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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03455361
Acronym
STARKIMPLANT
Enrollment
293
Registered
2018-03-06
Start date
2016-03-01
Completion date
2017-03-01
Last updated
2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Impaction

Keywords

implant stability, dental implants, primary stability

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.

Interventions

PROCEDUREStark Implant with low primary stability

Sponsors

University of Milan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Osteointegration of V-Blast surface implant with low primary stability (<10 N/cm) after 4-6 months4 to 6 monthsAfter 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026