NCT03734094

Brief Summary

It is a comparative study between custom-made ceramic barrier and titanium mesh for augmentation of atrophic posterior mandible.

Trial Health

87
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 Jul 2018

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

July 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

Same day

First QC Date

November 1, 2018

Last Update Submit

December 19, 2018

Conditions

Bone Loss

Outcome Measures

Primary Outcomes (2)

  • Bone height

    CBCT \& Three dimensional planning software to measure the height of bone gained in millimeters.

    6 months

  • Bone width

    CBCT \& Three dimensional planning software to measure the width of bone gained in millimeters.

    6 months

Secondary Outcomes (1)

  • Histomorphometric - bone area percent

    6 months

Study Arms (2)

Ceramic Barrier

EXPERIMENTAL

The use of a ceramic barrier to induce bone formation during GBR

Device: Titanium Mesh

Titanium mesh

ACTIVE COMPARATOR

The use of a titanium mesh to induce bone formation during GBR

Device: Ceramic barrier

Interventions

Ceramic barrierDEVICE

The use of a ceramic barrier to induce bone formation during GBR

Titanium mesh
Titanium MeshDEVICE

The use of a titanium mesh to induce bone formation during GBR

Ceramic Barrier

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with atrophic posterior mandible
  • Both sexes
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement

You may not qualify if:

  • Untreated gingivitis
  • Periodontitis
  • Insufficient oral hygiene
  • Previous radiation therapy
  • Head and neck neoplasia
  • Systemic disorders
  • Heavy smokers
  • Bone pathology
  • Psychiatric problems
  • Emotional instability
  • Unrealistic aesthetic demands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12611, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 7, 2018

Study Start

July 1, 2018

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

December 21, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will share

Locations

EG(1)