Maxillary Sinus Elevation and Perioperative Complications

September 14, 2024 updated by: Mehmet Melih Omezli, T.C. ORDU ÜNİVERSİTESİ

Comparison of Sinus Lifting Techniques Performed with Piezosurgery and a Surgical Guide, a Specially Designed Drill, and Conventional Drills in Terms Complications and Quality of Life

This study aims to investigate the effects of various external sinus lifting techniques on patient comfort and perioperative complications.

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.

Detailed Description

Patients who met the inclusion criteria and were admitted for posterior maxilla rehabilitation participated in this prospective, randomized, controlled clinical trial. The three methods used to lift the sinuses were randomized: piezosurgery using a surgical guide, a drill specifically made for lateral sinus lift, and traditional drills. Recorded were the duration of the procedure, accessibility, and intraoperative complications. During the first week following surgery, analgesic intake and pain using a visual analog scale (VAS) were assessed assessed. Preoperatively and on the second and seventh postoperative days, edema was assessed. Preoperatively and on the seventh postoperative day, the patient's quality of life using the OHIP-14 questionnaire, experiences, and expectations were evaluated.

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.
Interventional

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.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Turkey
    • Altınordu
      • Ordu, Altınordu, Turkey, 52200
        • Ordu university

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

No

Description

Inclusion Criteria:

  1. Severe resorption or sinus pneumatization in the posterior maxilla that prevents standard implant treatment; class V or VI according to Cawood and Howell classification, patients with residual bone height less than 6 mm
  2. Patients over 18 years of age
  3. Patients without a history of reconstructive pre-prosthetic surgery or previous implant surgery
  4. Patients with partial edentulism who have applied to our center for implant treatment and need sinus lifting
  5. Patients with cone beam computed tomography (CBCT) taken within the last 1 month

Exclusion Criteria:

  1. Patients with a history of systemic diseases (hematologic, neurologic, etc.) that may be contraindicated surgery
  2. Patients who are pregnant or in lactation period
  3. Patients with a history of immune system disorders and substance abuse
  4. Patients with a history of radiotherapy in the head and neck region
  5. Patients with existing maxillary sinus pathology or who have undergone surgery
  6. Patients who smoke >10 cigarettes per day
  7. Patients using antibiotics or steroids in the 30 days before surgery
  8. Uncooperative patients who do not comply with the study protocol or follow-up regimen
  9. Patients with perforation of the Schneiderian membrane

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: Reamer Group
The group in which the lateral window was created with conventional rotary instrument burs
Procedure: maxillary sinus lift with reamer
Lateral window created with specially designed burs for lateral sinus lift
Active Comparator: Piezo surgery with Surgical Guide Group
The group in which the lateral window was created using piezo surgery and surgical guide
Procedure: maxillary sinus lift with piezzo
lateral window was created using piezo surgery and surgical guide
Active Comparator: Conventional Group
The group in which the lateral window was created with conventional rotary instrument burs
Procedure: maxillary sinus lift with conventional burr
the lateral window was created with conventional rotary instrument burs

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
Operation Time
Time Frame: from the osteotomy of the sinus window to completation of membrane elevation
The time from the osteotomy of the sinus window to completation of membrane elevation
from the osteotomy of the sinus window to completation of membrane elevation

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
Patient Experience
Time Frame: 7th postoperative day
Patients asked to rate their postoperative experience with a 3-point scale (0, my expectation and experience were the same/similar; 1, my experience was better than my expectation; 2, my experience was worse than my expectation)
7th postoperative day
Pain
Time Frame: from 6 hours to postoperative 7 days
intensity of pain experienced by patients assessed using a 10-cm Visual Analogue Scale (VAS)
from 6 hours to postoperative 7 days
Analgesic Consumption
Time Frame: from 6 hours to 7 days postoperatively
need for analgesics
from 6 hours to 7 days postoperatively
Edema
Time Frame: on the 2nd and 7th days
Swelling after surgery measurements collected of a anatomical locations on the face that served as reference points. Reference points included the tragus, alare, lateral corner of the eye, gonion, soft tissue pogonion, and external corner of the mouth. The average of each measurement was used to calculate the edema level.
on the 2nd and 7th days
Quality of Life
Time Frame: preoperatively and on postoperative day 7
The OHIP-14 used to measure quality of life. Scores ranged from 0 (no impact) to 56 (all oral health concerns encountered extremely frequently). It was scored as follows: Never (0 points); Seldom (1 point); Sometimes (2 points); Frequently (3 points); and Very frequently (4 points).
preoperatively and on postoperative day 7
Surgeon;s Comfort
Time Frame: Immediately after surgery
The comfort of the access to the operation site evaluated by the surgeon on a 4-point scale (0, very poor visibility; 1, fair visibility; 2, good visibility; 3, excellent visibility)
Immediately 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.
T.C. ORDU ÜNİVERSİTESİ

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.
June 12, 2023

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.
December 14, 2023

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.
December 14, 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 10, 2024

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.
September 14, 2024

First Posted (Estimated)

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.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
September 19, 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.
September 14, 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.
September 1, 2024

More Information

Terms related to this study

Keywords

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.
  • B-2323
  • 23-AKD-48 (Other Identifier: Turkish Medicines and Medical Devices Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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