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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06063980
Other study ID # VNUMed
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2, 2019
Est. completion date May 1, 2023

Study information

Verified date October 2023
Source VNU University of Medicine and Pharmacy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sinus floor elevation (SFA) and GBR have been applied in the placement of dental implants in longstanding edentate posterior maxilla region. However, the number of study on the efficacy of these procedure on areas with 0mm bone height is limited. This case study aims to compare two cases of 0mm bone height in the posterior maxillae region with different handling procedure. In this article, two female patients in their 40s underwent maxillary sinus augmentation (sinus lifting) due to longstanding missing posterior maxillary molars with the bone of which area had resorbed entirely, leaving 0mm bone height. One patient went through conventional sinus augmentation while the other had a two-stage - sinus - lift procedure. Researchers compared the bone - volume induced between the two procedures.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date May 1, 2023
Est. primary completion date September 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 45 Years
Eligibility Inclusion Criteria: - 0mm bone height at posterior maxillae region Exclusion Criteria: - general contraindication to implant surgery - subjected to irradiation in the head and neck area <1 one year before implantation - uncontrolled diabetes - pregnant or nursing - substance abuse - heavy smoker - psychiatric therapy or unrealistic expectations - immunosuppressed or immunocompromised - treated or under treatment with oral or intravenous aminobisphosphonates - untreated periodontitis - poor oral hygiene and motivation

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Conventional sinus lift surgery
After graft reflection, sinus membrane is separated from bone or oral mucosa and then bone graft is inserted in between the two structures.
Two-stage-sinus-lift procedure
Procedure is performed in two stages with the purpose of stage one to separate the oral mucosa from the sinus membrane using a small amount of bone graft and stage two as actual sinus augmentation, which is performed similar to that of conventional sinus lift procedure.

Locations

Country Name City State
Vietnam VNU University of Medicine and Pharmacy Hanoi

Sponsors (1)

Lead Sponsor Collaborator
VNU University of Medicine and Pharmacy

Country where clinical trial is conducted

Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bone formation recorded after two-step-sinus-augmentation. 9,98mm bone height is recorded on CBCT. 21 months
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