Tomographic and Histologic Assessment on the Influence of the Use of a Collagen Membrane to Protect the Antrostomy After Maxillary Sinus Floor Augmentation.

January 5, 2022 updated by: ARDEC Academy

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

the aim of the present study was to evaluate the dimensional variation and osseointegration of mini-implants at augmented sinus with the antrostomy left unprotected or protected with a collagen membrane.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Schneiderian mucosa will be elevated and the created space will be filled with a natural bovine bone grafting material (Cerabone® 1-2 mm, Botiss Biomaterials GmbH). In ten patients randomly selected (control sties), a native collagen membrane made of porcine dermis (Collprotect®, Botiss Biomaterials GmbH) will be placed on the antrostomy. In another ten patients of the test group, the antrostomy will be left without the membrane. The flaps will be sutured and anti-inflammatory drugs and antibiotics will be administrated to the patients. The sutures will be removed after 7 days. After 6 months of healing, two mini-implants with different surface will be installed and retrieved after further 3 months for histomorphometric evaluations.

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) and evaluation of dimensional variations over time of soft and hard tissues will be performed.

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 to 75 years (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:The patients will be excluded if they 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 space obtained underneath the sinus mucosa will be filled with the xenograft without protecting the antrostomy with a collagen membrane in the test sites. Bone to implant contact was measured at the turned and machined surface.
Procedure: Maxillary sinus augmentation
Surgical technique for increasing the vertical bone height of the posterior maxilla an antrostomy of about 5 mm in height and 10 mm long will be prepared using a diamond insert mounted on a sonic-air surgical instrument. The Schneiderian membrane will be elevated and clinical measurements will be performed using an UNC 15 probe. The space obtained underneath the sinus mucosa will be filled with the xenograft and a resorbable collagen membrane will be placed to cover the antrostomy only at the randomly selected control sites.
Other Names:
  • maxillary sinus lift, maxillary sinus elevation
ACTIVE_COMPARATOR: control site
The space obtained underneath the sinus mucosa will be filled with the xenograft and a resorbable collagen membrane will be placed to cover the antrostomy only at the randomly selected control sites. Bone to implant contact was measured at the turned and machined surface.
Procedure: Maxillary sinus augmentation
Surgical technique for increasing the vertical bone height of the posterior maxilla an antrostomy of about 5 mm in height and 10 mm long will be prepared using a diamond insert mounted on a sonic-air surgical instrument. The Schneiderian membrane will be elevated and clinical measurements will be performed using an UNC 15 probe. The space obtained underneath the sinus mucosa will be filled with the xenograft and a resorbable collagen membrane will be placed to cover the antrostomy only at the randomly selected control sites.
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
will be assessed in the medial, middle and lateral regions of the elevated zone using the cone beam computerized tomographies
The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery
Bone-to-implant contact between the different surfaces and between membrane / no membrane groups
Time Frame: three months of healing
Measurements of new bone formation will be assessed on the histological images taken from the slides and performed between the most coronal bone contact to the surface and the apex of the mini-implant. Comparisons among test and control (without or with a collagen membrane of the access window) and between the two different surface conformations will be performed
three months of healing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing in area of the elevated zone
Time Frame: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery
The area will be delineated by the sinus bone walls and the sinus mucosa. The changes will be evaluated on 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
Bone density
Time Frame: three months of healing
Measurements of new bone formation will be assessed on the histological images taken from the slides and performed between the most coronal bone contact to the surface and the apex of the mini-implant. Comparisons among test and control (without or with a collagen membrane of the access window) and between the two different surface conformations will be performed.
three months of healing

Collaborators and Investigators

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

Sponsor

ARDEC Academy

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 20, 2015

Primary Completion (ACTUAL)

December 21, 2018

Study Completion (ACTUAL)

March 2, 2019

Study Registration Dates

First Submitted

March 23, 2019

First Submitted That Met QC Criteria

March 30, 2019

First Posted (ACTUAL)

April 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBCT

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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