Actively Recruiting

Phase Not Applicable
Age: 18Years - 120Years
All Genders
Healthy Volunteers
NCT05362136

Effect of Multiple Perforations of the Sinus Floor on Bone Formation After Sinus Floor Elevation

Led by Medical University of Vienna · Updated on 2022-05-11

12

Participants Needed

1

Research Sites

557 weeks

Total Duration

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AI-Summary

What this Trial Is About

The aim of the present study is to compare the rate of new bone formation after sinus floor elevation with or without perforation of the cortical sinus floor prior to insertion of augmentation material. Twelve patients requiring bilateral sinus floor elevation will be recruited for a pilot study in split-mouth design. On both sides a lateral window will be prepared and the sinus mucosa will be elevated. After this step, the sides are assigned as test or control side. While the control side is just filled with augmentation material, an additional step is performed for the test side, i.e., prior to inserting the augmentation material, the cortical bone layer of the sinus floor is perforated several times into the trabecular bone layer to improve the blood supply to the grafting material. Thereafter, both sides are left to healing for 4-6 months until implant installation. At timepoint of implant installation, a bone biopsy will be collected to allow histological assessment of the grafted area.

CONDITIONS

Official Title

Effect of Multiple Perforations of the Sinus Floor on Bone Formation After Sinus Floor Elevation

Who Can Participate

Age: 18Years - 120Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Need for bilateral sinus floor elevation
  • Residual alveolar ridge height between 2 and 6 millimeters
  • Residual alveolar ridge width greater than 4 millimeters
Not Eligible

You will not qualify if you...

  • Uncontrolled periodontal disease
  • Acute or chronic sinusitis

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Clinic of Dentistry, Medical University of Vienna

Vienna, Austria, 1090

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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