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OpenTrials
Completed

NCT Number: NCT03455361

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stark Implant with low primary stability

Procedure

Primary outcomes

  1. Osteointegration of V-Blast surface implant with low primary stability (<10 N/cm) after 4-6 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Acronym: STARKIMPLANT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2018
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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