Surgical Procedure, Unspecified Clinical Trial
Official title:
The Clinical Outcomes of Lateral Sinus Floor Elevation With Different Window Preparation Approaches: a Retrospective Study
NCT number | NCT06323993 |
Other study ID # | 2021-115 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2022 |
Est. completion date | June 15, 2023 |
Verified date | March 2024 |
Source | The Dental Hospital of Zhejiang University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study retrospectively evaluated the effect of two different lateral window preparation techniques on peri-implant bone augmentation for patients who underwent lateral sinus floor elevation with simultaneous implant placement using two-dimensional and three-dimensional radiographic results, with special emphasis placed on the stability of the graft material after surgery.
Status | Completed |
Enrollment | 34 |
Est. completion date | June 15, 2023 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age =18 years; - one or more maxillary posterior teeth were missing, and the healing time was more than 3 months; - complete basic information and detailed operation records; - available CBCT images before surgery, immediately after surgery, and 6 months after surgery; - RBH =6 mm shown by CBCT at T0 at the site of the missing tooth; - no systematic diseases and no untreated periapical disease or periodontal disease before surgery. Exclusion Criteria: - (1) maxillary lesions have not been properly treated; - present or past medication of bisphosphonates; - pregnancy or lactation; - present or past radiotherapy of head and neck cancer within 5 years; - acute and chronic inflammation in the maxillary sinus; - in need of additional vertical or horizontal bone augmentation besides LSFE with endo-sinus graft materials; - heavy smoker (>20 cigarettes/day at the time of surgery). |
Country | Name | City | State |
---|---|---|---|
China | Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
The Dental Hospital of Zhejiang University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Apical bone height | The distance (mm) from the implant apex to the most apical position of the graft material along the longitudinal axis of the implant | Immediately after surgery, and 6 months after surgery | |
Primary | Endo-sinus bone gain | The distance (mm) from the level of the sinus floor (middle of the buccal level and palatal level) to the level of the most apical position of the graft material along the longitudinal axis of the implant | Immediately after surgery, and 6 months after surgery | |
Primary | Palatal bone height | The vertical distance (mm) from the api- cal margin of the implant shoulder on the palatal side straight up to the position of the most apical position of the graft material | Immediately after surgery, and 6 months after surgery | |
Primary | Buccal bone height | The vertical distance (mm) from the api- cal margin of the implant shoulder on the buccal side straight up to the position of the most apical position of the graft material | Immediately after surgery, and 6 months after surgery | |
Primary | Augmentation volume | The volume of the endo-sinus reconstructed graft materials | Immediately after surgery, and 6 months after surgery | |
Secondary | Perforation incidence | Sinus perforation was determined by direct visualization and the Valsalva maneuver during the surgery process. | During the surgery | |
Secondary | Early implant loss | Early implant loss was defined as an implant show- ing clinical mobility prior to the placement of the abutment | 6 months after surgery | |
Secondary | Lateral window length | the distance between the edges of lateral window caused by the lateral antrostomy | Immediately after surgery, and 6 months after surgery | |
Secondary | Lateral bone length | the length of the bone window ob- tained by piezoelectric osteotomy | Immediately after surgery, and 6 months after surgery |
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