Ridge PreservationNCT05889377
Socket Preservation Technique Using Bovine Bone, Platelet Rich Fibrin Or A Combination Of Both: A Clinical, Radiographic And Histological Assesment At 4 Months
A study testing Socket preservation in people with Ridge Preservation and Post Extraction Alveolar Bone Resorption, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
Post extraction alveolar bone resorption is one of the main challenges that face oral implantologists in their daily surgical practice (1). To palliate to post-extraction resorption, advanced bone grafting and regeneration techniques have been described (2). Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Ridge Preservation, Post Extraction Alveolar Bone Resorption
- What is being tested?
- Socket preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteLebanon
- Study dates
- 3 Nov 2021to 20 Dec 2024
- 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 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients will require single tooth extraction and subsequent implant rehabilitation.
- Patients over 18 years of age.
- Patients willing to comply with the study requirements (signed consent form)
- Good oral hygiene and no signs of active periodontal infection
- No compromising medical status
- < 10 cigarettes smoking per day
Who cannot join
- acute myocardial infarction within the last two months;
- Uncontrolled coagulation disorders;
- uncontrolled diabetes (HBA1c> 7.5);
- radiation therapy to the head \ neck region in the last 24 months;
- immunocompromised patients, HIV positive or receiving chemotherapy in the last five years;
- past or present treatment with intravenous bisphosphonates;
- psychological or psychiatric problems;
- abuse of alcohol or drugs;
Trial locations and contacts
1 site in 1 country.
About this study
Post extraction alveolar bone resorption is one of the main challenges that face oral implantologists in their daily surgical practice (1). To palliate to post-extraction resorption, advanced bone grafting and regeneration techniques have been described (2). However, these procedures, although well documented and validated, still have relatively high complication rates and patient morbidity, in addition to the elevated cost and duration of treatment (3). Socket preservation is a very useful technique in order to counter post extraction resorption issues, therefore eliminating the need for future complicated and delicate regeneration procedures (4). Many biomaterials were proposed for socket preservation such as allografts and bovine hydroxyapatite (5). Recently autologous platelet concentrates such as Platelet Rich Fibrin PRF were described as a potential socket filler material (6).
In the proposed protocol, fresh extraction sockets will be either grafted by a bovine bone substitute, a PRF plug or a mixture of both. Sockets will then be clinically and radiographically monitored over time to assess three-dimensional soft and hard tissue stability. Bone quality will be histologically examined at 6 months implant placement. A no graft group will serve as control.
The results of this study may be of major importance since they could give an objective idea of the most efficient socket preservation technique, thus offering simple and secure oral rehabilitation solutions for both patient and practitioner.
- Being tested
- Socket preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket preservationProcedure or surgery
Socket preservation will be done after tooth extraction. For each group we will use a bone substitute.
| Study group | Role | What they receive |
|---|---|---|
| Bovine Bone | Experimental | Not described Receives: Procedure: Socket preservation |
| Platelet Rich Fibrin | Experimental | Not described Receives: Procedure: Socket preservation |
| Bovine Bone + PRF | Experimental | Not described Receives: Procedure: Socket preservation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hard tissue change by measuring bone profil retraction between 0,4 and 12 months using 3D slicer software
Comparison of the bone profile change by CBCT dicom files superimposition at different time frame
Measured: 4 and 12 months
Soft tissue change by measuring gingival retraction between 0,4 and 12 months using 3D slicer sftware
Comparison of the soft tissue profile change by STL files superimposition at different time frame
Measured: 4 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start3 Nov 2021
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge PreservationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Makary, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889377
- Sponsor's protocol ID
- XFMD218
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socket Preservation Technique Using Bovine Bone, Platelet Rich Fibrin Or A Combination Of Both: A Clinical, Radiographic And Histological Assesment At 4 Months
- ClinicalTrials.gov ID
- NCT05889377
- Acronym / sponsor ID
- XFMD218
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 5 Jun 2023 (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.
Post extraction alveolar bone resorption is one of the main challenges that face oral implantologists in their daily surgical practice (1). To palliate to post-extraction resorption, advanced bone grafting and regeneration techniques have been described (2). However, these procedures, although well documented and validated, still have relatively high complication rates and patient morbidity, in addition to the elevated cost and duration of treatment (3). Socket preservation is a very useful technique in order to counter post extraction resorption issues, therefore eliminating the need for future complicated and delicate regeneration procedures (4). Many biomaterials were proposed for socket preservation such as allografts and bovine hydroxyapatite (5). Recently autologous platelet concentrates such as Platelet Rich Fibrin PRF were described as a potential socket filler material (6).
In the proposed protocol, fresh extraction sockets will be either grafted by a bovine bone substitute, a PRF plug or a mixture of both. Sockets will then be clinically and radiographically monitored over time to assess three-dimensional soft and hard tissue stability. Bone quality will be histologically examined at 6 months implant placement. A no graft group will serve as control.
The results of this study may be of major importance since they could give an objective idea of the most efficient socket preservation technique, thus offering simple and secure oral rehabilitation solutions for both patient and practitioner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bovine Bone | Experimental | Procedure: Socket preservation |
| Platelet Rich Fibrin | Experimental | Procedure: Socket preservation |
| Bovine Bone + PRF | Experimental | Procedure: Socket preservation |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients will require single tooth extraction and subsequent implant rehabilitation.
- Patients over 18 years of age.
- Patients willing to comply with the study requirements (signed consent form)
- Good oral hygiene and no signs of active periodontal infection
- No compromising medical status
Key exclusion criteria (8 listed)
- acute myocardial infarction within the last two months;
- Uncontrolled coagulation disorders;
- uncontrolled diabetes (HBA1c> 7.5);
- radiation therapy to the head \ neck region in the last 24 months;
- immunocompromised patients, HIV positive or receiving chemotherapy in the last five years;
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 |
|---|---|---|
| Socket preservationSocket preservation will be done after tooth extraction. For each group we will use a bone substitute. | Procedure or surgery | Bovine Bone, Bovine Bone + PRF, Platelet Rich Fibrin |
Primary outcome
Hard tissue change by measuring bone profil retraction between 0,4 and 12 months using 3D slicer software
Time frame: 4 and 12 months
Comparison of the bone profile change by CBCT dicom files superimposition at different time frame
Soft tissue change by measuring gingival retraction between 0,4 and 12 months using 3D slicer sftware
Time frame: 4 and 12 months
Comparison of the soft tissue profile change by STL files superimposition at different time frame
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 16 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Ridge Preservation
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Alveolar Ridge Preservation Using Sticky Bone and Chitosan
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Volumetric Efficacy of Alveolar Ridge Preservation
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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 Socket preservation in people with Ridge Preservation and Post Extraction 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 6 inclusion and 8 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 16 May 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 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.
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?
Hard tissue change by measuring bone profil retraction between 0,4 and 12 months using 3D slicer software (time frame: 4 and 12 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 16 May 2025; AzTrials last refreshed its copy on 31 Oct 2026.