NCT03455361

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
293

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

February 16, 2018

Last Update Submit

March 27, 2018

Conditions

Dental Impaction

Keywords

implant stability, dental implants, primary stability

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

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

Interventions

Stark Implant with low primary stabilityPROCEDURE
Stark Implant with low primary stabilityStark Implant with primary stability

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • patient without Stark implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Giulio Rasperini, Prof.

    University of Milan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2018

First Posted

March 6, 2018

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03