Alveolar Ridge AtrophyARS-SIMVNCT07692620
Alveolar Ridge Splitting With Simvastatin/PRF Composite and Simultaneous Implant Placement
A study testing Alveolar Ridge Splitting with Simultaneous Implant Placement, Xenogeneic Bone Graft and Platelet-Rich Fibrin (PRF) in people with Alveolar Ridge Atrophy and Tooth Loss, run by Maruwan Ali Alteer at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial evaluated the effectiveness of platelet-rich fibrin (PRF) and a simvastatin/PRF composite combined with a xenogeneic bone graft during alveolar ridge splitting with simultaneous implant placement in patients with horizontal alveolar ridge deficiency. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Alveolar Ridge Atrophy, Tooth Loss
- What is being tested?
- Alveolar Ridge Splitting with Simultaneous Implant Placement, Xenogeneic Bone Graft and Platelet-Rich Fibrin (PRF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2025to 30 May 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Horizontal alveolar ridge width of 3-5 mm. Vertical alveolar bone height of ≥11 mm. Edentulous site located in the mandibular anterior region. Absence of buccal bone undercuts. Male or female participants aged 18-50 years. Good general health and medically fit to undergo oral surgical procedures. Absence of periapical pathology at the intended implant site. Adequate crown height space to achieve a favorable crown-to-implant ratio. Willingness and ability to attend all scheduled follow-up visits. Provision of written informed consent.
Who cannot join
- Uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus), active infection, bleeding disorders, or current anticoagulant therapy.
- Severe systemic diseases (e.g., uncontrolled hypertension or severe cardiovascular disease).
- Severe alveolar bone deficiencies not suitable for ridge splitting. Pregnancy or breastfeeding. Inability to comply with postoperative instructions or follow-up visits. Known allergy or hypersensitivity to simvastatin or study materials. Individuals from vulnerable populations unable to provide valid informed consent.
- Bruxism or other parafunctional oral habits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Surgery, Misr University for Science and Technology
Cairo, Giza Governorate
About this study
Official title: Alveolar Ridge Splitting Augmented With Simvastatin/Platelet-Rich Fibrin Composite With Simultaneous Implant Placement in Horizontal Ridge Augmentation: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial evaluated the effectiveness of platelet-rich fibrin (PRF) and a simvastatin/PRF composite combined with a xenogeneic bone graft during alveolar ridge splitting with simultaneous implant placement in patients with horizontal alveolar ridge deficiency. Twenty-one participants were randomly allocated into three groups: a control group receiving xenogeneic bone graft alone, a PRF group receiving xenogeneic bone graft blended with PRF, and a simvastatin/PRF group receiving xenogeneic bone graft blended with a simvastatin/PRF composite. Clinical and radiographic outcomes were assessed to compare horizontal and vertical bone gain, bone density, and keratinized tissue width after treatment.
Read the detailed description
Horizontal alveolar ridge deficiency frequently complicates implant placement following tooth loss. Alveolar ridge splitting is a well-established technique for horizontal ridge augmentation that allows simultaneous implant placement when sufficient vertical bone height is available. However, the predictability of bone regeneration may be influenced by the grafting material used.
Platelet-rich fibrin (PRF) is an autologous biomaterial rich in platelets, leukocytes, and growth factors that may enhance angiogenesis, soft tissue healing, and bone regeneration. Simvastatin has also demonstrated osteogenic and angiogenic properties through stimulation of bone morphogenetic protein-2 (BMP-2) expression and inhibition of osteoclastic activity. Combining simvastatin with PRF may further improve regenerative outcomes.
This single-center, randomized controlled clinical trial included 21 participants with horizontal alveolar ridge deficiency requiring implant-supported rehabilitation. Participants were randomly allocated into three equal groups (n = 7 per group). Group I underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft. Group II received a xenogeneic bone graft blended with PRF. Group III received a xenogeneic bone graft blended with a simvastatin/PRF composite.
Clinical and radiographic evaluations were performed to assess horizontal bone gain, vertical bone gain, bone density using cone-beam computed tomography (CBCT), and keratinized tissue width. The study aimed to determine whether the addition of PRF alone or in combination with simvastatin could improve regenerative outcomes compared with conventional xenogeneic bone grafting.
- Conditions
- Alveolar Ridge Atrophy, Tooth Loss
- Being tested
- Alveolar Ridge Splitting with Simultaneous Implant Placement, Xenogeneic Bone Graft, Platelet-Rich Fibrin (PRF), Simvastatin
- Keywords
- Alveolar Ridge Splitting, Horizontal Ridge Augmentation, Dental Implants, Platelet-Rich Fibrin, PRF, Bone Regeneration, Xenogeneic Bone Graft, Bone Density, Randomized Controlled Trial
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar Ridge Splitting with Simultaneous Implant PlacementProcedure or surgery
Surgical expansion of the horizontally deficient alveolar ridge followed by immediate dental implant placement.
