Clinical trial NCT01817361: Oral Health and People With Systemic Sclerosis
Official title: Oral Health and People With Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Sclerosis
Keywords: oral health
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2013-03-25
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults with systemic sclerosis

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.

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

Primary outcomes:
measure: Oral Health Status as measured by periodontal disease
timeFrame: baseline to 2.5 years
measure: Oral Health Status as measured by untreated dental decay
timeFrame: baseline to 2.5 years
measure: Oral Health Status as measured by number of subjects with missing teeth
timeFrame: baseline to 2.5 years
measure: Oral Health Status as measured by the mean size of the aperture among subjects
timeFrame: baseline to 2.5 years
measure: Oral Health Status as measured by perceived dryness
timeFrame: baseline to 2.5 years
measure: Oral Health Status as measured by residual saliva level
timeFrame: baseline to 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: University of Alabama at Birmingham
name: Hon K Yuen, PhD
role: PRINCIPAL_INVESTIGATOR
References: