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NCT Number: NCT07045389

Influence of the Sinus Floor-to-lower Window Margin Distance on Outcomes of Bone Window Repositioning in Lateral Sinus Floor Elevation With Simultaneous Implant Placement

The goal of this observational study is to evaluate how the vertical distance from the sinus floor to the lower margin of the lateral window affects bone regeneration and implant outcomes after lateral sinus floor elevation with simultaneous implant placement. The main question it aims to answer is:

Does a sinus floor-to-window margin distance ≥3 mm lead to better bone augmentation and implant stability compared to a distance <3 mm?

This is a retrospective, single-center cohort study. Participants included patients who had previously undergone lateral sinus floor elevation with implant placement and had at least 6 months of postoperative follow-up. Cone-beam CT images were used to measure radiographic outcomes such as alveolar bone height and augmented volume.

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Key information

Conditions

Sinus Floor Elevation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Hospital, School of Stomatology, Zhejiang University.

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Received lateral sinus floor elevation with bone window repositioning and simultaneous implant placement (LSFE with BWR and SIP) between 2019 and 2024
  • No contraindications to implantation
  • Complete medical and radiographic records available

Exclusion criteria

  • Uncontrolled systemic diseases
  • Incomplete medical or surgical records
  • Missing preoperative or postoperative imaging data

Treatment and study plan

Primary outcomes

  1. ABH at T1, ABH at T2, ABH change from T1 to T2, ESBG at T1, ESBG at T2, ESBG change from T1 to T2, BBH at T1, BBH at T2, BBH change from T1 to T2, PBH at T1, PBH at T2, PBH change from T1 to T2, AV at T1, AV at T2, AV change from T1 to T2

    Time frame: T1 (immediately after surgery) and T2 (6 months after surgery)

    ABH at T1 (mm): Alveolar bone height measured immediately after surgery; ABH at T2 (mm): ABH measured 6 months after surgery; ABH change from T1 to T2 (%): ABH Calculated as ((T2 - T1) / T1) × 100%; ESBG at T1 (mm): Elevated sinus bone gain measured immediately after surgery; ESBG at T2 (mm): ESBG measured 6 months after surgery; ESBG change from T1 to T2 (%): ESBG Calculated as ((T2 - T1) / T1) × 100%; BBH at T1 (mm): Buccal bone height measured immediately after surgery; BBH at T2 (mm): BBH measured 6 months after surgery; BBH change from T1 to T2 (%): BBH Calculated as ((T2 - T1) / T1) × 100%; PBH at T1 (mm): Palatal bone height measured immediately after surgery; PBH at T2 (mm): PBH measured 6 months after surgery; PBH change from T1 to T2 (%): PBH Calculated as ((T2 - T1) / T1) × 100%; AV at T1 (mm³): Augmented volume measured immediately after surgery; AV at T1(mm³): AV measured 6 months after surgery; AV change from T1 to T2 (%): AV Calculated as ((T2 - T1) / T1) × 100%

Sponsors and collaborators

Lead sponsor

Guoli Yang

Other

Collaborators

  • National Natural Science Foundation of China
  • The Dental Hospital of Zhejiang University School of Medicine

Registry information

Official study title

Influence of the Sinus Floor-to-lower Window Margin Distance on Outcomes of Bone Window Repositioning in Lateral Sinus Floor Elevation With Simultaneous Implant Placement: A Retrospective Study

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

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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