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Dental Implant Supported Removable Dental Prostheses

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: NCT03041597
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 prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed versus immediate loading, using abutments with the SynCone® concept for implant-supported detachable dental prosthesis (ISDDP) in the edentulous upper jaw.

Condition or disease Intervention/treatment Phase
Implant Complication Prosthesis Survival Procedure: placement of implants Procedure: immediate loading Procedure: conventional loading Device: Ankylos implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Randomized Controlled Trial Comparing Immediate Loading With Conventional Loading Using Cone-anchored Implant Supported Removable Dental Prostheses, a Two Year Follow up
Actual Study Start Date : September 1, 2009
Actual Primary Completion Date : December 31, 2013
Actual Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
Experimental: Immediate loading Procedure: placement of implants
surgical procedure and placement of implants

Procedure: immediate loading
cone-anchored implant supported removable dental prostheses placement

Device: Ankylos implant
Active Comparator: delayed loading Procedure: placement of implants
surgical procedure and placement of implants

Procedure: conventional loading
cone-anchored implant supported removable dental prostheses placement in 3mo

Device: Ankylos implant



Primary Outcome Measures :
  1. bone loss [ Time Frame: Difference between loading and Year two ]
    measured in mm op peri-apical radiography. Mesial and Distal measurement of implant.


Secondary Outcome Measures :
  1. probing pocket depth [ Time Frame: Difference between loading and Year two ]
    Measurement in mm, 4 sites per implant.

  2. plaque [ Time Frame: Difference between loading and Year two ]
    presence of plaque, 4 sites per implant, Yes=1 or No=0

  3. bleeding on probing [ Time Frame: Difference between loading and Year two ]
    presence of bleeding on probing, 4 sites per implant, Yes=1 or No=0



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:

  • Provision of informed consent
  • Extraction sockets should have healed at least 4 months
  • Sufficient bone volume to place six implants in the maxilla
  • No previous bone augmentation procedures
  • The mandible can have any kind of dentition as long as a well-distributed contact relationship with the new prosthesis in the maxilla can be established.
  • Accepting to comply with study procedures

Exclusion Criteria:

  • Physical or psychological disorders prohibiting implant treatment
  • Heavy smoking (>10 cigarettes/day)
  • Present alcohol and/or drug abuse
  • Physical handicap that may interfere with the ability to perform oral hygiene
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Responsible Party: Lauren Bernard, Periodontist, KU Leuven
ClinicalTrials.gov Identifier: NCT03041597    
Other Study ID Numbers: B32220096198
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prosthesis Failure
Postoperative Complications
Pathologic Processes