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Clinical Trials/NCT04022265
NCT04022265
Completed
Not Applicable

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

ARDEC Academy1 site in 1 country16 target enrollmentFebruary 4, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alveolar Bone Loss
Sponsor
ARDEC Academy
Enrollment
16
Locations
1
Primary Endpoint
New bone in contact with the implant surface
Status
Completed
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 4, 2016
End Date
December 15, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
ARDEC Academy
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

New bone in contact with the implant surface

Time Frame: After 6 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 Outcomes

  • The percentage of total mineralized bone in contact with the implant surface.(After 6 weeks to evaluate the healing prior to load with a prosthesis)

Study Sites (1)

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