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

Completed

• Conditions: Dental Implantation; Cone-Beam Computed Tomography; Maxillary Sinus Floor Augmentation; Surgical Procedure, Unspecified
• Interventions: Procedure: Piezoelectric osteotomy

• Registration Number: NCT06323993
• Lead Sponsor: The Dental Hospital of Zhejiang University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-05-01
• Study Completion: 2023-06-15
• Study First Submitted: 2023-09-03
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Piezoelectric osteotomy	Piezoelectric osteotomy	This group used piezoelectric osteotomy (exposure) to prepare the lateral window acceding maxillary sinus

Primary Outcome Measures

Name	Time	Method
Apical bone height	Immediately after surgery, and 6 months after surgery	The distance (mm) from the implant apex to the most apical position of the graft material along the longitudinal axis of the implant
Endo-sinus bone gain	Immediately after surgery, and 6 months after surgery	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
Buccal bone height	Immediately after surgery, and 6 months after surgery	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
Palatal bone height	Immediately after surgery, and 6 months after surgery	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
Augmentation volume	Immediately after surgery, and 6 months after surgery	The volume of the endo-sinus reconstructed graft materials

Secondary Outcome Measures

Name	Time	Method
Lateral bone length	Immediately after surgery, and 6 months after surgery	the length of the bone window ob- tained by piezoelectric osteotomy
Early implant loss	6 months after surgery	Early implant loss was defined as an implant show- ing clinical mobility prior to the placement of the abutment
Perforation incidence	During the surgery	Sinus perforation was determined by direct visualization and the Valsalva maneuver during the surgery process.
Lateral window length	Immediately after surgery, and 6 months after surgery	the distance between the edges of lateral window caused by the lateral antrostomy

Trial Locations

Locations (1)

Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China