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

NCT ID: NCT03455361

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

293 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-01

Study Completion Date

2017-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Impaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stark Implant with low primary stability

Patient who had received bone level V-Blast implants with low primary stability.

Stark Implant with low primary stability

Intervention Type PROCEDURE

Stark Implant with primary stability

Patient who had received bone level V-Blast implants and achieved primary stability.

Stark Implant with low primary stability

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stark Implant with low primary stability

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Milan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Giulio Rasperini

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Giulio Rasperini, Prof.

Role: STUDY_DIRECTOR

University of Milan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

StarkImplant

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.