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

NCT06323993 | Completed

• 1 other identifier: 2021-115
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Perforation incidence

  During the surgery

• Early implant loss

  6 months after surgery

• Lateral window length

  Immediately after surgery, and 6 months after surgery

• Lateral bone length

  Immediately after surgery, and 6 months after surgery

Study Arms (2)

Piezoelectric osteotomy

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

Procedure: Piezoelectric osteotomy

Round Bur

This group used round bur (control) to prepare the lateral window acceding maxillary sinus

Interventions

Piezoelectric osteotomy PROCEDURE

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.

Piezoelectric osteotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• (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).

Sponsors & Collaborators

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

Study Sites (1)

Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Implantology Department

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: March 21, 2024
• Study Start: March 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: June 15, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

CN (1)