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

NCT ID: NCT04992416

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-02

Study Completion Date

2022-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Autogenous Tooth Bone Graft Immediate Implant Placement Simvastatin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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SMV with ATBG around implant

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

Group Type EXPERIMENTAL

immediate implant placement with ATBG and SMV

Intervention Type PROCEDURE

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

ATBG around implant

ATBG around immediately placed dental implants in the extraction sockets

Group Type ACTIVE_COMPARATOR

immediate implant placement with ATBG

Intervention Type PROCEDURE

immediate implant placement using ATBG as a graft material without SMV

Interventions

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immediate implant placement with ATBG and SMV

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

Intervention Type PROCEDURE

immediate implant placement with ATBG

immediate implant placement using ATBG as a graft material without SMV

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Dalia Rasheed Issa

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalia R Issa, PhD

Role: PRINCIPAL_INVESTIGATOR

Kafrelsheikh University

Locations

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Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, , Egypt

Site Status

Countries

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Egypt

References

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Issa DR, Nassar M, Elamrousy W. Immediately placed implants using simvastatin and autogenous tooth graft combination in periodontally compromised sites: a randomized controlled clinical trial. Clin Oral Investig. 2024 Mar 12;28(4):210. doi: 10.1007/s00784-024-05596-4.

Reference Type DERIVED
PMID: 38467945 (View on PubMed)

Other Identifiers

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KFSIRB200-27

Identifier Type: -

Identifier Source: org_study_id

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