NCT03841656

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

February 11, 2019

Last Update Submit

February 12, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Presence of peri-implantitis as measured by probing depth

    The implant has a probing depth more than or equal to 4 mm

    At least 3 years after dental implant placement

  • Presence of peri-implantitis as measured by erythema

    The implant has bleeding on probing

    At least 3 years after dental implant placement

  • Presence of peri-implantitis as measured by radiographic bone loss

    The implant has a radiographic bone loss when compared to previous radiographs

    At least 3 years after dental implant placement

Secondary Outcomes (1)

  • Implant survival

    At least 3 years after dental implant placement

Interventions

Patients attending periodontal and implant treatment at the Department of Periodontology of the Dental Faculty at Strasbourg, France, between 2000-2015.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient attending periodontal and implant treatment at the Department of Periodontology of the Dental Faculty at Strasbourg, France, between 2000-2015.

You may qualify if:

  • 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

You may not qualify if:

  • Patient needed antibiotic prophylaxis
  • Uncontrolled diabetes
  • Systemic inflammatory or autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Papalou I, Vagia P, Cakir A, Tenenbaum H, Huck O, Davideau JL. Influence of Periodontitis, Implant, and Prosthesis Characteristics on the Peri-Implant Status: A Cross-Sectional Study. Int J Dent. 2022 Feb 7;2022:9984871. doi: 10.1155/2022/9984871. eCollection 2022.

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 15, 2019

Study Start

March 1, 2019

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

February 15, 2019

Record last verified: 2019-02