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

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ClinicalTrials.gov Identifier: NCT03899688
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
ARDEC Academy

Brief Summary:
the aim of the present study was to evaluate the dimensional variation and healing of the antrostomy left unprotected or protected with a collagen membrane

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

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 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.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: test and control group
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: the surgeon will be blinded until the maxillary sinus augmentation is filled with the biomaterial.
Primary Purpose: Treatment
Official Title: Cone Beam Computed Tomography Assessment on the Influence a Collagen Membrane Placed on the Antrostomy After Maxillary Sinus Floor Augmentation. A Randomized Clinical Trial.
Actual Study Start Date : February 20, 2015
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : March 2, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

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.
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 Name: maxillary sinus lift, maxillary sinus elevation

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.
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 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 ]
    will be assessed in the medial, middle and lateral regions of the elevated zone using the cone beam computerized tomographies


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gender identity
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: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.

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): NCT03899688


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

Documents provided by ARDEC Academy:

Publications of Results:

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Responsible Party: ARDEC Academy
ClinicalTrials.gov Identifier: NCT03899688     History of Changes
Other Study ID Numbers: CBCT
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
antrostomy
Maxillary sinus augmentation
collagen membrane
biomaterial

Additional relevant MeSH terms:
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Bone Resorption
Alveolar Bone Loss
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases