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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Piezoelectric osteotomy
The piezoelectric technique, another window preparation procedure that does not use a round bur, was first introduced to LSFE in 2001 for its high accuracy of osteotomy and low rate of membrane perforation. Later studies demonstrated that the operation time, postoperative reactions, and perforation rate of this procedure are considered to be acceptable compared with rotary bur. Moreover, the piezoelectric technique allows for the lateral bone window to be cut and preserved relatively completely.

Locations

Country Name City State
China Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
The Dental Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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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