Clinical, Patient-Reported outcomes and Efficacy of Static Computer-Assisted Sinus Floor Augmentation: A Randomized Controlled Trial.

Chulalongkorn University0 sites40 target enrollmentApril 27, 2023

ConditionsPatients who need for implant placement in posterior maxilla with residual alveolar bone height between 1-5 mm Surgical guide, Guided surgery, computer-assisted surgery, lateral window sinus floor elevation, sinus augmentation, patient-reported outcomes

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Patients who need for implant placement in posterior maxilla with residual alveolar bone height between 1-5 mm
Sponsor: Chulalongkorn University
Enrollment: 40
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

o statistically significant difference was found between the two groups with regards to PROMs and intra-, post-operative complications, apart from higher level of swelling for SCA-SFA patients on day 2 after surgery. The use of SCA-SFA significantly reduced the time needed to conduct the window osteotomy (SCA 1113.80 + 730.41 sec vs SCA-SFA 685.50 + 285.28 sec) and the total surgery duration (SCA 4193.30 + 1204.98 sec vs SCA-SFA 3374.35 + 960.45 sec).

Registry

who.int

Start Date

April 27, 2023

End Date

February 29, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Chulalongkorn University

Eligibility Criteria

Inclusion Criteria

•1\.Medically healthy adult (ASA I\-II) and age more than 21 years old
•2\.Non\-smoker or previous smoker (quit more than 5 years) or light smoker with less than 10 cigarettes/day
•3\.Edentulous spaces in posterior maxilla in 1 or 2 posterior quadrants with an alveolar bone defect which requires lateral approach sinus floor augmentation for 1\-3 implant placement (residual crestal height less than 6 mm)
•4\.Absence of sinus membrane pathology or rhinosinusitis or other pathology requiring management

Exclusion Criteria

•1\. Medically compromised subjects (ASA III\-V)
•2\.General contraindications against implant treatment or augmentative procedures
•(immunodeficiency or advanced systemic diseases or corticosteroid medication)
•3\.Patients taking oral bisphosphonates longer than 5 years /anti\-angiogenic/RANKL inhibitor medications or receiving local radiotherapy
•4\.Heavy smoker or previous heavy smoker (quit less than 5 years or more than 10 cigarettes/day)
•5\.Acute/Chronic unmanaged symptomatic sinusitis
•6\.Type 1 implant placement (immediate implant placement following extraction)
•7\.Need for simultaneous soft tissue augmentation.
•8\.Residual bone height more than 6 mm
•9\.Subjects aged less than 21 years old