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OpenTrials
Completed

NCT Number: NCT03041597

Dental Implant Supported Removable Dental Prostheses

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.

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Key information

Conditions

Implant Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Prosthesis Survival

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
  • 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

Treatment and study plan

Placement of implants

Procedure

surgical procedure and placement of implants

Immediate loading

Procedure

cone-anchored implant supported removable dental prostheses placement

Conventional Loading

Procedure

cone-anchored implant supported removable dental prostheses placement in 3mo

Ankylos implant

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Dentsply Sirona Implants and Consumables

Registry information

Official study title

An Randomized Controlled Trial Comparing Immediate Loading With Conventional Loading Using Cone-anchored Implant Supported Removable Dental Prostheses, a Two Year Follow up

Important dates

Study start
2009
Primary completion
2013
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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