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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Giza Governorate
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Cairo, Giza Governorate, Egypten
- Faculty of Oral and Dental Surgery, Misr University for Science and Technology
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: control group
Participants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft.
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Surgical expansion of the horizontally deficient alveolar ridge followed by immediate dental implant placement.
Xenogeneic bone graft used to augment the expanded alveolar ridge around the implant.
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Eksperimentel: PRF Group
Participants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft blended with platelet-rich fibrin (PRF).
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Surgical expansion of the horizontally deficient alveolar ridge followed by immediate dental implant placement.
Xenogeneic bone graft used to augment the expanded alveolar ridge around the implant.
Autologous platelet-rich fibrin prepared from the participant's blood and blended with the xenogeneic bone graft.
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Eksperimentel: 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.
|
Surgical expansion of the horizontally deficient alveolar ridge followed by immediate dental implant placement.
Xenogeneic bone graft used to augment the expanded alveolar ridge around the implant.
Autologous platelet-rich fibrin prepared from the participant's blood and blended with the xenogeneic bone graft.
Locally applied simvastatin incorporated into the PRF/xenogeneic bone graft composite to enhance bone regeneration.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Horizontal Bone Gain
Tidsramme: 6 months after surgery
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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.
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6 months after surgery
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Vertical Bone Gain
Tidsramme: 6 months after surgery
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Vertical bone gain was assessed by comparing preoperative and 6-month postoperative CBCT scans using standardized reference points.
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6 months after surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Bone Density
Tidsramme: 6 months after surgery
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Bone density of the augmented site was evaluated using CBCT gray scale values.
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6 months after surgery
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Keratinized Tissue Width
Tidsramme: Baseline and 6 months after surgery
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Keratinized tissue width was measured clinically using a calibrated periodontal probe.
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Baseline and 6 months after surgery
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Implant Stability
Tidsramme: Baseline (immediately after implant placement) and 6 months after surgery.
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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.
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Baseline (immediately after implant placement) and 6 months after surgery.
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MUST-IRB-2024-0062
- 2024/0062 (Anden identifikator: Misr University for Science and Technology Institutional Review Board (MUST-IRB))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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