone Augmentation, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
Bone width is critical for successful implant placement, as thin bone increases the risk of bone loss. Various augmentation techniques-especially guided bone regeneration (GBR)-are effective in restoring bone volume using grafts and barrier membranes. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Guided Bone Regeneration, Bone Augmentation
- What is being tested?
- Lateral Guided bone regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteLebanon
- Study dates
- 10 Mar 2025to 15 Apr 2026
- Phase
- Phase 4
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - Patients aged 20 to 75 years.
- Healthy individuals, either non-smokers or smokers consuming fewer than 10 cigarettes per day.
- Full mouth bleeding score (FmBS) below 20%.
- Full mouth plaque score (FmPS) below 15%.
- Presence of a residual alveolar ridge with a bone width of less than 6 mm but sufficient bone height in the maxilla or mandible.
- Tooth extraction must have been performed at least six weeks prior to surgery.
- Adequate number of teeth to allow for the use of an occlusal stent or radiographic guide.
Who cannot join
- - Presence of systemic illnesses.
- Smoking more than 10 cigarettes per day.
- Underwent radiotherapy in the head or neck region within the past 5 years.
- Active periodontitis affecting the remaining teeth.
- Pregnancy.
- Use of medications that could impact bone turnover or mucosal healing, such as tetracycline in the last month, steroids within the past 6 months, bisphosphonates, therapeutic doses of fluorides, or vitamin D and its metabolites within the last 6 months.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site
Saint Joseph University of Beirut , Campus of Medical Sciences
Beirut, Beirut, 10001111
About this study
Official title: Lateral Ridge Augmentation Using Cross-linked or Peritoneum Collagen Membrane With a Composite Allograft-xenograft Mix: a Randomized Clinical Trial
Bone width is critical for successful implant placement, as thin bone increases the risk of bone loss. Various augmentation techniques-especially guided bone regeneration (GBR)-are effective in restoring bone volume using grafts and barrier membranes. Collagen membranes are commonly used but degrade quickly, leading to the development of improved types like porcine peritoneum membranes, which show better strength and durability. While autogenous grafts are the gold standard, combining different graft materials (e.g., xenograft and allograft) has shown promising results. However, no studies have directly compared porcine peritoneum membranes with cross-linked membranes using such graft combinations. This study aims to evaluate and compare their effectiveness in increasing bone width.
Read the detailed description
Bone width is of major importance for implant placement, particularly in ensuring the long-term success and stability of the implant. Implants placed in the presence of thin buccal bone width are significantly more prone to exhibit major dimensional changes and vestibular bone loss (1,2). Various lateral bone augmentation techniques, such as guided bone regeneration, ridge expansion, distraction osteogenesis, and block grafting, have consistently demonstrated efficacy in restoring alveolar ridge dimensions(3). Additionally, the application of different types of graft materials-autogenous, xenogeneic, and allogenic-has been extensively documented in the literature for use in the lateral approach, further enhancing the success of these procedures(4).
Guided bone regeneration (GBR) has become a widely accepted and studied clinical method for the management of horizontal ridge deficiency . It is a biological technique designed to facilitate bone regeneration by creating a space that employs bone grafts and barrier membranes during the surgical procedure(5). Various types of barrier membranes are available for GBR, broadly categorized into non-resorbable and resorbable types. Non-resorbable membranes, like those made from polytetrafluoroethylene (PTFE), require a second surgical procedure for removal, while resorbable membranes, such as collagen-based membranes, can be left in place as they are integrated and eventually absorbed by the body(6). Among the various materials tested for use as regenerative tissue barriers, collagen has emerged as an optimal choice, meeting many necessary criteria(7,8). However, a significant limitation is the challenge of sustaining its barrier function for an adequate duration, typically lasting only four weeks due to the rapid biodegradation caused by the enzymatic activity of host tissues and microorganisms. To address this issue, various physical, chemical, and enzymatic cross-linking methods have been developed to prolong the degradation rate of collagen membranes. Consequently, there is a broad array of collagen types available, each differing based on its extraction source, offering versatility for various clinical applications(9). A recent advancement in collagen membranes is the introduction of the porcine peritoneum collagen membrane, a natural, non-cross-linked material. Studies have demonstrated its biocompatibility and effectiveness as a membrane for bone regeneration including GBR procedures(10-12). Research on porcine peritoneum shows it contains significantly more elastic fibers than pericardium , leading to two to three times greater maximum load and burst pressure. Additionally, it demonstrates superior in vitro resistance to enzymatic degradation, indicating enhanced durability and suitability for biomedical applications(11).
