The Effect of Obesity on Oral Peri-implant Health - A Cross-Sectional Study

May 19, 2014 updated by: University of Iowa
In recent years, greater emphasis has been placed on the link between oral and systemic health. Obesity, a growing medical problem worldwide, has been associated with multiple chronic inflammatory diseases such as diabetes mellitus and cardiovascular disease. With respect to the effect of obesity on periodontal health, it has been shown that obese subjects exhibit higher inflammation around natural teeth and are at increased risk of tooth loss than individuals with normal weight. Peri-implantitis, an inflammatory condition of bacterial origin that occurs around oral implants and resembles periodontal disease, has become a serious concern for the dental profession given its increasing prevalence and challenging treatment. There is also strong evidence that individuals with a history of periodontitis are also at risk for peri-implantitis. However, knowledge about the pathogenesis and treatment of peri-implantitis is scarce. Hence, it is extremely important to understand the implications of excessive body fat on peri-implant health. Based on the current understanding on the effect of obesity on systemic and local inflammation around natural teeth, the investigators hypothesize that obesity will have a significant impact on peri-implant health by inducing an increased inflammatory response as measured by clinical as well as molecular markers of inflammation.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Craniofacial Clinical Research Center at the University of Iowa

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects in maintenance dental care with at least one rough surface titanium oral implant in function

Description

Inclusion Criteria:

  • Adults (18 years or older)
  • Currently non-smokers
  • Subjects in maintenance care with adequate dental plaque control (<20% plaque index according to O'Leary et al. 1972)
  • Subjects with at least one rough surface titanium oral implant in function for at least 6 months.

Exclusion Criteria:

  • Edentulous subjects or subjects presenting with blade-type implants and/or implants with smooth surface.
  • Pregnant or nursing women
  • Subjects who have taken medications that are known to alter the oral inflammatory status, such as antibiotics and anti-inflammatory agents, for 3 months prior to the study.
  • Subjects with a history of aggressive periodontitis (As defined by the American Academy of Periodontology).

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

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Single group cross sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Degree of peri-implant inflammation
Time Frame: Single time point - during their single visit (day one)
Single time point - during their single visit (day one)

Collaborators and Investigators

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

Sponsor

University of Iowa

Collaborators

Osseointegration Foundation
University of Iowa Institute of Clinical and Translational Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion

December 6, 2022

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIOB01

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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