Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure

November 9, 2023 updated by: Ahmed Zewail

Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure With Simultaneous Implant Placement

The purpose of this study is to present a guided lateral window sinus lift (GLSL) procedure with the aid of a fully digital workflow using surgical templates for window osteotomy preparation and implant placement.

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

In Group 1; The surgical procedure began with the adaptation of a prefabricated guide to the surgical site, ensuring firm stabilization. Implant positions were marked, and after the removal of the guide, a crestal incision was made. A mucoperiosteal flap was reflected, exposing the maxillary sinus and alveolar crest. The guide was readapted, marking implant positions, and a lateral window was formed using a bur or piezotome. Sinus membrane elevation was performed carefully. Implants were placed with graft material beneath the elevated membrane. In cases of bony plate preservation, the window was covered. In Group 2 (Lateral Maxillary Sinus Floor Elevation without a surgical guide), a crestal incision and mucoperiosteal flap exposed the sinus. A bony window was created, and careful elevation of the sinus floor followed. Implant osteotomies were completed, and graft material was packed into the sinus. A resorbable membrane was applied, and the flap was sutured. NanoboneÒ was used as the standard graft material in both groups.

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.
14

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

  • Egypt
      • Assuit, Egypt
        • Faculty of Dental 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

Description

Inclusion Criteria:

  • Healthy adult patients (over 18 years of age), without any systemic complication.
  • Patients who need for dental implant in posterior maxilla with bone height below the maxillary sinus is < 6 mm.
  • Non smokers or patients who smoked less than 11 cig/day Will be included.

Exclusion Criteria:

  • Uncontrolled systemic diseases which affect bone healing.
  • Presence of any pathology in the site of operation.

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: Double

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: Group 1: Lateral Maxillary Sinus Floor Elevation using surgical guide
Procedure: Lateral Maxillary Sinus Floor Elevation using surgical guide
The surgical procedure begins with securing a prefabricated guide firmly to the surgical site. Implant positions are marked, and after guide removal, a crestal incision is made 1 mm palatal to the marked point, extending with sulcular and vertical incisions. A full-thickness mucoperiosteal flap is reflected to expose the maxillary sinus and alveolar crest. After readapting the surgical guide to the bone, implant positions are marked, and cutting edges are tracked. The lateral window is formed by extending and connecting mesial and distal borders, created using piezotome. The sinus membrane is carefully reflected and elevated with a surgical curette to avoid iatrogenic perforation. Implant fixtures are then placed using the identical surgical guide, followed by graft material placement beneath the elevated sinus membrane. If the bony plate is preserved, the lateral window is covered with the plate.
Active Comparator: Group 2: Lateral Maxillary Sinus Floor Elevation without surgical guide
Procedure: Lateral Maxillary Sinus Floor Elevation without surgical guide
The sinus's lateral wall is exposed through a crestal incision and a mucoperiosteal flap. A bony window is created, and upon its removability, the sinus floor is carefully elevated using sinus elevation curettes, taking care to avoid membrane perforation. In cases of perforation, a resorbable collagen membrane is applied to cover the hole. Implant osteotomies are then completed following the standard sequential placement protocol. Graft material, mixed with normal saline, is gently packed into the sinus to fill the cavity with bone substitute material and achieve the desired bone height. Finally, a resorbable membrane is placed on the outer surface of the window, and the flap is sutured for primary closure.

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
Maxillary sinus volume
Time Frame: Preoperative, Immediate postoperative, 6 Months
In cubic centimetre (cm3)
Preoperative, Immediate postoperative, 6 Months

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
Bone Gain
Time Frame: Immediate postoperative, 6 Months
Im Millimeter (mm)
Immediate postoperative, 6 Months
Implant stability
Time Frame: Intra-operative, 6 Months
In implant stability quotient (ISQ)
Intra-operative, 6 Months

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.
Ahmed Zewail

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.
December 29, 2020

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.
February 1, 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.
February 1, 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).
November 9, 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.
November 9, 2023

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.
November 14, 2023

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.
November 14, 2023

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.
November 9, 2023

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.
November 1, 2023

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.
  • AUAREC202100012-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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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