Histomorphometric and Tomographic Assessment on the Influence of the Placement of a Collagen Membrane Subjacent the Sinus Mucosa After Maxillary Sinus Floor Augmentation
- Conditions
- Alveolar Bone Loss
- Interventions
- Procedure: Maxillary sinus augmentation
- Registration Number
- NCT03902457
- Lead Sponsor
- ARDEC Academy
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control site Maxillary sinus augmentation The sinus mucosa will be elevated and, at the control sites, a collagen membrane will not be placed subjacent the sinus mucosa test site Maxillary sinus augmentation The sinus mucosa will be elevated and, at the test sites, a collagen membrane will be placed subjacent the sinus mucosa
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Colombia
🇨🇴Cartagena de Indias, Cartagena, Colombia