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Completed

NCT Number: NCT07692620

Alveolar Ridge Splitting With Simvastatin/PRF Composite and Simultaneous Implant Placement

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Surgery, Misr University for Science and Technology

Cairo, Giza Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alveolar Ridge Splitting with Simultaneous Implant Placement

Procedure

Surgical expansion of the horizontally deficient alveolar ridge followed by immediate dental implant placement.

Xenogeneic Bone Graft

Biological

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.

simvastatin

Drug

Locally applied simvastatin incorporated into the PRF/xenogeneic bone graft composite to enhance bone regeneration.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Bone Density

    Time frame: 6 months after surgery

    Bone density of the augmented site was evaluated using CBCT gray scale values.

  2. Keratinized Tissue Width

    Time frame: Baseline and 6 months after surgery

    Keratinized tissue width was measured clinically using a calibrated periodontal probe.

  3. Implant Stability

    Time frame: Baseline (immediately after implant placement) and 6 months after surgery.

    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.

Sponsors and collaborators

Lead sponsor

Maruwan Ali Alteer

Other

Registry information

Official study title

Alveolar Ridge Splitting Augmented With Simvastatin/Platelet-Rich Fibrin Composite With Simultaneous Implant Placement in Horizontal Ridge Augmentation: A Randomized Controlled Clinical Trial

Acronym: ARS-SIMV

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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