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

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Medical University of Vienna

Status

Enrolling

Conditions

Bone Formation
Sinus Elevation
Dental Implant

Treatments

Procedure: no perforation of the sinus floor
Procedure: perforation of the sinus floor

Study type

Interventional

Funder types

Other

Identifiers

NCT05362136
1709/2016

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 120 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

12 participants in 2 patient groups

Control
Active Comparator group
Description:
standard sinus floor elevation
Treatment:
Procedure: no perforation of the sinus floor
Test
Experimental group
Description:
standard sinus floor elevation with additional perforation of the sinus floor
Treatment:
Procedure: perforation of the sinus floor

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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