Histomorphometric and Tomographic Assessment on the Influence of the Placement of a Collagen Membrane Subjacent the Sinus Mucosa After Maxillary Sinus Floor Augmentation

September 30, 2020 updated by: ARDEC Academy

Histomorphometric and Cone Beam Computed Tomography Assessments on the Influence a Collagen Membrane Placed Subjacent the Sinus Mucosa After Maxillary Sinus Floor Augmentation. A Randomized Clinical Trial.

the purpose of the study is to look for differences in dimensional variations of augmented maxillary sinuses with or without the placement of a collagen membrane subjacent the sinus mucosa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Material and Methods: After the elevation of the maxillary sinus mucosa, a collagen membrane with standard dimensions will be placed at the test sites subjacent the sinus mucosa and the elevated space will be filled with a xenograft, both test and control groups. A collagen membrane will be placed to cover the antrostomy at both groups and sutures will be provided to close the wound. After six months of healing, mini-implants will be installed. After 9 months, biopsies containing the mini-implants will be harvested for histomorphometric analyses. CBCTs will be taken for all patients before surgery (T0), after 1 week from sinus floor augmentation (T1) and after 9 months of healing (T2). Osseointegration of the mini-implants and dimensional changes over time of soft and hard tissues will be evaluated on the CBCTs.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • 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

  • Colombia
    • Cartagena
      • Cartagena de Indias, Cartagena, Colombia, 5710
        • Colombia

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

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of an edentulous atrophic zone in the posterior segment of the maxilla
  • height of the sinus floor ≤4 mm
  • desiring a prosthetic restoration of the zone using a fix prosthesis supported by implants;
  • ≥ 21 years of age
  • good general health
  • no contraindication for oral surgical procedures
  • not being pregnant

Exclusion Criteria:

  • present a systemic disordered
  • had a chemotherapic or radiotherapeutic treatment
  • are smokers >10 cigarettes per day
  • have an acute or a chronic sinusitis
  • had a previous bone augmentation procedures in the zone of interest.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: test site
The sinus mucosa will be elevated and, at the test sites, a collagen membrane will be placed subjacent the sinus mucosa
Procedure: Maxillary sinus augmentation
Maxillary sinus augmentation procedures have become increasingly popular procedures before placement of dental implants in posterior maxillae that have suffered severe bone loss due to sinus pneumatization, alveolar bone atrophy, or trauma.
Other Names:
  • maxillary sinus lift, maxillary sinus elevation
EXPERIMENTAL: control site
The sinus mucosa will be elevated and, at the control sites, a collagen membrane will not be placed subjacent the sinus mucosa
Procedure: Maxillary sinus augmentation
Maxillary sinus augmentation procedures have become increasingly popular procedures before placement of dental implants in posterior maxillae that have suffered severe bone loss due to sinus pneumatization, alveolar bone atrophy, or trauma.
Other Names:
  • maxillary sinus lift, maxillary sinus elevation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing in height of the elevated zone
Time Frame: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.
Measurements will be assessed in the medial, middle and lateral regions of the elevated zone using the cone beam computerized tomographies (CBCTs) taken in various periods.
The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.
New bone-to-implant contact
Time Frame: Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing.
Measurements will be assessed between the most coronal (B) and the most apical (A) contacts of new bone to the implant surface.
Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing in mucosa thickness
Time Frame: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.
Measurements will be assessed in the cone beam computerized tomographies (CBCTs) taken in various periods. Comparisons among the CBCTs of each participants will be performed.
The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.
New bone density around the mini-implant, from B to A and up to a distance of 400 µm from the implant surface.
Time Frame: Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing
Measurements will be assessed using a point counting procedure, superposing a lattice with squares of 50 µm over the histological image.
Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing

Collaborators and Investigators

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

Sponsor

ARDEC Academy

Collaborators

Corporacion Universitaria Rafael Nunez

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)

February 3, 2016

Primary Completion (ACTUAL)

October 30, 2018

Study Completion (ACTUAL)

December 30, 2018

Study Registration Dates

First Submitted

March 30, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (ACTUAL)

April 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBCT sinus membrane

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the results will be published in a Journal

IPD Sharing Time Frame

will be become available after the time required by the journal for publication and will be available all the time the journal is active.

IPD Sharing Supporting Information Type

  • 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

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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