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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878071
• Other study ID #: UIOB01
• Status: Completed
• Phase: N/A
• First received: January 22, 2013
• Last updated: May 19, 2014
• Start date: June 2012

Study information

• Verified date: May 2014
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA: Institutional Review Board,
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Inflammation
• Obesity
• Peri-implant Inflammation
• Peri-implantitis

Locations

Country	Name	City	State
United States	Craniofacial Clinical Research Center at the University of Iowa	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
University of Iowa	Osseointegration Foundation, University of Iowa Institute of Clinical and Translational Science

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of peri-implant inflammation		Single time point - during their single visit (day one)	No