Dental Implant Supported Removable Dental Prostheses

February 1, 2017 updated by: Lauren Bernard, KU Leuven

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate loading
surgical procedure and placement of implants
cone-anchored implant supported removable dental prostheses placement
Active Comparator: delayed loading
surgical procedure and placement of implants
cone-anchored implant supported removable dental prostheses placement in 3mo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone loss
Time Frame: Difference between loading and Year two
measured in mm op peri-apical radiography. Mesial and Distal measurement of implant.
Difference between loading and Year two

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
probing pocket depth
Time Frame: Difference between loading and Year two
Measurement in mm, 4 sites per implant.
Difference between loading and Year two
plaque
Time Frame: Difference between loading and Year two
presence of plaque, 4 sites per implant, Yes=1 or No=0
Difference between loading and Year two
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
Difference between loading and Year two

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

December 31, 2013

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 3, 2017

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • B32220096198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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