Colombia
Cartagena, 5710, Colombia
NCT Number: NCT03902457
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.
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Notify Me21 year and older
All sexes
Interventional
Not applicable
Cartagena, 5710, Colombia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: maxillary sinus lift, maxillary sinus elevation
Time frame: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.
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: Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing.
Measurements will be assessed between the most coronal (B) and the most apical (A) contacts of new bone to the implant surface.
Time frame: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.
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: Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing
Measurements will be assessed using a point counting procedure, superposing a lattice with squares of 50 µm over the histological image.
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Histomorphometric and Cone Beam Computed Tomography Assessments on the Influence a Collagen Membrane Placed Subjacent the Sinus Mucosa After Maxillary Sinus Floor Augmentation. A Randomized Clinical Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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