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NCT Number: NCT06323993

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

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.

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Key information

Conditions

DENTAL IMPLANTATION Cone-Beam Computed Tomography Maxillary Sinus Floor Augmentation Surgical Procedure, Unspecified

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Apical bone height

    Time frame: 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

  2. Endo-sinus bone gain

    Time frame: 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

  3. Palatal bone height

    Time frame: 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

  4. Buccal bone height

    Time frame: 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

  5. Augmentation volume

    Time frame: Immediately after surgery, and 6 months after surgery

    The volume of the endo-sinus reconstructed graft materials

Secondary outcomes

  1. Perforation incidence

    Time frame: During the surgery

    Sinus perforation was determined by direct visualization and the Valsalva maneuver during the surgery process.

  2. Early implant loss

    Time frame: 6 months after surgery

    Early implant loss was defined as an implant show- ing clinical mobility prior to the placement of the abutment

  3. Lateral window length

    Time frame: Immediately after surgery, and 6 months after surgery

    the distance between the edges of lateral window caused by the lateral antrostomy

  4. Lateral bone length

    Time frame: Immediately after surgery, and 6 months after surgery

    the length of the bone window ob- tained by piezoelectric osteotomy

Sponsors and collaborators

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 21, 2024
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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