Alveolar Bone ResorptionPhase 2/3NCT06523686
Lateral Ridge Augmentation Using Two Graft Combination and a Cross-linked Collagen Membrane
A Phase 2/3 study testing Guided bone regeneration in people with Alveolar Bone Resorption, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
To treat resorbed alveolar ridges, many surgical procedures are available in the literature such as ridge splitting, distraction osteogenesis, block grafting techniques and guided bone regeneration, which is the most documented technique. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption
- What is being tested?
- Guided bone regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteLebanon
- Study dates
- 9 Jan 2023to 10 Jul 2024
- Phase
- Phase 2/3
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients, non-smokers or smokers <10 cigarettes/day.
- Age between 20 and 75.
- Full mouth bleeding score (FmBS) <20 %.
- Full mouth plaque score (FmPS) <15%.
- Residual bone width < 5 mm and adequate bone height in the maxilla and the mandible.
- Tooth extraction performed at least 6 weeks before surgery.
- Presence of enough teeth to support an occlusal stent/radiographic guide.
Who cannot join
- Systemic diseases.
- Heavy smokers (> 10 cigarettes/day).
- History of radiotherapy in the head and neck region in the last 5 years.
- Active periodontitis on the remaining teeth.
- Pregnancy.
- Intake of medications that may have an effect on bone turnover and mucosal healing (i.e., tetracycline within the last month, steroids within the last 6 months, bisphosphonates or fluorides at bone therapeutic levels, vitamin D and metabolites at therapeutic levels within the last 6 months).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lateral Ridge Augmentation Using Autogenous-xenogeneic or Allogeneic-xenogeneic Graft Mix With a Cross-linked Collagen Membrane: a Randomized Pilot Clinical Trial
To treat resorbed alveolar ridges, many surgical procedures are available in the literature such as ridge splitting, distraction osteogenesis, block grafting techniques and guided bone regeneration, which is the most documented technique. Various grafting materials are available but there is a lack of evidence on the superiority of a material or a combination of materials.
Read the detailed description
Bone width at the implant site is an important prerequisite for a predictable and long-term prognosis in implant dentistry. Different types of membranes and bone grafts are used in the GBR procedure. However, there is a lack of studies in the literature about the combination allograft/xenograft. The aim of the present trial is to compare two different bone graft combinations (autogenous-xenogeneic and allogeneic-xenogeneic) covered with a cross-linked collagen membrane in a horizontal alveolar ridge augmentation (without simultaneous implant placement).
- Conditions
- Alveolar Bone Resorption
- Being tested
- Guided bone regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided bone regenerationProcedure or surgery
Compare the linear and volumetric bone width changes, clinically and radiographically, between two different bone graft combinations (autogenous-xenogeneic and allogeneic-xenogeneic) covered with a cross-linked collagen membrane in a horizontal GBR.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic-xenogeneic combination | Experimental | A mix of 2/3 allogeneic bone with 1/3 xenogeneic bone Receives: Procedure: Guided bone regeneration |
| Autogenous-xenogeneic combination | Experimental | A mix of 2/3 autogenous bone and 1/3 xenogeneic bone Receives: Procedure: Guided bone regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear bone width changes
Linear bone width changes assessed clinically and radiographically in mm
Measured: 6 months
Volumetric bone changes
Volumetric bone changes assessed radiographically in cubic mm
Measured: 6 months
Secondary outcomes (2)
Clinical Ridge Height gain
Clinical Ridge Height gain in mm
Measured: 6 months
Probe penetration
Probe penetration at the occlusion-buccal angle
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 posted26 Jul 2024
- Study start9 Jan 2023
- Primary completion10 Jun 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone ResorptionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celine Rassi, Saint-Joseph University
- Investigators
- Celine Rassi, DDS, Principal investigator, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523686
- Sponsor's protocol ID
- USJ-2023-57
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Ridge Augmentation Using Autogenous-xenogeneic or Allogeneic-xenogeneic Graft Mix With a Cross-linked Collagen Membrane: a Randomized Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT06523686
- Acronym / sponsor ID
- USJ-2023-57
- Conditions
- Alveolar Bone Resorption
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 26 Jul 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.
To treat resorbed alveolar ridges, many surgical procedures are available in the literature such as ridge splitting, distraction osteogenesis, block grafting techniques and guided bone regeneration, which is the most documented technique. Various grafting materials are available but there is a lack of evidence on the superiority of a material or a combination of materials.
Detailed description
Bone width at the implant site is an important prerequisite for a predictable and long-term prognosis in implant dentistry. Different types of membranes and bone grafts are used in the GBR procedure. However, there is a lack of studies in the literature about the combination allograft/xenograft. The aim of the present trial is to compare two different bone graft combinations (autogenous-xenogeneic and allogeneic-xenogeneic) covered with a cross-linked collagen membrane in a horizontal alveolar ridge augmentation (without simultaneous implant placement).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogeneic-xenogeneic combination | Experimental | Procedure: Guided bone regenerationA mix of 2/3 allogeneic bone with 1/3 xenogeneic bone |
| Autogenous-xenogeneic combination | Experimental | Procedure: Guided bone regenerationA mix of 2/3 autogenous bone and 1/3 xenogeneic bone |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy patients, non-smokers or smokers <10 cigarettes/day.
- Age between 20 and 75.
- Full mouth bleeding score (FmBS) <20 %.
- Full mouth plaque score (FmPS) <15%.
- Residual bone width < 5 mm and adequate bone height in the maxilla and the mandible.
Key exclusion criteria (6 listed)
- Systemic diseases.
- Heavy smokers (> 10 cigarettes/day).
- History of radiotherapy in the head and neck region in the last 5 years.
- Active periodontitis on 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 |
|---|---|---|
| Guided bone regenerationCompare the linear and volumetric bone width changes, clinically and radiographically, between two different bone graft combinations (autogenous-xenogeneic and allogeneic-xenogeneic) covered with a cross-linked collagen membrane in a horizontal GBR. | Procedure or surgery | Allogeneic-xenogeneic combination, Autogenous-xenogeneic combination |
Primary outcome
Linear bone width changes
Time frame: 6 months
Linear bone width changes assessed clinically and radiographically in mm
Volumetric bone changes
Time frame: 6 months
Volumetric bone changes assessed radiographically in cubic mm
2 secondary outcomes
Clinical Ridge Height gain
Time frame: 6 months
Probe penetration
Time frame: 6 months
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 26 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Alveolar Bone Resorption
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
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Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
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
Recruiting
Melatonin Effect on Immediate Dental Implants in the Posterior Mandible
Dental Implant, Immediate Dental 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.
Celine Rassi, DDS principal investigator
Saint-Joseph University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Guided bone regeneration in people with Alveolar Bone Resorption, 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: finished, as of the sponsor's last update on 26 Jul 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 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Linear bone width changes (time frame: 6 months). The study lists 2 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 26 Jul 2024.