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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implant; Sinus Elevation; Bone Formation
• Intervention / Treatment: Procedure: no perforation of the sinus floor; Procedure: perforation of the sinus floor

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • University Clinic of Dentistry, Medical University of Vienna
    • Contact: Kristina Bertl; Email: kristina.bertl@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control; standard sinus floor elevation	Procedure: no perforation of the sinus floor; standard procedure for sinus floor elevation
EXPERIMENTAL: Test; standard sinus floor elevation with additional perforation of the sinus floor	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New bone formation	histological assessment of new bone formation after sinus floor elevation (%)	4-6 months after sinus floor elevation

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2017
• Primary Completion (ANTICIPATED): December 1, 2025
• Study Completion (ANTICIPATED): December 1, 2027

Study Registration Dates

• First Submitted: May 1, 2022
• First Submitted That Met QC Criteria: May 1, 2022
• First Posted (ACTUAL): May 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1709/2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No