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

March 27, 2018 updated by: Giulio Rasperini, University of Milan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

293

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

the sample is composed by patients who had received Stark bone level V-Blast implants in 4 private offices in Italy. The same surgical protocol was used for all implants and a detailed informed consent was obtained from all patients, and included in their respective charts.

For the study objective were enrolled patient who didn't achieved primary stability at the placement: 26 patient

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

  • Study Director: Giulio Rasperini, Prof., University of Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2016

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

February 16, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (ACTUAL)

March 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StarkImplant

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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