Alveolar Ridge Atrophy, Tooth Loss
Conditions
Keywords
Alveolar Ridge Splitting, Horizontal Ridge Augmentation, Dental Implants, Platelet-Rich Fibrin, PRF, Bone Regeneration, Xenogeneic Bone Graft, Bone Density, Randomized Controlled Trial
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.
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.
Interventions
PROCEDUREAlveolar Ridge Splitting with Simultaneous Implant Placement
Surgical expansion of the horizontally deficient alveolar ridge followed by immediate dental implant placement.
BIOLOGICALXenogeneic Bone Graft
Xenogeneic bone graft used to augment the expanded alveolar ridge around the implant.
BIOLOGICALPlatelet-Rich Fibrin (PRF)
Autologous platelet-rich fibrin prepared from the participant's blood and blended with the xenogeneic bone graft.
DRUGSimvastatin
Locally applied simvastatin incorporated into the PRF/xenogeneic bone graft composite to enhance bone regeneration.
Sponsors
Maruwan Ali Alteer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Not applicable. The surgeon and participants were aware of the assigned intervention because of the nature of the surgical procedures and biomaterials used.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal Bone Gain | 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 | 6 months after surgery | Vertical bone gain was assessed by comparing preoperative and 6-month postoperative CBCT scans using standardized reference points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone Density | 6 months after surgery | Bone density of the augmented site was evaluated using CBCT gray scale values. |
| Keratinized Tissue Width | Baseline and 6 months after surgery | Keratinized tissue width was measured clinically using a calibrated periodontal probe. |
| Implant Stability | 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. |
Countries
Egypt
Outcome results
None listed