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

NCT07692620 | Completed

• 2 other identifiers: MUST-IRB-2024-00622024/0062
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Bone Density

  6 months after surgery

• Keratinized Tissue Width

  Baseline and 6 months after surgery

• Implant Stability

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

Study Arms (3)

control group

ACTIVE COMPARATOR

Participants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft.

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).

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.

Procedure: Alveolar Ridge Splitting with Simultaneous Implant Placement; Biological: Xenogeneic Bone Graft; Biological: Platelet-Rich Fibrin (PRF); Drug: Simvastatin

Interventions

Alveolar Ridge Splitting with Simultaneous Implant Placement PROCEDURE

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

PRF Group; Simvastatin/PRF Group; control group

Xenogeneic Bone Graft BIOLOGICAL

Xenogeneic bone graft used to augment the expanded alveolar ridge around the implant.

PRF Group; Simvastatin/PRF Group; control group

Platelet-Rich Fibrin (PRF) BIOLOGICAL

Autologous platelet-rich fibrin prepared from the participant's blood and blended with the xenogeneic bone graft.

PRF Group; Simvastatin/PRF Group

Simvastatin DRUG

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

Simvastatin/PRF Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maruwan Ali Alteer: lead

Study Sites (1)

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

Cairo, Giza Governorate, Egypt

Location

MeSH Terms

Conditions

Tooth Loss

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. The surgeon and participants were aware of the assigned intervention because of the nature of the surgical procedures and biomaterials used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: aster's Degree Candidate, Department of Periodontology, Faculty of Oral and Dental Surgery

Model Details: 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).

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: June 2, 2025
• Primary Completion: May 2, 2026
• Study Completion: May 30, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)