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

ARDEC Academy

Status: Completed

Conditions: Alveolar Bone Loss; Alveolar Bone Resorption

Treatments: Procedure: Maxillary sinus augmentation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03899688

CBCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

test site

Experimental group

Description:

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.

Treatment:

Procedure: Maxillary sinus augmentation

control site

Active Comparator group

Description:

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.

Treatment:

Procedure: Maxillary sinus augmentation