The Effect of Different Window-preparation Approaches on the Clinical Outcomes of Lateral Sinus Floor Elevation

Surgical Procedure, Unspecified Clinical Trial

Official title:

The Clinical Outcomes of Lateral Sinus Floor Elevation With Different Window Preparation Approaches: a Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06323993
• Other study ID #: 2021-115
• Status: Completed
• 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
• 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).

Related Conditions & MeSH terms

• Cone-Beam Computed Tomography
• Dental Implantation
• Maxillary Sinus Floor Augmentation
• Surgical Procedure, Unspecified

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