NCT01878071

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 14, 2013

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

January 22, 2013

Last Update Submit

May 19, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Degree of peri-implant inflammation

    Single time point - during their single visit (day one)

Study Arms (1)

Single group cross sectional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Craniofacial Clinical Research Center at the University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

  • Koldsland OC, Scheie AA, Aass AM. Prevalence of peri-implantitis related to severity of the disease with different degrees of bone loss. J Periodontol. 2010 Feb;81(2):231-8. doi: 10.1902/jop.2009.090269.

    PMID: 20151801BACKGROUND
  • Al-Zahrani MS, Bissada NF, Borawskit EA. Obesity and periodontal disease in young, middle-aged, and older adults. J Periodontol. 2003 May;74(5):610-5. doi: 10.1902/jop.2003.74.5.610.

    PMID: 12816292BACKGROUND

MeSH Terms

Conditions

ObesityPeri-Implantitis

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

June 14, 2013

Study Start

June 1, 2012

Primary Completion

June 1, 2013

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations