SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW

November 3, 2023 updated by: Alex Nogueira Haas, Federal University of Rio Grande do Sul

COMPARISON OF IMPLANT INSTALLATION USING THE TRANSCRESTAL APPROACH WITH OSSEODENSIFICATION OR THE LATERAL WINDOW TECHNIQUE WITH SINUS LIFT: A RANDOMIZED CONTROLLED TRIAL.

This study will compare patient-reported outcomes, as well as the type and incidence of complications, and bone marginal loss after 12 months in implants installed using the transcrestal approach (tSFE) with an osseodensification system (performed according to the protocol by Huwais et al. 2018), or installed simultaneously using the lateral window technique (lSFE) with sinus lift. A blind, randomized, controlled clinical trial will be carried out with individuals over 18 years old, and with single tooth loss in the posterior maxilla, where the residual bone height (RBH) is 3 to 5 mm. The tSFE will be performed with osseodensification burs (Densa Bur, Versah, USA) using a counterclockwise motion, associated to synthetic biomaterial (hydroxyapatite and beta-tricalcium phosphate). The lSFE technique will require the sinus to be filled with the same biomaterial as the group using the other technique, and the antrostomy to be covered with a polydioxanone-based membrane. The patient's post-operatory perceptions will be evaluated by self-administered questionnaires quantifying social and professional isolation, physical appearance, duration and changes in quality of life, eating and speech, diet variations, and sleep deficiency for 2 weeks after the procedure. Pain will be assessed with the visual analogue scale (VAS). Immediately after prosthetic rehabilitation, cone beam tomography will be performed. Controls at 6 and 12 months will be performed. In these images, the marginal bone level in relation to a fixed reference point on the implants (upper part of the platform) will be measured mesially and distally in each implant, using a specific program (ImageJ - version 1.49v / NIH software - Bethesda, MD, USA). Generalized estimating equations will be used to compare the two treatments overtime. The significance level used will be 0.05.

Study Overview

Status

Status

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

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.
Interventional

Enrollment (Estimated)

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.
38

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

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90630080
        • Recruiting
        • Alex Haas
        • Contact:

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:

  • Maxillary sinuses that have residual bone height between at least 3 mm and 5 mm;
  • Width of the residual bone ridge that allows the insertion of an implant with a diameter of 4 mm;
  • Tomographic thickness of Schneider's membrane with a maximum of 5 mm in the region to be operated;
  • Residual ridge with ≥2 mm of medullary bone in the bucco-palatal direction, with a 1/1 ratio of medullary and cortical bone to achieve predictable plastic expansion;
  • Patients with adequate interarch space for placement of the prosthetic crown;
  • Good physical health status (ASA1 and ASA2, according to the Physical Status Classification System - American Society of Anesthesiologists);
  • At least 6 months since the last tooth loss in the region to be operated;

Exclusion Criteria:

  • - Those with sinus pathology;
  • Heavy smokers (more than 10 cigarettes a day);
  • Those with a history of head and neck radiotherapy;
  • Those who have already undergone bone augmentation in any of the targeted surgical areas;
  • Immunodeficiency of any nature;
  • Emotional instability and psychiatric problems;
  • Pregnancy;
  • Current use of oral bisphosphonates or history of using injectable bisphosphonate;
  • Patients with active periodontitis defined by the presence of subgingival bleeding greater than 10%;
  • Documented allergy to drugs or dental materials involved in the experimental protocol.

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.
Experimental: Osseodensification
Sinus floor elevation with osseodensification and concomitant implant installation
Procedure: Osseodensification with Versah system
Access to the bone crest will be performed through a slightly palatinized crestal incision, and a full-thickness mucoperiosteal flap will be elevated. Implant site preparation will be performed according to the bone densification drilling sequence established by the Densah® technique protocol
Active Comparator: Lateral window
Sinus floor elevation with lateral window and concomitant implant installation
Procedure: Lateral window
A full-thickness mucoperiosteal flap will be elevated. The lateral window will be made with a spherical diamond drill (number 8) at 20,000 rpm. The mesiodistal and apicocoronal dimensions of the lateral access window to the sinus will be measured in all the participants using a caliper. Sinus membrane elevation will be performed with manual instruments.

