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

Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05362136
• Other study ID #: 1709/2016
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2017
• Est. completion date: December 2027

Study information

• Verified date: May 2022
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant

Intervention

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
• no perforation of the sinus floor
standard procedure for sinus floor elevation

Locations

Country	Name	City	State
Austria	University Clinic of Dentistry, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New bone formation	histological assessment of new bone formation after sinus floor elevation (%)	4-6 months after sinus floor elevation