NCT02117882

Brief Summary

It is assumed that the minimally invasive lateral approach and the traditional lateral sinus lift procedure will result in better outcomes in terms of height of augmented bone. It is also assumed that the minimally invasive lateral approach will reduce surgical complications and patient's discomfort in comparison with a traditional lateral sinus lift procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

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

January 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

1.2 years

First QC Date

April 16, 2014

Last Update Submit

April 16, 2014

Conditions

Bone Involvement in Diseases Classified Elsewhere

Keywords

lateral approach, bone augmentation , sinus floor elevation

Outcome Measures

Primary Outcomes (1)

  • height of augmented bone

    6 months

Secondary Outcomes (1)

  • post surgical patient's discomfort

    2 weeks

Study Arms (2)

minimally invasive approach test

minimally invasive lateral approach

control lateral traditional approach

standard surgical approach

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

15 patients edentulous in maxillary posterior area have been treated with a bilateral sinus lift procedure.

You may qualify if:

  • \- patient edentulous in the maxillary posterior area on both left and right side( not completely edentulous).
  • \- residual bone height in the maxillary premolar and molar region less than 4mm.

You may not qualify if:

  • \- history of systemic diseases that would contraindicate surgical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siena University, Department of Periodontology, Policlinico Le Scotte Siena.

Siena, Siena, 53100, Italy

Location

Study Officials

  • nicola nb baldini, oral surgeon

    tuscan school of dental medicine of florence and siena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
oral surgeon

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

January 1, 2013

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

IT(1)