NCT02741752

Brief Summary

The purpose of this randomized clinical trial was to evaluate the effect of cortical bone decortication on the angiogenesis and osteogenesis of augmented ridge by GBR.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

April 11, 2016

Last Update Submit

April 15, 2016

Conditions

Keywords

histomorphometry

Outcome Measures

Primary Outcomes (1)

  • The amount of vital bone formation by histomorphometric analysis after cortical bone perforation

    7 months

Study Arms (2)

test group

EXPERIMENTAL

decortication group

Procedure: Decortication

control

NO INTERVENTION

without decortication

Interventions

DecorticationPROCEDURE

cortical bone perforation

test group

Eligibility Criteria

Age25 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Cerebral Decortication

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, postgraduate resident

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 18, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 18, 2016

Record last verified: 2016-04