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Completed

NCT Number: NCT04992416

Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites

Recently, autogenous tooth graft (ATG) made from compromised teeth was applied in bone defects and resulted in a good clinical efficacy.(6) Moreover, it is more accepted by patients to use extracted teeth as a bone graft material, especially in the case of immediate implant placement. Simvastatin (SMV), known as a 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase inhibitor, is widely used to decrease serum cholesterol because of its safe and effective treatment. Apart from cholesterol-lowering effects, SMV is also found to promote osteogenic differentiation of bone marrow stem cells (BMSCs), suppress osteoclastic differentiation in bone tissue and promotes osseointegration around implants in animal studies. SMV is reported to enhance autophagy and alleviates the ROS of BMSCs in the osseointegration of implants. The present study will be carried out to evaluate the effect of SMV combined with ATG on bone formation around immediately placed dental implants.

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Key information

Conditions

Autogenous Tooth Bone Graft Immediate Implant Placement Simvastatin

Age range

18 year–50 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

  • Teeth need to be extracted for periodontal reasons with a defect of labial bone (horizontal or vertical bone defect).
  • the teeth without acute inflammation.
  • no uncontrolled systemic disease which is not suitable for implantation.
  • Good systemic and oral health.

Exclusion criteria

  • patients with systemic diseases or medications known to alter healing processes.
  • Psychiatric disorders.
  • Root canal treated teeth.
  • patients undergoing or who had undergone radiation therapy and chemotherapy to the head and neck region during 12 months.
  • patients with para-functional habits.
  • alcoholics.
  • drug abusers.
  • heavy smokers

Treatment and study plan

immediate implant placement with ATBG and SMV

Procedure

immediate implant placement using ATBG as a graft material, with SMV

immediate implant placement with ATBG

Procedure

immediate implant placement using ATBG as a graft material without SMV

Primary outcomes

  1. clinical evaluation of bone formation around immediately placed dental implants

    Time frame: 9 months

    Changes on bone formation using ATBG with or without SMV around immediately placed dental implants in periodontally compromised teeth

  2. radiographic outcome around immediately placed dental implants

    Time frame: 9 months

    the radiographic outcome of ATBG on bone formation with or without SMV around immediately placed dental implants in periodontally compromised teeth

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites: A Randomized Controlled Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2021
Registry last updated
Aug 31, 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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