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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Implantation; Surgical Procedure, Unspecified; Maxillary Sinus Floor Augmentation; Cone-Beam Computed Tomography
• Intervention / Treatment: Procedure: Piezoelectric osteotomy

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Consecutive subjects were selected among patients who have received LSFE with graft materials with simultaneous implant placement from November 2018 to June 2021 in the Department of Implantology at the Affiliated Hospital of Stomatology, Zhejiang University School of Medicine, China.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Piezoelectric osteotomy; This group used piezoelectric osteotomy (exposure) to prepare the lateral window acceding maxillary sinus	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.
Round Bur; This group used round bur (control) to prepare the lateral window acceding maxillary sinus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Augmentation volume	The volume of the endo-sinus reconstructed graft materials	Immediately after surgery, and 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perforation incidence	Sinus perforation was determined by direct visualization and the Valsalva maneuver during the surgery process.	During the surgery
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
Lateral window length	the distance between the edges of lateral window caused by the lateral antrostomy	Immediately after surgery, and 6 months after surgery
Lateral bone length	the length of the bone window ob- tained by piezoelectric osteotomy	Immediately after surgery, and 6 months after surgery

Collaborators and Investigators

• Sponsor: The Dental Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: September 3, 2023
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2021-115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No