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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05362136

Enrollment

Registered

2022-05-05

Start date

2017-03-23

Completion date

2027-12-31

Last updated

2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Formation, Dental Implant, Sinus Elevation

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.

Interventions

PROCEDUREperforation of the sinus floor

perforation of the cortical layer of the sinus floor prior to inserting the augmentation material during sinus floor elevation

PROCEDUREno perforation of the sinus floor

standard procedure for sinus floor elevation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

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

Design outcomes

Primary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026