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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04992416
Enrollment
26
Registered
2021-08-05
Start date
2021-09-02
Completion date
2022-12-15
Last updated
2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autogenous Tooth Bone Graft, Immediate Implant Placement, Simvastatin

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.

Interventions

PROCEDUREimmediate implant placement with ATBG and SMV

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

immediate implant placement using ATBG as a graft material without SMV

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
clinical evaluation of bone formation around immediately placed dental implants9 monthsChanges on bone formation using ATBG with or without SMV around immediately placed dental implants in periodontally compromised teeth
radiographic outcome around immediately placed dental implants9 monthsthe radiographic outcome of ATBG on bone formation with or without SMV around immediately placed dental implants in periodontally compromised teeth

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026