Xenogeneic Bone GraftBiological
Xenogeneic bone graft used to augment the expanded alveolar ridge around the implant.
Platelet-Rich Fibrin (PRF)Biological
Autologous platelet-rich fibrin prepared from the participant's blood and blended with the xenogeneic bone graft.
SimvastatinDrug
Locally applied simvastatin incorporated into the PRF/xenogeneic bone graft composite to enhance bone regeneration.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Participants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft. Receives: Procedure: Alveolar Ridge Splitting with Simultaneous Implant Placement; Biological: Xenogeneic Bone Graft |
| PRF Group | Experimental | Participants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft blended with platelet-rich fibrin (PRF). Receives: Procedure: Alveolar Ridge Splitting with Simultaneous Implant Placement; Biological: Xenogeneic Bone Graft; Biological: Platelet-Rich Fibrin (PRF) |
| Simvastatin/PRF Group | Experimental | Participants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft blended with a simvastatin/platelet-rich fibrin (PRF) composite. Receives: Procedure: Alveolar Ridge Splitting with Simultaneous Implant Placement; Biological: Xenogeneic Bone Graft; Biological: Platelet-Rich Fibrin (PRF); Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal Bone Gain
Horizontal bone gain was assessed by measuring the change in alveolar ridge width using cone-beam computed tomography (CBCT). Measurements were obtained by superimposition of preoperative and 6-month postoperative CBCT scans at standardized reference levels.
Measured: 6 months after surgery
Vertical Bone Gain
Vertical bone gain was assessed by comparing preoperative and 6-month postoperative CBCT scans using standardized reference points.
Measured: 6 months after surgery
Secondary outcomes (3)
Bone Density
Bone density of the augmented site was evaluated using CBCT gray scale values.
Measured: 6 months after surgery
Keratinized Tissue Width
Keratinized tissue width was measured clinically using a calibrated periodontal probe.
Measured: Baseline and 6 months after surgery
Implant Stability
Implant stability was assessed using the Implant Stability Test (IST) device. Measurements were recorded as IST values immediately after implant placement and at the 6-month follow-up.
Measured: Baseline (immediately after implant placement) and 6 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 posted9 Jul 2026
- Study start2 Jun 2025
- Primary completion2 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge AtrophyStudies 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
- Model description
- Participants were randomly assigned to one of three parallel groups. Each group received alveolar ridge splitting with simultaneous implant placement, differing only in the augmentation material used (xenogeneic bone graft alone, xenogeneic bone graft blended with PRF, or xenogeneic bone graft blended with a simvastatin/PRF composite).
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maruwan Ali Alteer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maruwan Ali Alteer, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692620
- Sponsor's protocol ID
- MUST-IRB-2024-0062
- Other IDs
- 2024/0062
- Acronym
- ARS-SIMV
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) with other researchers. De-identified participant data will not be made publicly available. Study results will be disseminated through peer-reviewed publications and conference presentations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Splitting Augmented With Simvastatin/Platelet-Rich Fibrin Composite With Simultaneous Implant Placement in Horizontal Ridge Augmentation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07692620
- Acronym / sponsor ID
- ARS-SIMV / MUST-IRB-2024-0062
- Conditions
- Alveolar Ridge Atrophy, Tooth Loss
- Keywords
- Alveolar Ridge Splitting, Horizontal Ridge Augmentation, Dental Implants, Platelet-Rich Fibrin, PRF, Bone Regeneration, Xenogeneic Bone Graft, Bone Density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Maruwan Ali AlteerUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 2 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 9 Jul 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 randomized controlled clinical trial evaluated the effectiveness of platelet-rich fibrin (PRF) and a simvastatin/PRF composite combined with a xenogeneic bone graft during alveolar ridge splitting with simultaneous implant placement in patients with horizontal alveolar ridge deficiency. Twenty-one participants were randomly allocated into three groups: a control group receiving xenogeneic bone graft alone, a PRF group receiving xenogeneic bone graft blended with PRF, and a simvastatin/PRF group receiving xenogeneic bone graft blended with a simvastatin/PRF composite. Clinical and radiographic outcomes were assessed to compare horizontal and vertical bone gain, bone density, and keratinized tissue width after treatment.
Detailed description
Horizontal alveolar ridge deficiency frequently complicates implant placement following tooth loss. Alveolar ridge splitting is a well-established technique for horizontal ridge augmentation that allows simultaneous implant placement when sufficient vertical bone height is available. However, the predictability of bone regeneration may be influenced by the grafting material used.
Platelet-rich fibrin (PRF) is an autologous biomaterial rich in platelets, leukocytes, and growth factors that may enhance angiogenesis, soft tissue healing, and bone regeneration. Simvastatin has also demonstrated osteogenic and angiogenic properties through stimulation of bone morphogenetic protein-2 (BMP-2) expression and inhibition of osteoclastic activity. Combining simvastatin with PRF may further improve regenerative outcomes.
