Immediate Loading a Histological Study
Condition: Edentulous Alveolar Ridge
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): immediate loading; non implant loading
Intervention type(s): Procedure; Procedure
Intervention description(s): The participants will be assigned to immediate or delayed functional loading groups. In each participant, edentulous areas with adequate thickness of the alveolar bone crest will be identified and at least two sites will be identified for implant installation. All implant recipient sites will be sub-prepared to allow good stability of the implants. Experimental mini-implants (Sweden & Martina, Due Carrare, Padova, Italy), 3.5 mm in diameter and with an intraosseous portion of 4 mm in length will be installed.
Immediate loading group - A prosthetic component will be applied over the trial implants. Impressions will be taken and a crown / bridge will be provided to patients in one day.; Control implants will receive a healing screw and will remain unloaded
Other intervention name(s): implant surgery, prosthesis; control site
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split mouth, At least one site will be used as a test and one as a control where experimental mini-implants will be installed.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Dental Implants; bone healing; clinical trial; histology