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
Pain level
Time Frame: baseline
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst imaginable pain"
baseline
Pain level
Time Frame: day 1
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
day 1
Pain level
Time Frame: day 2
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
day 2
Pain level
Time Frame: day 3
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
day 3
Pain level
Time Frame: day 4
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
day 4
Pain level
Time Frame: day 7
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
day 7
Pain level
Time Frame: day 14
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
day 14

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
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: baseline
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
baseline
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 1
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 1
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 2
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 2
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 3
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 3
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 4
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 4
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 5
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 5
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 6
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 6
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 7
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 7
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 8
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 8
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 9
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 9
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 10
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 10
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 11
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 11
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 12
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 12
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 13
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 13
Medication Diary (number of doses of Ibuprofen 600mg)
Time Frame: day 14
Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary
day 14

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Level of discomfort
Time Frame: as recorded on day 0 (night), +1, +2, +3, +4, +7, and +14,
Level of discomfort as recorded on a 5-point rating scale ranging from "no discomfort"; "little discomfort"; "discomfort"; "a lot of discomfort" and "very high discomfort"
as recorded on day 0 (night), +1, +2, +3, +4, +7, and +14,
Limitations in daily functions
Time Frame: as recorded on day 0 (night), +1, +2, +3, +4, +7 and + 14
Limitations in daily functions (i.e. swallowing, breathing, continuing daily activities, eating, speaking, opening the mouth), on a 5-point rating scale ranging from "no limitations" to "unable to eat all kinds of food" (for the item "eat"), and from "no difficulty" to "extreme difficulty" (for the other items );
as recorded on day 0 (night), +1, +2, +3, +4, +7 and + 14
Incidence of postoperative signs and symptoms
Time Frame: day 0 (night), +1, +2, +3, +4, +7 and +14;
Incidence of swelling, nausea, bruising, nasal discharge/bleeding, nasal stuffiness, bad taste/smell
day 0 (night), +1, +2, +3, +4, +7 and +14;
Willingness to undergo the same type of surgery
Time Frame: recorded on day +14
a 4-point rating scale ranging from "no problem to repeat surgery if needed" to "I will never have this type of surgery again."
recorded on day +14
Clinical Outcomes
Time Frame: 7 and 14 days after surgery

Membrane perforation (yes or no) will be evaluated during the transoperative period. In addition, the following clinical outcomes will be evaluated: Face edema (yes or no);

  • Facial hematoma (yes or no);
  • Presence of suppuration;
  • Suture dehiscence.
7 and 14 days after surgery
Cinical evaluation of Implant failure
Time Frame: through study completion, an average of 18 months
Implant loss may occur during the phase of osseointegration (early) or at a later time when the previously achieved osseointegration is lost (late). Implant loss defined by lack of osseointegration represented by mobility, and will be assessed at throughout the entire search
through study completion, an average of 18 months
Peri-implant clinical examinations
Time Frame: 1 and 12 months after the installation of the prosthesis
probing depth in millimeters will be evaluated at six sites per implant (mesiobuccal, buccal, distobuccal, and mesiolingual/palatal, lingual/palatal, distolingual/palatal).
1 and 12 months after the installation of the prosthesis
Peri-implant clinical examinations
Time Frame: 1 and 12 months after the installation of the prosthesis
submucosal bleeding points after probing will be evaluated at six sites per implant (mesiobuccal, buccal, distobuccal, and mesiolingual/palatal, lingual/palatal, distolingual/palatal).
1 and 12 months after the installation of the prosthesis
Tomographic outcomes
Time Frame: 1 and 12 months after the installation of the prosthesis
The images will be used to measure the marginal bone level mesially and distally in each implant, in relation to a fixed reference point on the implants (upper part of the platform), using a specific program (ImageJ)
1 and 12 months after the installation of the prosthesis

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.
Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
October 1, 2022

Primary Completion (Estimated)

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.
October 1, 2026

Study Completion (Estimated)

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.
October 1, 2026

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 23, 2022

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 3, 2023

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.
November 8, 2023

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.
November 8, 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 3, 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, 2022

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.
  • UFRGS-Cuiaba

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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