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

Sponsor
Kafrelsheikh University (Other)
Overall Status
Completed
CT.gov ID
NCT04992416
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
17.4
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: immediate implant placement with ATBG and SMV
  • Procedure: immediate implant placement with ATBG
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites: A Randomized Controlled Clinical Trial
Actual Study Start Date :
Jul 2, 2020
Actual Primary Completion Date :
Dec 10, 2021
Actual Study Completion Date :
Dec 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: SMV with ATBG around implant

SMV mixed with ATBG around immediately placed dental implants in the extraction sockets

Procedure: immediate implant placement with ATBG and SMV
immediate implant placement using ATBG as a graft material, with SMV
Active Comparator: ATBG around implant

ATBG around immediately placed dental implants in the extraction sockets

Procedure: immediate implant placement with ATBG
immediate implant placement using ATBG as a graft material without SMV

Outcome Measures

Primary Outcome Measures

  1. clinical evaluation of bone formation around immediately placed dental implants [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 [9 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Kafrelsheikh University Kafr Ash Shaykh Egypt 33511

Sponsors and Collaborators

  • Kafrelsheikh University

Investigators

  • Principal Investigator: Dalia R Issa, PhD, Kafrelsheikh University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dalia Rasheed Issa, Principle investigator, Kafrelsheikh University
ClinicalTrials.gov Identifier:
NCT04992416
Other Study ID Numbers:
  • KD/18/20
First Posted:
Aug 5, 2021
Last Update Posted:
Apr 4, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 4, 2022