- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03041597
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
Status
Completed
Conditions
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
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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