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

U

University of Milan

Status

Completed

Conditions

Dental Impaction

Treatments

Procedure: Stark Implant with low primary stability

Study type

Observational

Funder types

Other

Identifiers

NCT03455361
StarkImplant

Details and patient eligibility

About

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

Full 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.

Enrollment

293 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

293 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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