Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Influence of Gum Disease Treatment on Long-term Dental Implant Success

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: NCT03841656
Recruitment Status : Unknown
Verified February 2019 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of this study is to evaluate the influence of periodontal care response on long term dental implant success. Investigator's hypothesis is that patients who do not well respond to periodontal care have more chance to develop peri-implant complications at long-term. The second purpose of this study is to evaluate the influence of other local, systemic, behavioral, and implant's related risk factors

Condition or disease Intervention/treatment
Periodontitis Procedure: PARORISKIMPLANT

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Influence of Periodontal Care Response on Implant Treatment Outcomes at Long-term
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Procedure: PARORISKIMPLANT
    Patients attending periodontal and implant treatment at the Department of Periodontology of the Dental Faculty at Strasbourg, France, between 2000-2015.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Presence of peri-implantitis as measured by probing depth [ Time Frame: At least 3 years after dental implant placement ]
    The implant has a probing depth more than or equal to 4 mm

  2. Presence of peri-implantitis as measured by erythema [ Time Frame: At least 3 years after dental implant placement ]
    The implant has bleeding on probing

  3. Presence of peri-implantitis as measured by radiographic bone loss [ Time Frame: At least 3 years after dental implant placement ]
    The implant has a radiographic bone loss when compared to previous radiographs


Secondary Outcome Measures :
  1. Implant survival [ Time Frame: At least 3 years after dental implant placement ]
    presence of implant on arch Peri-implant mucositis: presence of bleeding on probing


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient attending periodontal and implant treatment at the Department of Periodontology of the Dental Faculty at Strasbourg, France, between 2000-2015.
Criteria

Inclusion Criteria:

Patient attending supporting periodontal therapy with at least one implant placed for more than 3 years

  • Patient with more than 12 teeth at baseline
  • Patient with demographic, periodontal, implant data recording
  • patient aged >30 years at Baseline

Exclusion criteria:

  • Patient needed antibiotic prophylaxis
  • Uncontrolled diabetes
  • Systemic inflammatory or autoimmune diseases
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841656


Contacts
Layout table for location contacts
Contact: Olivier HUCK 00333 ext 116947 olivier.huck@chru-strasbourg.fr

Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03841656    
Other Study ID Numbers: 67RC001
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases