NCT05020405

Brief Summary

Ridge split augmentation technique, with immediate implant placement, reduces the time of the treatment and the time of the final prosthetic reconstruction. Furthermore, compression of the bone increases its density. SMV is also found to promote osteogenic differentiation of bone marrow stem cells, suppress osteoclastic differentiation in bone tissue, and promotes osseointegration around implants in animal studies. The aim of this study is to compare surgical outcomes of the application of the alveolar ridge splitting (ARS) in combination with guided bone regeneration (GBR) using bone grafting and a barrier membrane, associated with immediate implant placement versus ARS in combination with the use of SMV with GBR using bone grafting and a barrier membrane, associated with immediate implant placement in patients with horizontally atrophic jaw bones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

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

Study Start

First participant enrolled

October 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2022

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

August 18, 2021

Last Update Submit

July 17, 2023

Conditions

Ridge SplittingSimvastatinImmediate Implant

Outcome Measures

Primary Outcomes (1)

  • Measurements of the amount of bone formation in millimeters around immediately placed dental implants

    Measurements of the amount of bone formation in millimeters using GBR with or without the combined effect of SMV in the ridge splitting following immediate implant placement.

    9 months

Study Arms (2)

ARS with GBR and SMV

EXPERIMENTAL

alveolar ridge splitting in combination with the use of GBR with SMV with immediate implant placement

Procedure: Immediate implant placement and ARS with GBR and SMV

alveolar ridge splitting with GBR

ACTIVE COMPARATOR

alveolar ridge splitting in combination with the use of GBR without SMV with immediate implant placement

Procedure: Immediate implant placement and ARS with GBR

Interventions

Immediate implant placement and ARS with GBR and SMVPROCEDURE

Implant insertion and GBR for augmentation of the gap between buccal and lingual plate using bone graft mixed with SMV

ARS with GBR and SMV
Immediate implant placement and ARS with GBRPROCEDURE

Implant insertion and GBR for augmentation of the gap between buccal and lingual plate

alveolar ridge splitting with GBR

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • good general health at the time of surgery.
  • at least 3 months of healing after tooth extraction.
  • horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.

You may not qualify if:

  • a vertical bone defect in the edentulous ridge.
  • thick cortex in the labial/buccal with less cancellous bone inside
  • obvious undercut on the labial/buccal side.
  • uncontrolled periodontal conditions or other oral disorders.
  • history of radiotherapy in the head and neck region.
  • uncontrolled diabetes mellitus or other systematic disorders.
  • smokers.
  • Pregnancy.
  • non-compliant patients.
  • allergic reaction to the medications used.

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, Elamrousy W, Gamal AY. Alveolar ridge splitting and simvastatin loaded xenograft for guided bone regeneration and simultaneous implant placement: randomized controlled clinical trial. Clin Oral Investig. 2024 Jan 4;28(1):71. doi: 10.1007/s00784-023-05427-y.

    PMID: 38172458DERIVED

MeSH Terms

Interventions

4-azido-2-nitrophenyluridylyl pyrophosphate

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 18, 2021

First Posted

August 25, 2021

Study Start

October 1, 2020

Primary Completion

February 12, 2022

Study Completion

February 20, 2022

Last Updated

July 18, 2023

Record last verified: 2023-07

Locations

EG(1)