Edentulous Alveolar Ridge Clinical Trial
Official title:
Immediate Loading-A Histological Study in Humans
Twelve participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. At least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments. One site will be used as a test and one as a control where experimental mini-implants will be installed. Reconstructive surgical procedures will be applied at the biopsy sites.
Objective: - To evaluate histologically the influence of the functional load on implants,
both immediate and delayed.
Material and methods: 12 participants with edentulous alveolar crests in the distal portion
of the arches will be included in the study. At least two implant sites will be identified in
each patient and will be sub-prepared with drills or sonic instruments to obtain a high
degree of torque to ensure optimum primary stability. At least one site will be used as a
test and one as a control where experimental mini-implants will be installed. Test sites will
be loaded immediately. The control sites will remain unloaded. After 2 months, mini-implants
will be recovered as planned for each group. Reconstructive surgical procedures will be
applied at the biopsy sites, if necessary, using autologous bone or bone substitutes and
membranes. Standard implants will be installed during the same surgical session and, after 2
months, the planned prosthesis will be performed. Patients will be followed for at least 2
years for evaluation and intervention, if necessary.
Biopsies will be included in resin to obtain wear cuts for histomorphometric analysis. The
bone histomorphometry will be evaluated and statistical analysis will be carried out.
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