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Completed

NCT Number: NCT03845738

Retrospective Evaluation of Clinical Performance of the Astra Tech Implant System EV When Used in Everyday Practice

This study is designed as a retrospective, multi-center study. The study population consist of subjects who received one or more OsseoSpeed EV implants during the period January 1st 2015 to December 31st 2016. Two hundred subjects will be enrolled, approximately 25-30 subjects per site. The study includes retrospective data collection from subjects' medical records and data collection from one prospective study visit with a clinical examination.

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Key information

Conditions

Dental Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centrum voor tandheelkunde Geluwe, Geluwe, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject ≥ 18 years at time of implant installation.
  • Subject signed and dated the informed consent form.
  • Having installed one or more OsseoSpeed EV implants between January 1st 2015 and December 31st 2016.

Exclusion criteria

  • Unlikely to be able to comply with study procedures, according to Investigator's judgement.
  • Subject is not willing to participate in the study or not able to understand the content of the study.
  • Involvement in the planning or conduct of the study.
  • Simultaneous participation in another clinical study that may interfere with the present study.
  • Severe non-compliance to Clinical Investigation Plan (CIP) as judged by the Investigator and/or Dentsply Sirona Implants.

Treatment and study plan

OsseoSpeed EV implant

Device

The investigational product (OsseoSpeed EV implant) is already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products.

Primary outcomes

  1. Percent of Survived Implants at Time of the Follow-up Visit

    Time frame: Up to 66 months post-procedure.

    Survival defined as implant in situ at time of the follow-up visit. Primary analysis performed on implant level.

Secondary outcomes

  1. Percent of Successful Implants at Time of the Follow-up Visit

    Time frame: Up to 66 months post-procedure.

    Implant success defined as implant in situ at time of the follow-up visit and no Adverse Device Effects (ADEs) related to the implant or adjacent peri-implant tissues reported from the day when the study product(s) was installed until the end of the study. Analysis performed on implant level.

  2. Percent of Successful Prosthetics at Time of the Follow-up Visit

    Time frame: Up to 66 months post-procedure.

    Prosthetic success defined as implant, abutment and restoration in situ at time of the follow-up visit and no Adverse Device Effects (ADEs) related to the reconstruction or adjacent peri-implant tissues reported from the day when the study position(s) was permanently included in a prosthetic restoration until the end of the study. Analysis performed on implant level.

  3. Marginal Bone Levels (MBL)

    Time frame: Up to 66 months post-procedure.

    Bone tissue response was evaluated for each investigational position by measuring Marginal Bone Levels (MBL) on the radiographs.

    Intraoral radiographs were used. Analysis performed on implant level.

  4. Soft Tissue Response Measured Through Probing Pocket Depth (PPD) at Time of Follow-up Visit

    Time frame: Up to 66 months post-procedure.

    Soft tissue response evaluated by measuring the PPD of each study position. PPD was evaluated using a periodontal probe. PPD was measured as the distance from the mucosal margin to the bottom of the probable pocket in whole millimeters. PPD mean values, and frequencies per depth, were calculated for each study position. Analysis performed on implant level.

  5. Soft Tissue Response Measured Through Bleeding on Probing (BoP) at Time of Follow-up Visit

    Time frame: Up to 66 months post-procedure.

    Presence of BoP was evaluated using a periodontal probe. The proportion of surfaces that showed presence of bleeding were calculated and presented for each study implant position. Analysis performed on implant level.

  6. Soft Tissue Response Measured Through Presence of Plaque at Time of Follow-up Visit

    Time frame: Up to 66 months post-procedure.

    Plaque was recorded as presence or absence of plaque by visual inspection. The proportion of surfaces that showed presence of plaque were calculated and presented for each study implant position. Analysis performed on implant level.

  7. Patient Reported Outcome on Implant Level at Time of Follow-up Visit

    Time frame: Up to 66 months post-procedure.

    Subject satisfaction was evaluated using a short subject questionnaire of each investigational implant position. Subjects were asked to complete a questionnaire to state their opinion about: 1) chewing function and 2) esthetics and 3) overall level of treatment satisfaction.

    For question 1) the scale ranged from Very bad (1), Bad (2), Neither bad or good (3), Good (4), and Very good (5).

    For questions 2) and 3) the scale ranged from Very dissatisfied (1), Dissatisfied (2), Neither dissatisfied nor satisfied (3), Satisfied (4), and Very satisfied (5).

    Authorized investigational site personnel provided the questionnaire during the investigational visit. The subject was instructed to complete it, one per investigational position, and return it for data entry by site personnel into the electronic-Case Report Form (eCRF). The frequencies of each score were calculated for each question and investigational position. Analysis performed on implant level.

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2019
Registry last updated
Mar 18, 2024

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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