NCT04992416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

September 2, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

August 1, 2021

Last Update Submit

August 29, 2023

Conditions

Autogenous Tooth Bone GraftImmediate Implant PlacementSimvastatin

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

SMV with ATBG around implant

EXPERIMENTAL

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

Procedure: immediate implant placement with ATBG and SMV

ATBG around implant

ACTIVE COMPARATOR

ATBG around immediately placed dental implants in the extraction sockets

Procedure: immediate implant placement with ATBG

Interventions

immediate implant placement with ATBG and SMVPROCEDURE

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

SMV with ATBG around implant
immediate implant placement with ATBGPROCEDURE

immediate implant placement using ATBG as a graft material without SMV

ATBG around implant

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, 33511, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 38467945DERIVED

Study Officials

  • Dalia R Issa, PhD

    Kafrelsheikh University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 1, 2021

First Posted

August 5, 2021

Study Start

September 2, 2021

Primary Completion

December 10, 2022

Study Completion

December 15, 2022

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations

EG(1)