Oral Health and People With Systemic Sclerosis

NCT01817361 | Completed

• 1 other identifier: 1R21DE017360-01A2
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis

Keywords

oral health

Outcome Measures

Primary Outcomes (6)

• Oral Health Status as measured by periodontal disease

  Periodontal disease will be measured by the loss of attachment of 4mm or more at one or more sites. The number of subjects presenting with periodontal disease will be reported.

  baseline to 2.5 years

• Oral Health Status as measured by untreated dental decay

  Measure description: Untreated dental decay will be determined by either the presence of coronal caries quantified by using the D component of the DMFS Index. The DMFS Index quantifies the dental caries experience by the number of decayed (D), missing (M), and filled (F) dental surfaces (S). OR by identification of the presence of root caries, which will be recorded following the Centers for Disease Control and Prevention (CDC), National Health and Nutrition Examination Survey (NHANES) 1999-2002 protocol (https://wwwn.cdc.gov/nchs/data/nhanes3/manuals/dental.pdf). The protocol includes a half-mouth examination is done using a quadrant from each the maxillary and mandibular regions for a maximum of 14 teeth (third molars excluded). For each participant, the quadrant selection is randomly generated by the computer program. The number of subjects presenting with untreated dental decay will be reported

  baseline to 2.5 years

• Oral Health Status as measured by number of subjects with missing teeth

  Measure description: The number of missing teeth (T) is quantified using the D (decayed) component of the DMFT Index. The DMFT Index quantifies the dental caries experience by the number of decayed (D), missing (M), and filled (F) teeth (T). The number of subjects presenting with missing teeth will be reported.

  baseline to 2.5 years

• Oral Health Status as measured by the mean size of the aperture among subjects

  Size of oral aperture will be measured by both the maximum incisor and maximum lip aperture to define size of oral aperture. Maximum incisor aperture (i.e., interincisal distance) will be the vertical distance in millimeters from the bottom of the maxillary right central incisor to the top of the mandibular incisor when the participants open their mouth as wide as possible. Maximum lip aperture (i.e., interlabial distance) is the vertical distance in millimeters from the bottom of the top lip to the top of the bottom lip when the participants open their mouth as wide as possible. An average of three successive trials for each oral aperture measurement will be used. Microstomia is defined as the interlabial distance \<45 mm or the interincisal distance \<40 mm. Further, moderate microstomia is when the interincisal distance is between 31-40 mm, and severe microstomia is when the interincisal distance is less than 30 mm. The mean size of the aperture among subjects will be reported.

  baseline to 2.5 years

• Oral Health Status as measured by perceived dryness

  The presence or absence of oral dryness will be quantified using the perceived oral dryness index. The subjective experience of dry mouth will be assessed by asking each participant about the amount of saliva in the mouth and about dry mouth during meals. Four self-reported questions developed by Fox et al .have been shown to significantly correlate with unstimulated salivary output and salivary flow rates. A "yes" response to one or more of the following four questions is considered positive for xerostomia: (1) Does your mouth feel dry when eating a meal? (2) Do you sip liquids to aid in swallowing dry foods? (3) Do you have difficulties swallowing any foods? (4) Does the amount of saliva in your mouth seem to be too little? The number of subjects presenting with perceived dryness will be reported.

  baseline to 2.5 years

• Oral Health Status as measured by residual saliva level

  The severity of oral dryness is quantified by measuring the residual saliva levels at the lower inner lip. The lower inner lip location for residual saliva is suggested as a sensitive measure of oral dryness. Participants are instructed not to eat or drink for at least one hour before the measurement. The residual saliva in this location will be collected using a standard SialopaperTM strip (Ora Flow Inc) which is held with a cotton plier. Participants are instructed to dry swallow and the mucosal surface of their lower inner lip as indicated by DiSabato-Mordarski \& Kleinberg will be immediately touched with the SialopaperTM strip in a dipstick fashion for 5 seconds. The amount of absorbed saliva (in μl) on the strip will be measured electronically with the Periotron 8000® micro-moisture meter (Ora Flow Inc). The score will range from 0-200. The mean residual saliva level among subjects will be reported.

  baseline to 2.5 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults with systemic sclerosis

You may qualify if:

• 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.

You may not qualify if:

• participants who require antibiotic medication before dental treatment

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Hon K Yuen, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 25, 2013
• Study Start: October 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

US (1)