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

Not Applicable

Completed

• Conditions: Alveolar Bone Loss
• Interventions: Device: implant placement

• Registration Number: NCT04022265
• Lead Sponsor: ARDEC Academy

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

Study Timeline

• Study Start: 2016-02-04
• Primary Completion: 2017-08-30
• Study Completion: 2017-12-15
• Status Verified: 2019-07
• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-13
• Study First Posted: 2019-07-17
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Site -Drill site	implant placement	The control sites (Drills) will be prepared with a lanceolate drill (FS 230, Sweden / Martina), with a maximum diameter of 2.3 mm,
Test site -sonic site	implant placement	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

Primary Outcome Measures

Name	Time	Method
New bone in contact with the implant surface	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 Outcome Measures

Name	Time	Method
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	The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis

Trial Locations

Locations (1)

Colombia; 🇨🇴 Cartagena de Indias, Cartagena, Colombia