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

Completed

• Conditions: Dental Impaction
• Interventions: Procedure: Stark Implant with low primary stability

• Registration Number: NCT03455361
• Lead Sponsor: University of Milan

Brief 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.

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-27
• Status Verified: 2018-03
• Study First Posted: 2018-03-06
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

Inclusion Criteria

• patient who had received Stark bone level V-Blast implants in 4 private offices in Italy
• patient subscribed a detailed informed consent
• same surgical protocol was applied

Exclusion Criteria

• patient without Stark implant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stark Implant with low primary stability	Stark Implant with low primary stability	Patient who had received bone level V-Blast implants with low primary stability.
Stark Implant with primary stability	Stark Implant with low primary stability	Patient who had received bone level V-Blast implants and achieved primary stability.

Primary Outcome Measures

Name	Time	Method
Osteointegration of V-Blast surface implant with low primary stability (<10 N/cm) after 4-6 months	4 to 6 months	After 4-6 months, implant without good primary stability were evaluatd. A periapical radiograph was taken, a torque/countertorque test of 30 Ncm was conducted and osteointegrated implants were restored.