NCT02137824

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
56mo left

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
May 2014Dec 2030

Study Start

First participant enrolled

May 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
16.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

16.6 years

First QC Date

May 12, 2014

Last Update Submit

March 14, 2023

Conditions

Maxillary SinusAtrophy

Outcome Measures

Primary Outcomes (1)

  • Height of augmentation

    after 4-5months

Study Arms (1)

sinus floor elevation

EXPERIMENTAL
Procedure: sinus floor elevation

Interventions

sinus floor elevationPROCEDURE
sinus floor elevation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bernhard Gottlieb School of Dentistry, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Atrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Kristina Bertl, PD, DMD, MSc

CONTACT

kristina.bertl@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD, DMD, MSc

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 14, 2014

Study Start

May 1, 2014

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations

AU(1)