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OpenTrials
Completed

NCT Number: NCT03041584

Dental Implants Placed by Using a Drill Guide Versus Non-guided Placement. Follow-up Study

To assess implant outcomes, both clinical and radiological, in a randomized study on guided implant placement after 3-year follow-up, compared to non-guided treatment.

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Key information

Conditions

Dental Implant Failure Nos

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of informed consent
  • An age of at least 18 year
  • Extraction socket healing for at least 6 months

Exclusion criteria

  • Unlikely to be able to comply with study procedures
  • History of intravenous bisphosphonate treatment
  • Medical history that makes implant insertion unfavorable
  • Current pregnancy
  • Present alcohol and/or drug abuse
  • Major systemic diseases
  • Untreated, uncontrolled caries and/or periodontal disease
  • History of local irradiation
  • Need for bone grafting and/or sinus lift in the planned implant area

Treatment and study plan

Guided placement

Procedure

implant placement with use of guide

Non-guided placement

Procedure

conventional implant placement

Astra Tech TX implant

Device

Primary outcomes

  1. Radiographic outcome

    Time frame: Change between baseline and 3 Year

    Bone loss in mm

Secondary outcomes

  1. probing pocket depth

    Time frame: Change between baseline and 3 Year

    measurement in mm of pocket around implant, 4 per implant

  2. bleeding on probing

    Time frame: Change between baseline and 3 Year

    measurement of presence of bleeding on probing, Yes =1, No=0. 4 per implant

  3. plaque

    Time frame: Change between baseline and 3 Year

    measurement of presence of plaque, Yes =1, No=0. 4 per implant

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Dentsply Sirona Implants and Consumables

Registry information

Official study title

Implant-centered Outcomes of Guided Surgery, a 3-year Follow-up: An RCT Comparing Guided Surgery With Non-guided Implant Placement

Important dates

Study start
2009
Primary completion
2012
Study completion
2015
First posted
Feb 3, 2017
Registry last updated
Feb 3, 2017

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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