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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041584
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Collaborator:
Dentsply Sirona Implants
Information provided by (Responsible Party):
Lauren Bernard, KU Leuven

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Implant Failure Nos Procedure: Guided placement Procedure: Non-guided placement Device: Astra Tech TX implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implant-centered Outcomes of Guided Surgery, a 3-year Follow-up: An RCT Comparing Guided Surgery With Non-guided Implant Placement
Actual Study Start Date : January 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Materialise Universal®/ mucosa (Mat Mu) Procedure: Guided placement
implant placement with use of guide

Device: Astra Tech TX implant
Experimental: Materialise Universal®/ bone (Mat Bo) Procedure: Guided placement
implant placement with use of guide

Device: Astra Tech TX implant
Experimental: FacilitateTM/ mucosa (Fac Mu) Procedure: Guided placement
implant placement with use of guide

Device: Astra Tech TX implant
Experimental: FacilitateTM/ bone (Fac Bo) Procedure: Guided placement
implant placement with use of guide

Device: Astra Tech TX implant
Active Comparator: mental navigation (Mental) Procedure: Non-guided placement
conventional implant placement

Device: Astra Tech TX implant
Active Comparator: pilot-drill template (Templ) Procedure: Non-guided placement
conventional implant placement

Device: Astra Tech TX implant



Primary Outcome Measures :
  1. Radiographic outcome [ Time Frame: Change between baseline and 3 Year ]
    Bone loss in mm


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provision of informed consent
  2. An age of at least 18 year
  3. Extraction socket healing for at least 6 months

Exclusion Criteria:

  1. Unlikely to be able to comply with study procedures
  2. History of intravenous bisphosphonate treatment
  3. Medical history that makes implant insertion unfavorable
  4. Current pregnancy
  5. Present alcohol and/or drug abuse
  6. Major systemic diseases
  7. Untreated, uncontrolled caries and/or periodontal disease
  8. History of local irradiation
  9. Need for bone grafting and/or sinus lift in the planned implant area
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Responsible Party: Lauren Bernard, Periodontist, KU Leuven
ClinicalTrials.gov Identifier: NCT03041584    
Other Study ID Numbers: B32220095376
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No