NCT05362136

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

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

• Sinus Elevation
• Dental Implant
• Bone Formation

Interventions

Type	Name	Description
PROCEDURE	perforation of the sinus floor	perforation of the cortical layer of the sinus floor prior to inserting the augmentation material during sinus floor elevation
PROCEDURE	no perforation of the sinus floor	standard procedure for sinus floor elevation

Timeline

• Start date: 2017-03-23
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2022-05-05
• Last updated: 2022-05-11

Locations

1 site across 1 country: Austria