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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05362136
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 128.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sinus Elevation; Dental Implant; Bone Formation	Procedure: perforation of the sinus floor; Procedure: no perforation of the sinus floor	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Assessment of the Effect of Sinus Floor Perforation During Sinus Floor Elevation on Bone Formation Within the Augmentation Material
• Actual Study Start Date: Mar 23, 2017
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. New bone formation [4-6 months after sinus floor elevation]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Clinic of Dentistry, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kristina Bertl, Principal Investigator, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT05362136
• Other Study ID Numbers: 1709/2016
• First Posted: May 5, 2022
• Last Update Posted: May 11, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 11, 2022