Tomographic and Histologic 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 |
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Recruitment Status :
Completed
First Posted : April 2, 2019
Last Update Posted : January 20, 2022
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Sponsor:
ARDEC Academy
Information provided by (Responsible Party):
ARDEC Academy
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alveolar Bone Loss Alveolar Bone Resorption | Procedure: Maxillary sinus augmentation | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 20 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 and Histomorphometric Assessments 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 |
|---|---|
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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.
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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 |
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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 Name: maxillary sinus lift, maxillary sinus elevation |
Primary Outcome Measures :
- 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
- 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
Secondary Outcome Measures :
- 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.
- 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.
Information from the National Library of Medicine
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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
| Colombia | |
| Colombia | |
| Cartagena de Indias, Cartagena, Colombia, 5710 | |
Sponsors and Collaborators
ARDEC Academy
Study Documents (Full-Text)
Documents provided by ARDEC Academy:
Documents provided by ARDEC Academy:
Study Protocol and Statistical Analysis Plan [PDF] January 2, 2021
Publications of Results:
| Responsible Party: | ARDEC Academy |
| ClinicalTrials.gov Identifier: | NCT03899688 |
| Other Study ID Numbers: |
CBCT |
| First Posted: | April 2, 2019 Key Record Dates |
| Last Update Posted: | January 20, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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:
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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 |