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NCT Number: NCT05362136

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic of Dentistry, Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Kristina Bertl

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • in need of bilateral sinus floor elevation
  • residual alveolar ridge height 2-6mm
  • residual alveolar ridge width > 4mm

Exclusion criteria

  • uncontrolled periodontal disease
  • acute or chronic sinusitis

Treatment and study plan

perforation of the sinus floor

Procedure

perforation of the cortical layer of the sinus floor prior to inserting the augmentation material during sinus floor elevation

no perforation of the sinus floor

Procedure

standard procedure for sinus floor elevation

Primary outcomes

  1. New bone formation

    Time frame: 4-6 months after sinus floor elevation

    histological assessment of new bone formation after sinus floor elevation (%)

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Assessment of the Effect of Sinus Floor Perforation During Sinus Floor Elevation on Bone Formation Within the Augmentation Material

Important dates

Study start
2017
Primary completion
2025
Study completion
2027
First posted
May 5, 2022
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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