NCT04049435

Brief Summary

The horizontal deficient anterior maxilla less than 3mm presents considerable challenges for surgical and prosthetic reconstruction. caused by trauma , infection, congenitally missing teeth or resorption subsequent to dental extractions hampers dental implant placement(Aghaloo \& Moy, 2007)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 2, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

August 2, 2019

Last Update Submit

August 25, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Horizontal bone gain

    Distanc buccolingually

    after 6 months

Secondary Outcomes (1)

  • Gained bone quality measured by histomorphomerty examination of core biopsy

    after 6 months

Study Arms (1)

horizontal deficiency anterior maxilla

Using the titanium sheet in augmentation of horizontally deficient anterior maxilla will be efficient, time saving, accurate reconstruction

Device: Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla

Interventions

Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla

horizontal deficiency anterior maxilla

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Case series

You may qualify if:

  • Horizontal deficient anterior maxilla \< 3mm.
  • All ages \>18 years

You may not qualify if:

  • \- 1. Patients systemic disease or immunocomprmized status that may affect normal healing of bone, and predictable outcome.
  • \. Patients with history of previous grafting procedure 3. Patients with physical and psychological intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdelwakeel

Giza, 002, Egypt

Location

Related Publications (1)

  • Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70.

Study Officials

  • Abdelwakeel Mohammed

    Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla (Case series study ).

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 8, 2019

Study Start

September 25, 2019

Primary Completion

October 31, 2020

Study Completion

October 1, 2021

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Undecided: It is not yet known if there will be a plan to make IPD available.

Shared Documents
STUDY PROTOCOL
Time Frame
2years
Access Criteria
This study will carried out on patients attending clinic of Master program for Oral Implantology - Faculty of Dentistry Cairo University.

Locations