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

Not Applicable

Recruiting

• Conditions: Bone Formation; Dental Implant; Sinus Elevation
• Interventions: Procedure: no perforation of the sinus floor; Procedure: perforation of the sinus floor

• Registration Number: NCT05362136
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-23
• Status Verified: 2022-05
• Study First Submitted: 2022-05-01
• Study First Submitted QC: 2022-05-01
• Study First Posted: 2022-05-05
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-11
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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Exclusion Criteria

• uncontrolled periodontal disease
• acute or chronic sinusitis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	no perforation of the sinus floor	standard sinus floor elevation
Test	perforation of the sinus floor	standard sinus floor elevation with additional perforation of the sinus floor

Primary Outcome Measures

Name	Time	Method
New bone formation	4-6 months after sinus floor elevation	histological assessment of new bone formation after sinus floor elevation (%)

Trial Locations

Locations (1)

University Clinic of Dentistry, Medical University of Vienna; 🇦🇹 Vienna, Austria