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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902457
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Corporacion Universitaria Rafael Nunez
Information provided by (Responsible Party):
ARDEC Academy

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alveolar Bone Loss Procedure: Maxillary sinus augmentation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical trial
Masking: Double (Care Provider, Investigator)
Masking Description: An author not involved in the surgeries will perform the randomization process. The assignments will be sealed within opaque envelopes that will be opened after the completion of the elevation of the sinus mucosa.
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : February 3, 2016
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

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 Name: 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 Name: maxillary sinus lift, maxillary sinus elevation




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902457


Locations
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Colombia
Colombia
Cartagena de Indias, Cartagena, Colombia, 5710
Sponsors and Collaborators
ARDEC Academy
Corporacion Universitaria Rafael Nunez
  Study Documents (Full-Text)

Documents provided by ARDEC Academy:
Publications of Results:

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Responsible Party: ARDEC Academy
ClinicalTrials.gov Identifier: NCT03902457    
Other Study ID Numbers: CBCT sinus membrane
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the results will be published in a Journal
Supporting Materials: Clinical Study Report (CSR)
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.

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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
Keywords provided by ARDEC Academy:
maxillary sinus
collagen membrane
CBCT
Histology
Additional relevant MeSH terms:
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Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases