Alveolar Bone Loss
Conditions
Keywords
maxillary sinus, collagen membrane, CBCT, Histology
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMaxillary sinus augmentation
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.
Sponsors
Corporacion Universitaria Rafael Nunez
ARDEC Academy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
An author not involved in the surgeries will perform the randomization process. The assignments will be sealed within opaque envelopes that will be opened after the completion of the elevation of the sinus mucosa.
Intervention model description
Clinical trial
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| New bone-to-implant contact | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changing in mucosa thickness | 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. |
| New bone density around the mini-implant, from B to A and up to a distance of 400 µm from the implant surface. | 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. |
Countries
Colombia
Outcome results
None listed