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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04992416
Other study ID # KFSIRB200-27
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2021
Est. completion date December 15, 2022

Study information

Verified date August 2023
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 15, 2022
Est. primary completion date December 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Egypt Faculty of Dentistry, Kafrelsheikh University Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary clinical evaluation of bone formation around immediately placed dental implants Changes on bone formation using ATBG with or without SMV around immediately placed dental implants in periodontally compromised teeth 9 months
Primary radiographic outcome around immediately placed dental implants the radiographic outcome of ATBG on bone formation with or without SMV around immediately placed dental implants in periodontally compromised teeth 9 months
See also
  Status Clinical Trial Phase
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Recruiting NCT05436158 - The Use of a New Safe Angle Position for Implant Placement in the Anterior Region.
Not yet recruiting NCT06246253 - Bone Formed Labial to the Implant in Relation to the Horizontal Gap Dimension in Immediate Implant Placement.
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Enrolling by invitation NCT05330702 - Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With or Without Soft Tissue Augmentation N/A
Enrolling by invitation NCT05880771 - Immediate Implant Placement: a Clinical and Radiographic Study on Hard and Soft Tissues Retraction at One Year. N/A
Completed NCT04795102 - Effect of "Autogenous Leukocyte Platelet Rich Fibrin- Tooth Graft" Combination Around Immediately Placed Implants N/A
Completed NCT03422458 - The Impact of Immediate Implant Placement on Alveolar Ridge Preservation Techniques N/A
Completed NCT04803500 - Simvastatin Around Immediate Implant Phase 2