Histomorphometric and Tomographic Assessment on the Influence of the Placement of a Collagen Membrane Subjacent the Sinus Mucosa After Maxillary Sinus Floor Augmentation

ARDEC Academy20 enrolled

Overview

the purpose of the study is to look for differences in dimensional variations of augmented maxillary sinuses with or without the placement of a collagen membrane subjacent the sinus mucosa.

Material and Methods: After the elevation of the maxillary sinus mucosa, a collagen membrane with standard dimensions will be placed at the test sites subjacent the sinus mucosa and the elevated space will be filled with a xenograft, both test and control groups. A collagen membrane will be placed to cover the antrostomy at both groups and sutures will be provided to close the wound. After six months of healing, mini-implants will be installed. After 9 months, biopsies containing the mini-implants will be harvested for histomorphometric analyses. 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). Osseointegration of the mini-implants and dimensional changes over time of soft and hard tissues will be evaluated on the CBCTs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alveolar Bone Loss

Interventions

Maxillary sinus augmentationPROCEDURE

Maxillary sinus augmentation procedures have become increasingly popular procedures before placement of dental implants in posterior maxillae that have suffered severe bone loss due to sinus pneumatization, alveolar bone atrophy, or trauma.

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: * 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.

Locations (1)

Colombia

Cartagena, Cartagena, Colombia

Outcomes

Primary Outcomes

Changing in height of the elevated zone

Measurements will be assessed in the medial, middle and lateral regions of the elevated zone using 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.

New bone-to-implant contact

Measurements will be assessed between the most coronal (B) and the most apical (A) contacts of new bone to the implant surface.

Time frame: Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing.

Secondary Outcomes

Changing in mucosa thickness

Measurements will be assessed in the cone beam computerized tomographies (CBCTs) taken in various periods. Comparisons among the CBCTs of each participants will be performed.

Time frame: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.

New bone density around the mini-implant, from B to A and up to a distance of 400 µm from the implant surface.

Measurements will be assessed using a point counting procedure, superposing a lattice with squares of 50 µm over the histological image.

Time frame: Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing

Data from ClinicalTrials.gov

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