Alveolar Bone Loss
Conditions
Brief summary
The purpose was to evaluate histomorphometrically the early healing at implants installed in sites prepared with either a sonic device or conventional drills.
Detailed description
Sixteen volunteer patients will be recruited. Two titanium mini-implants will be installed in the distal segments of the maxilla in recipient sites prepared with either a sonic device or conventional drills. Biopsies containing the mini-implants will be retrieved after 2 weeks in eight patients, and after 6 weeks in the other eight patients. Histomorphometric analyses will be performed
Interventions
DEVICEimplant placement
Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation
Sponsors
ARDEC Academy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Each patient will receive two mini-implants, installed in recipient sites prepared in the distal segments of the maxilla either with a sonic device or drills. The two recipient sites will be selected prior the surgery, while the type of site preparation will be randomly decided. A researcher, neither involved in the selection of the patients nor in the surgical and prosthetic treatment, carried out electronically the randomization (randomization.com). Sealed opaque envelopes will be prepared and opened at the time of surgery and they will report the position of the sonic sites so that the surgeon will be masked about site preparation type until the surgery. The site will be indicated as mesial or distal position if the two sites will be located in the same quadrant of the maxilla, or as right or left if they will be located in opposite quadrants of the maxilla.
Intervention model description
Clinical Trial
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* presence of an edentulous atrophic zone in the posterior segment of the maxilla * height of the sinus floor ≥10 mm * ≥ 25 years of age; * smoking ≤10 cigarettes per day * good general health * no contraindication for oral surgical procedures * not being pregnant.
Exclusion criteria
* presence of systemic disorders * chemotherapy or radiotherapy * smokers \>10 cigarettes per day * previous bone augmentation procedures in the same region.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New bone in contact with the implant surface | After 2 weeks to evaluate the healing prior to load with a prosthesis | The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of total mineralized bone in contact with the implant surface. | After 2 weeks to evaluate the healing prior to load with a prosthesis | The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis |
Other
| Measure | Time frame | Description |
|---|---|---|
| pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels | After 2 weeks to evaluate the early haling prior to load with a prosthesis | The percentages of pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants and vessels in contact with the implant surface will be evaluated in the histomorphometric analysis. |
Countries
Colombia
Outcome results
None listed