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A Modified Sinus Floor Elevation Technique - a Pilot Study on 12 Patients

Primary Purpose

Maxillary Sinus, Atrophy

Status

Recruiting

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

sinus floor elevation

About this trial

This is an interventional treatment trial for Maxillary Sinus

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

residual bone height of 3-6mm
residual bone width of >4mm

Exclusion Criteria:

not treated periodontal disease
smoker (>5cig/day)
acute or chronic sinusitis

Sites / Locations

Bernhard Gottlieb School of Dentistry, Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sinus floor elevation

Arm Description

Outcomes

Primary Outcome Measures

Height of augmentation

Secondary Outcome Measures

Full Information

NCT ID

NCT02137824

First Posted

May 12, 2014

Last Updated

March 14, 2023

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT02137824

Brief Title

A Modified Sinus Floor Elevation Technique - a Pilot Study on 12 Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 2014 (undefined)

Primary Completion Date

December 2030 (Anticipated)

Study Completion Date

December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

5. Study Description

Brief Summary

The aim of the present study is to establish a modified minimally invasive surgical technique for sinus floor augmentation with a residual bone height of 3-6mm. Hypothesis: The investigators expect that the present surgical technique allows to achieve an adequate implant bed of at least 10mm height after a healing period of 3-5 months. Further the modification of the technique enables a reduced patient stress level.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Maxillary Sinus, Atrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sinus floor elevation

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

sinus floor elevation

Primary Outcome Measure Information:

Title

Height of augmentation

Time Frame

after 4-5months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: residual bone height of 3-6mm residual bone width of >4mm Exclusion Criteria: not treated periodontal disease smoker (>5cig/day) acute or chronic sinusitis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kristina Bertl, PD, DMD, MSc

kristina.bertl@meduniwien.ac.at

Facility Information:

Facility Name

Bernhard Gottlieb School of Dentistry, Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristina Bertl, PD, DMD, MSc

kristina.bertl@meduniwien.ac.at

First Name & Middle Initial & Last Name & Degree

Kristina Bertl, PD, DMD, MSc

12. IPD Sharing Statement

Learn more about this trial

A Modified Sinus Floor Elevation Technique - a Pilot Study on 12 Patients

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