Tomographic and Histologic Assessment on the Influence of the Use of a Collagen Membrane to Protect the Antrostomy After Maxillary Sinus Floor Augmentation.
- Conditions
- Alveolar Bone ResorptionAlveolar Bone Loss
- Interventions
- Procedure: Maxillary sinus augmentation
- Registration Number
- NCT03899688
- Lead Sponsor
- ARDEC Academy
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control site Maxillary sinus augmentation 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. test site Maxillary sinus augmentation 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.
- Primary Outcome Measures
Name Time Method Changing in height of the elevated zone. 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 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
Name Time Method Changing in area of the elevated zone 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 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.
Trial Locations
- Locations (1)
Colombia
🇨🇴Cartagena de Indias, Cartagena, Colombia