This single-center, randomized controlled clinical trial included 21 participants with horizontal alveolar ridge deficiency requiring implant-supported rehabilitation. Participants were randomly allocated into three equal groups (n = 7 per group). Group I underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft. Group II received a xenogeneic bone graft blended with PRF. Group III received a xenogeneic bone graft blended with a simvastatin/PRF composite.
Clinical and radiographic evaluations were performed to assess horizontal bone gain, vertical bone gain, bone density using cone-beam computed tomography (CBCT), and keratinized tissue width. The study aimed to determine whether the addition of PRF alone or in combination with simvastatin could improve regenerative outcomes compared with conventional xenogeneic bone grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly assigned to one of three parallel groups. Each group received alveolar ridge splitting with simultaneous implant placement, differing only in the augmentation material used (xenogeneic bone graft alone, xenogeneic bone graft blended with PRF, or xenogeneic bone graft blended with a simvastatin/PRF composite).
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: Alveolar Ridge Splitting with Simultaneous Implant Placement, Biological: Xenogeneic Bone GraftParticipants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft. |
| PRF Group | Experimental | Procedure: Alveolar Ridge Splitting with Simultaneous Implant Placement, Biological: Xenogeneic Bone Graft, Biological: Platelet-Rich Fibrin (PRF)Participants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft blended with platelet-rich fibrin (PRF). |
| Simvastatin/PRF Group | Experimental | Procedure: Alveolar Ridge Splitting with Simultaneous Implant Placement, Biological: Xenogeneic Bone Graft, Biological: Platelet-Rich Fibrin (PRF), Drug: SimvastatinParticipants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft blended with a simvastatin/platelet-rich fibrin (PRF) composite. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Horizontal alveolar ridge width of 3-5 mm. Vertical alveolar bone height of ≥11 mm. Edentulous site located in the mandibular anterior region. Absence of buccal bone undercuts. Male or female participants aged 18-50 years. Good general health and medically fit to undergo oral surgical procedures. Absence of periapical pathology at the intended implant site. Adequate crown height space to achieve a favorable crown-to-implant ratio. Willingness and ability to attend all scheduled follow-up visits. Provision of written informed consent.
Key exclusion criteria (4 listed)
- Uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus), active infection, bleeding disorders, or current anticoagulant therapy.
- Severe systemic diseases (e.g., uncontrolled hypertension or severe cardiovascular disease).
- Severe alveolar bone deficiencies not suitable for ridge splitting. Pregnancy or breastfeeding. Inability to comply with postoperative instructions or follow-up visits. Known allergy or hypersensitivity to simvastatin or study materials. Individuals from vulnerable populations unable to provide valid informed consent.
- Bruxism or other parafunctional oral habits.
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 |
|---|---|---|
| Alveolar Ridge Splitting with Simultaneous Implant PlacementSurgical expansion of the horizontally deficient alveolar ridge followed by immediate dental implant placement. | Procedure or surgery | PRF Group, Simvastatin/PRF Group, control group |
| Xenogeneic Bone GraftXenogeneic bone graft used to augment the expanded alveolar ridge around the implant. | Biological | PRF Group, Simvastatin/PRF Group, control group |
| Platelet-Rich Fibrin (PRF)Autologous platelet-rich fibrin prepared from the participant's blood and blended with the xenogeneic bone graft. | Biological | PRF Group, Simvastatin/PRF Group |
| SimvastatinLocally applied simvastatin incorporated into the PRF/xenogeneic bone graft composite to enhance bone regeneration. | Drug | Simvastatin/PRF Group |
Primary outcome
Horizontal Bone Gain
Time frame: 6 months after surgery
Horizontal bone gain was assessed by measuring the change in alveolar ridge width using cone-beam computed tomography (CBCT). Measurements were obtained by superimposition of preoperative and 6-month postoperative CBCT scans at standardized reference levels.
Vertical Bone Gain
Time frame: 6 months after surgery
Vertical bone gain was assessed by comparing preoperative and 6-month postoperative CBCT scans using standardized reference points.
3 secondary outcomes
Bone Density
Time frame: 6 months after surgery
Keratinized Tissue Width
Time frame: Baseline and 6 months after surgery
Implant Stability
Time frame: Baseline (immediately after implant placement) and 6 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 9 Jul 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) with other researchers. De-identified participant data will not be made publicly available. Study results will be disseminated through peer-reviewed publications and conference presentations.
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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 Alveolar Ridge Splitting with Simultaneous Implant Placement, Xenogeneic Bone Graft and Platelet-Rich Fibrin (PRF) in people with Alveolar Ridge Atrophy and Tooth Loss, run by Maruwan Ali Alteer at 1 site in Egypt.
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 4 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 9 Jul 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 Egypt. 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?
Horizontal Bone Gain (time frame: 6 months after surgery). 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 9 Jul 2026.