NCT03663439

Brief Summary

Amount of bone volume and (width and height): Will be measured using linear measurements from CBCT after 6 month from implant insertion. Will be measured using Histometric analysis of bone area percent sampling from recipient site after 6 months.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

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

September 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

September 16, 2018

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2019

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

4 days

First QC Date

September 5, 2018

Last Update Submit

September 6, 2018

Conditions

Implant Complication

Keywords

anterior augmentation,shell technique,onlay bone graft

Outcome Measures

Primary Outcomes (1)

  • Histomorphometric

    Type of bone formed by graft, after 3 months biopsy from the bone formed

    3 months

Study Arms (2)

modified shell technique

EXPERIMENTAL

block of bone from the mandibular ramus divided into two shells ,grafting one shell in the anterior maxilla to increase width

Procedure: modified shell technique

onlay bone graft

ACTIVE COMPARATOR

grafting block of bone from the mandibular ramus in the atrophic anterior maxilla

Procedure: modified shell technique

Interventions

modified shell techniquePROCEDURE

divided block of bone into two shells and grafting one shell in anterior maxilla

modified shell techniqueonlay bone graft

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with atrophic anterior maxilla
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement
  • Both sexes.

You may not qualify if:

  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems
  • Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
control group (modified shell technique) study group (onlay bone graft)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: control group (modified shell technique) study group (onlay bone graft)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 10, 2018

Study Start

September 16, 2018

Primary Completion

September 20, 2018

Study Completion

February 16, 2019

Last Updated

September 10, 2018

Record last verified: 2018-09