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OpenTrials
Completed

NCT Number: NCT05020405

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

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.

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Key information

Conditions

Ridge Splitting Immediate Implant Simvastatin

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, 33511, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Immediate implant placement and ARS with GBR and SMV

Procedure

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

Immediate implant placement and ARS with GBR

Procedure

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

Primary outcomes

  1. Measurements of the amount of bone formation in millimeters around immediately placed dental implants

    Time frame: 9 months

    Measurements 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.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2021
Registry last updated
Jul 18, 2023

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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