Edentulous Alveolar Ridge
Conditions
Keywords
Dental Implants, bone healing, clinical trial, histology
Brief 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.
Interventions
PROCEDUREimmediate loading
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.
PROCEDUREnon implant loading
Control implants will receive a healing screw and will remain unloaded
Sponsors
ARDEC Academy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
One of the researchers , neither involved in the selection of the patients nor in the surgical and prosthetic treatment, will carry out electronically the randomization (randomization.com). Will be prepared sealed opaque envelopes and opened at the time of surgery.
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.
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult participants (≥25 years of age) with the need of at least two implants to replace teeth of the jaw will be included. * Natural antagonist teeth have to be present both at test and control sites to guarantee occlusal contacts
Exclusion criteria
* untreated rampant caries or uncontrolled periodontal disease of the remaining teeth * diabetes not controlled diabetes or any other systemic or local disease that could compromise postoperative healing and / or osseointegration * need for systemic corticosteroids or any other medication that could compromise postoperative healing and / or osseointegration * inability or unwillingness to return to follow-up not likely to be able to comply with the study procedures according to the judgment of the investigators * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone to implant contact | 2 months | The linear distances between IS and B (IS-B) and CM and X (CM-X) were measured parallel to the long axis of the implant at both sides of the implant at a magnification of x100. Moreover, the amount of new bone, old bone, total bone (new + old bone = BIC% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone density | 2 months | The total amount of mineralized bone in contact with the implant surface measured histomorphometrically |
Countries
Colombia
Outcome results
None listed