As previously discussed, various bone types can be utilized in guided bone regeneration (GBR). Autogenous grafts are considered the "gold standard" in bone grafting due to their unique combination of osteogenic, osteoinductive, and osteoconductive properties(13-15). However, their limited availability , patient's morbidity , fast resorption rate and the potential for complications at the donor site necessitate the exploration of alternative graft materials(16). Additionally , studies have shown that combining autogenous bone with xenogenic materials in different proportions demonstrated successful tissue integration for the implants, high survival rates and low complication rates (17-20) . Although the bone substitutes has been widely used , the mixture between allogeneic -xenogeneic has been rarely documented until recently . In fact , these studies confirmed the effectiveness of using this combination in guided bone regeneration surgeries, highlighting their synergistic potential in enhancing bone regeneration outcomes(21-28). Furthermore, a study from the Periodontology Department at Saint Joseph University of Beirut on lateral ridge augmentation, utilizing a xenogeneic-allogeneic graft mixture with two different membrane types, has been submitted for publication.
To date, there are no clinical studies comparing the use of non-cross-linked porcine peritoneum collagen membranes with cross-linked bovine-derived membranes in conjunction with a combination of allograft and xenograft materials for guided bone regeneration. This lack of direct comparative research highlights the need for further investigation to assess their relative efficacy and clinical outcomes in regenerative procedures.
This clinical trial aims to evaluate the effectiveness of a porcine peritoneum membrane compared to a cross-linked membrane in guided bone regeneration (GBR) for lateral ridge augmentation. Both membranes will be tested using the same bone graft material, with outcomes measured by assessing volumetric changes in bone width.
- Conditions
- Guided Bone Regeneration, Bone Augmentation
- Being tested
- Lateral Guided bone regeneration
- Keywords
- Lateral guided bone regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Guided bone regenerationProcedure or surgery
Lateral guided bone regeneration using two types of membranes
| Study group | Role | What they receive |
|---|---|---|
| Peritoneun Collagen Membrane group | Active comparator | Peritoneum Collagen Membrane group with a combination of allograft and xenograft Receives: Procedure: Lateral Guided bone regeneration |
| Cross-linked bovine type 1 Collagen Membrane group | Active comparator | Cross-linked bovine type 1 Collagen Membrane group with a combination of allograft and xenograft Receives: Procedure: Lateral Guided bone regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the linear and volumetric bone width changes, clinically and radiographically, between two different membranes : glutaraldehyde cross-linked collagen membrane and a peritonium-derived membrane with the use of a bone graft combination of demineral
Measured: From March 2025 to March 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start10 Mar 2025
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided Bone RegenerationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525128
- Sponsor's protocol ID
- CER-2025-101
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Ridge Augmentation Using Cross-linked or Peritoneum Collagen Membrane With a Composite Allograft-xenograft Mix: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07525128
- Acronym / sponsor ID
- CER-2025-101
- Conditions
- Guided Bone Regeneration, Bone Augmentation
- Keywords
- Lateral guided bone regeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 13 Apr 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.
Bone width is critical for successful implant placement, as thin bone increases the risk of bone loss. Various augmentation techniques-especially guided bone regeneration (GBR)-are effective in restoring bone volume using grafts and barrier membranes. Collagen membranes are commonly used but degrade quickly, leading to the development of improved types like porcine peritoneum membranes, which show better strength and durability. While autogenous grafts are the gold standard, combining different graft materials (e.g., xenograft and allograft) has shown promising results. However, no studies have directly compared porcine peritoneum membranes with cross-linked membranes using such graft combinations. This study aims to evaluate and compare their effectiveness in increasing bone width.
Detailed description
Bone width is of major importance for implant placement, particularly in ensuring the long-term success and stability of the implant. Implants placed in the presence of thin buccal bone width are significantly more prone to exhibit major dimensional changes and vestibular bone loss (1,2). Various lateral bone augmentation techniques, such as guided bone regeneration, ridge expansion, distraction osteogenesis, and block grafting, have consistently demonstrated efficacy in restoring alveolar ridge dimensions(3). Additionally, the application of different types of graft materials-autogenous, xenogeneic, and allogenic-has been extensively documented in the literature for use in the lateral approach, further enhancing the success of these procedures(4).
