NCT03455361

Evaluation of Bone Level Around Stark Conical Screw Implants With V-Blast Surface

Clinical Osteointegration of Bone Level Implants With Conical Shape and Textured Surface With Low Primary Stability

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 293 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Clinical evaluation of osteointegration of bone level implants (Stark conical screw implants, with V-Blast surface treatment), placed without sufficient primary stability.

Detailed description

26 Implants were placed with a unique operative protocol in 4 private offices. A detailed informed consent was obtained from all patients. Surgical guides were used to achieve the idea implant position and axis. Osteotomy drills were used in the sequence recommended by the implant manufacturer. Bone type was assessed by CT examinations using the classification proposed by Rebaudi. All implants were tested by applying a lateral mild load with a probe in order to verify mobility immediately after placement. Parameter used to assess a low primary stability were: * insertion torque lower than 10 N / cm * slight mobility of implant upon application of lateral load of 250 g After surgery, patients were instructed not to chew or to wear their removable dentures in the treated areas. Follow-up post-operative visits were scheduled at 1 and 4 weeks. At 4-6 months after placement a periapical radiograph was taken, a torque/countertorque test of 30 Ncm was conducted and osteointegrated implants were restored. Patients were recalled, examined, and periapical radiographs were taken for a minimum of 6 months.

Conditions

• Dental Impaction

Interventions

Type	Name	Description
PROCEDURE	Stark Implant with low primary stability

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2018-03-06
• Last updated: 2018-03-29