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

March 15, 2024 updated by: Guoli Yang, The Dental Hospital of Zhejiang University School of Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Immediately after surgery, and 6 months after surgery
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
Immediately after surgery, and 6 months after surgery
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
Immediately after surgery, and 6 months after surgery
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
Immediately after surgery, and 6 months after surgery
Augmentation volume
Time Frame: Immediately after surgery, and 6 months after surgery
The volume of the endo-sinus reconstructed graft materials
Immediately after surgery, and 6 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perforation incidence
Time Frame: During the surgery
Sinus perforation was determined by direct visualization and the Valsalva maneuver during the surgery process.
During the surgery
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
6 months after surgery
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
Immediately after surgery, and 6 months after surgery
Lateral bone length
Time Frame: Immediately after surgery, and 6 months after surgery
the length of the bone window ob- tained by piezoelectric osteotomy
Immediately after surgery, and 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Dental Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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