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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
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.
Colombia
Cartagena, Cartagena, Colombia
Changing in height of the elevated zone.
will be assessed in the medial, middle and lateral regions of the elevated zone using the cone beam computerized tomographies
Time frame: 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
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
Time frame: three months of healing
Changing in area of the elevated zone
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.
Time frame: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery
Bone density
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.
Time frame: three months of healing
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