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The Effect of Simvastatin With Guided Bone Regeneration in Ridge Splitting and Simultaneously Implantation

The Effect of Simvastatin With Guided Bone Regeneration on Ridge Volume in Ridge Splitting and Simultaneously Implantation: a Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05020405
Enrollment
22
Registered
2021-08-25
Start date
2020-10-01
Completion date
2022-02-20
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate Implant, Ridge Splitting, Simvastatin

Brief summary

Ridge split augmentation technique, with immediate implant placement, reduces the time of the treatment and the time of the final prosthetic reconstruction. Furthermore, compression of the bone increases its density. SMV is also found to promote osteogenic differentiation of bone marrow stem cells, suppress osteoclastic differentiation in bone tissue, and promotes osseointegration around implants in animal studies. The aim of this study is to compare surgical outcomes of the application of the alveolar ridge splitting (ARS) in combination with guided bone regeneration (GBR) using bone grafting and a barrier membrane, associated with immediate implant placement versus ARS in combination with the use of SMV with GBR using bone grafting and a barrier membrane, associated with immediate implant placement in patients with horizontally atrophic jaw bones.

Interventions

PROCEDUREImmediate implant placement and ARS with GBR and SMV

Implant insertion and GBR for augmentation of the gap between buccal and lingual plate using bone graft mixed with SMV

PROCEDUREImmediate implant placement and ARS with GBR

Implant insertion and GBR for augmentation of the gap between buccal and lingual plate

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* good general health at the time of surgery. * at least 3 months of healing after tooth extraction. * horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.

Exclusion criteria

* a vertical bone defect in the edentulous ridge. * thick cortex in the labial/buccal with less cancellous bone inside * obvious undercut on the labial/buccal side. * uncontrolled periodontal conditions or other oral disorders. * history of radiotherapy in the head and neck region. * uncontrolled diabetes mellitus or other systematic disorders. * smokers. * Pregnancy. * non-compliant patients. * allergic reaction to the medications used.

Design outcomes

Primary

MeasureTime frameDescription
Measurements of the amount of bone formation in millimeters around immediately placed dental implants9 monthsMeasurements of the amount of bone formation in millimeters using GBR with or without the combined effect of SMV in the ridge splitting following immediate implant placement.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026