Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills

Study Overview
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Brief Summary
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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
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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

Official Title
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Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills. A Split-mouth Histomorphometric Randomized Controlled Trial

Conditions
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Alveolar Bone Loss

Intervention / Treatment
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* Device: implant placement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinical Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Site -Drill site<br>The control sites (Drills) will be prepared with a lanceolate drill (FS 230, Sweden / Martina), with a maximum diameter of 2.3 mm, | Device: implant placement<br>* Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation<br>* Other names: implant surgery, prosthesis;|
| Experimental: Test site -sonic site<br>test sites will be prepared with conical diamond inserts of increasing diameter (SFS99.000.014 to SFS99.000.024, Komet-Brasseler-GmbH, Germany) mounted on a sonic-air surgical instrument | Device: implant placement<br>* Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation<br>* Other names: implant surgery, prosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New bone in contact with the implant surface | The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis | After 2 weeks to evaluate the healing prior to load with a prosthesis | 
| New bone in contact with the implant surface | The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis | After 6 weeks, to evaluate the healing prior to load with a prosthesis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of total mineralized bone in contact with the implant surface. | The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis | After 2 weeks to evaluate the healing prior to load with a prosthesis | 
| The percentage of total mineralized bone in contact with the implant surface. | The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis | After 6 weeks to evaluate the healing prior to load with a prosthesis |