Oral Health and People With Systemic Sclerosis

NCT ID: NCT01817361

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-06-30

Brief Summary

The public health impact of this study will be the application of the greater understanding of the oral health status, oral health related behaviors, and quality of life of patients with systemic sclerosis (scleroderma or SSc). It is hoped that risks and protective factors can be identified to be associated with the oral health status of adults with systemic sclerosis,leading to the development of interventions for improved oral health in this population,and providing the basis for a larger study of oral health problems of adults with systemic sclerosis.

Detailed Description

The broad, long-term objective of our proposed research is to understand the oral health status, oral health-related behaviors, and quality of life in the US population of patients with systemic sclerosis (scleroderma or SSc). SSc is a rare, progressive connective tissue disease that affects predominately women (3.8:1) with a higher risk of the severe form among African-Americans. SSc adults experience manifestations of the systemic disease that include microstomia, xerostomia, and impaired manual dexterity. The two specific aims of this study are: 1) to characterize the oral health status of adults with SSc, and 2) to determine the SSc disease specific manifestations (microstomia, xerostomia, and manual dexterity impairments) that are associated with the severity of oral health problems and oral health-related quality of life among adults with SSc. This first study of US adults with SSc is a cross-sectional survey of 250 adults with SSc in South Carolina. This population is 25% African-American which is similar to the racial distribution of SSc in the US adult population. Data collection includes information on: oral health status (periodontal, dental, mucosal and microbial), oral manifestations of SSc (size of oral aperture, severity of oral dryness, and manual dexterity for oral hygiene), and oral health-related behaviors and quality of life. The oral health status of the South Carolina SSc population will be compared to that of the adult US population based on an analysis of corresponding measures using the National Health and Nutrition Examination Survey 1999-2002 data. Multivariable regression modeling will be used to evaluate hypothesized risk and protective factors that are associated with oral health status in adults with SSc. Results of this study in South Carolina will be used in regional efforts for the development of interventions for improved oral health status of adults with SSc. Second, these results will provide the basis for a larger US study of oral health problems of adults with SSc.

Conditions

Systemic Sclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of SSc according to American College of Rheumatology criteria, and participants are 18 years of age or older at the time of invitation to the study.

Exclusion Criteria

• participants who require antibiotic medication before dental treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Hon K. Yuen, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hon K Yuen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

1R21DE017360-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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