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

K

Kafrelsheikh University

Status

Completed

Conditions

Simvastatin
Autogenous Tooth Bone Graft
Immediate Implant Placement

Treatments

Procedure: immediate implant placement with ATBG and SMV
Procedure: immediate implant placement with ATBG

Study type

Interventional

Funder types

Other

Identifiers

NCT04992416
KFSIRB200-27

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

26 participants in 2 patient groups

SMV with ATBG around implant
Experimental group
Description:
SMV mixed with ATBG around immediately placed dental implants in the extraction sockets
Treatment:
Procedure: immediate implant placement with ATBG and SMV
ATBG around implant
Active Comparator group
Description:
ATBG around immediately placed dental implants in the extraction sockets
Treatment:
Procedure: immediate implant placement with ATBG

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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