Guided bone regeneration (GBR) has become a widely accepted and studied clinical method for the management of horizontal ridge deficiency . It is a biological technique designed to facilitate bone regeneration by creating a space that employs bone grafts and barrier membranes during the surgical procedure(5). Various types of barrier membranes are available for GBR, broadly categorized into non-resorbable and resorbable types. Non-resorbable membranes, like those made from polytetrafluoroethylene (PTFE), require a second surgical procedure for removal, while resorbable membranes, such as collagen-based membranes, can be left in place as they are integrated and eventually absorbed by the body(6). Among the various materials tested for use as regenerative tissue barriers, collagen has emerged as an optimal choice, meeting many necessary criteria(7,8). However, a significant limitation is the challenge of sustaining its barrier function for an adequate duration, typically lasting only four weeks due to the rapid biodegradation caused by the enzymatic activity of host tissues and microorganisms. To address this issue, various physical, chemical, and enzymatic cross-linking methods have been developed to prolong the degradation rate of collagen membranes. Consequently, there is a broad array of collagen types available, each differing based on its extraction source, offering versatility for various clinical applications(9). A recent advancement in collagen membranes is the introduction of the porcine peritoneum collagen membrane, a natural, non-cross-linked material. Studies have demonstrated its biocompatibility and effectiveness as a membrane for bone regeneration including GBR procedures(10-12). Research on porcine peritoneum shows it contains significantly more elastic fibers than pericardium , leading to two to three times greater maximum load and burst pressure. Additionally, it demonstrates superior in vitro resistance to enzymatic degradation, indicating enhanced durability and suitability for biomedical applications(11).
As previously discussed, various bone types can be utilized in guided bone regeneration (GBR). Autogenous grafts are considered the "gold standard" in bone grafting due to their unique combination of osteogenic, osteoinductive, and osteoconductive properties(13-15). However, their limited availability , patient's morbidity , fast resorption rate and the potential for complications at the donor site necessitate the exploration of alternative graft materials(16). Additionally , studies have shown that combining autogenous bone with xenogenic materials in different proportions demonstrated successful tissue integration for the implants, high survival rates and low complication rates (17-20) . Although the bone substitutes has been widely used , the mixture between allogeneic -xenogeneic has been rarely documented until recently . In fact , these studies confirmed the effectiveness of using this combination in guided bone regeneration surgeries, highlighting their synergistic potential in enhancing bone regeneration outcomes(21-28). Furthermore, a study from the Periodontology Department at Saint Joseph University of Beirut on lateral ridge augmentation, utilizing a xenogeneic-allogeneic graft mixture with two different membrane types, has been submitted for publication.
To date, there are no clinical studies comparing the use of non-cross-linked porcine peritoneum collagen membranes with cross-linked bovine-derived membranes in conjunction with a combination of allograft and xenograft materials for guided bone regeneration. This lack of direct comparative research highlights the need for further investigation to assess their relative efficacy and clinical outcomes in regenerative procedures.
This clinical trial aims to evaluate the effectiveness of a porcine peritoneum membrane compared to a cross-linked membrane in guided bone regeneration (GBR) for lateral ridge augmentation. Both membranes will be tested using the same bone graft material, with outcomes measured by assessing volumetric changes in bone width.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peritoneun Collagen Membrane group | Active comparator | Procedure: Lateral Guided bone regenerationPeritoneum Collagen Membrane group with a combination of allograft and xenograft |
| Cross-linked bovine type 1 Collagen Membrane group | Active comparator | Procedure: Lateral Guided bone regenerationCross-linked bovine type 1 Collagen Membrane group with a combination of allograft and xenograft |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- - Patients aged 20 to 75 years.
- Healthy individuals, either non-smokers or smokers consuming fewer than 10 cigarettes per day.
- Full mouth bleeding score (FmBS) below 20%.
- Full mouth plaque score (FmPS) below 15%.
- Presence of a residual alveolar ridge with a bone width of less than 6 mm but sufficient bone height in the maxilla or mandible.
Key exclusion criteria (6 listed)
- - Presence of systemic illnesses.
- Smoking more than 10 cigarettes per day.
- Underwent radiotherapy in the head or neck region within the past 5 years.
- Active periodontitis affecting the remaining teeth.
- Pregnancy.
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 |
|---|---|---|
| Lateral Guided bone regenerationLateral guided bone regeneration using two types of membranes | Procedure or surgery | Cross-linked bovine type 1 Collagen Membrane group, Peritoneun Collagen Membrane group |
Primary outcome
Compare the linear and volumetric bone width changes, clinically and radiographically, between two different membranes : glutaraldehyde cross-linked collagen membrane and a peritonium-derived membrane with the use of a bone graft combination of demineral
Time frame: From March 2025 to March 2026
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 16 Apr 2026.
Related trials for Guided Bone Regeneration
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
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Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Surgery, Oral
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
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
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 Phase 4 study testing Lateral Guided bone regeneration in people with Guided Bone Regeneration and Bone Augmentation, run by Saint-Joseph University at 1 site in Lebanon.
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 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 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 Lebanon. 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?
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?
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?
Compare the linear and volumetric bone width changes, clinically and radiographically, between two different membranes : glutaraldehyde cross-linked collagen membrane and a peritonium-derived membrane with the use of a bone graft combination of demineral (time frame: From March 2025 to March 2026). 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 16 Apr 2026.