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

ARDEC Academy

Status: Completed

Conditions: Alveolar Bone Loss

Treatments: Device: implant placement

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04022265

protocol #05-2014

Details and patient eligibility

About

The purpose was to evaluate histomorphometrically the early healing at implants installed in sites prepared with either a sonic device or conventional drills.

Full 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

Enrollment: 16 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups

Control Site -Drill site

Active Comparator group

Description:

The control sites (Drills) will be prepared with a lanceolate drill (FS 230, Sweden / Martina), with a maximum diameter of 2.3 mm,

Treatment:

Device: implant placement

Test site -sonic site

Experimental group

Description:

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

Treatment:

Device: implant placement