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

NCT05362136 | Recruiting

• 1 other identifier: 1709/2016
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinus Elevation; Dental Implant; Bone Formation

Outcome Measures

Primary Outcomes (1)

• New bone formation

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

  4-6 months after sinus floor elevation

Study Arms (2)

Control

ACTIVE COMPARATOR

standard sinus floor elevation

Procedure: no perforation of the sinus floor

Test

EXPERIMENTAL

standard sinus floor elevation with additional perforation of the sinus floor

Procedure: perforation of the sinus floor

Interventions

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

Test

no perforation of the sinus floor PROCEDURE

standard procedure for sinus floor elevation

Control

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• uncontrolled periodontal disease
• acute or chronic sinusitis

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

University Clinic of Dentistry, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: May 5, 2022
• Study Start: March 23, 2017
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

AU (1)