Alveolar Ridge Splitting With Simvastatin/PRF Composite and Simultaneous Implant Placement (ARS-SIMV)

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.

Study Overview

• Status: Completed
• Conditions: Tooth Loss; Alveolar Ridge Atrophy
• Intervention / Treatment: Procedure: Alveolar Ridge Splitting with Simultaneous Implant Placement; Biological: Xenogeneic Bone Graft; Biological: Platelet-Rich Fibrin (PRF); Drug: Simvastatin

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza Governorate
    • Cairo, Giza Governorate, Egypt
      • Faculty of Oral and Dental Surgery, Misr University for Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; Participants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft.	Procedure: Alveolar Ridge Splitting with Simultaneous Implant Placement; Surgical expansion of the horizontally deficient alveolar ridge followed by immediate dental implant placement.; Biological: Xenogeneic Bone Graft; Xenogeneic bone graft used to augment the expanded alveolar ridge around the implant.
Experimental: PRF Group; Participants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft blended with platelet-rich fibrin (PRF).	Procedure: Alveolar Ridge Splitting with Simultaneous Implant Placement; Surgical expansion of the horizontally deficient alveolar ridge followed by immediate dental implant placement.; Biological: Xenogeneic Bone Graft; Xenogeneic bone graft used to augment the expanded alveolar ridge around the implant.; Biological: Platelet-Rich Fibrin (PRF); Autologous platelet-rich fibrin prepared from the participant's blood and blended with the xenogeneic bone graft.
Experimental: Simvastatin/PRF Group; 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.	Procedure: Alveolar Ridge Splitting with Simultaneous Implant Placement; Surgical expansion of the horizontally deficient alveolar ridge followed by immediate dental implant placement.; Biological: Xenogeneic Bone Graft; Xenogeneic bone graft used to augment the expanded alveolar ridge around the implant.; Biological: Platelet-Rich Fibrin (PRF); Autologous platelet-rich fibrin prepared from the participant's blood and blended with the xenogeneic bone graft.; Drug: Simvastatin; Locally applied simvastatin incorporated into the PRF/xenogeneic bone graft composite to enhance bone regeneration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Density	Bone density of the augmented site was evaluated using CBCT gray scale values.	6 months after surgery
Keratinized Tissue Width	Keratinized tissue width was measured clinically using a calibrated periodontal probe.	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.	Baseline (immediately after implant placement) and 6 months after surgery.

Collaborators and Investigators

• Sponsor: Maruwan Ali Alteer

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Actual): May 2, 2026
• Study Completion (Actual): May 30, 2026

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; PRF; Dental Implants; Bone Density; Bone Regeneration; Platelet-Rich Fibrin; Alveolar Ridge Splitting; Xenogeneic Bone Graft; Horizontal Ridge Augmentation
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Tooth Loss; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Lovastatin; Simvastatin
• Other Study ID Numbers: MUST-IRB-2024-0062; 2024/0062 (Other Identifier: Misr University for Science and Technology Institutional Review Board (MUST-IRB))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No