Oral Health and People With Systemic Sclerosis

March 27, 2017 updated by: Hon K. Yuen, PhD, University of Alabama at Birmingham
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adults with systemic sclerosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oral Health Status as measured by periodontal disease
Time Frame: baseline to 2.5 years
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
Time Frame: baseline to 2.5 years
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
Time Frame: baseline to 2.5 years
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
Time Frame: baseline to 2.5 years
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
Time Frame: baseline to 2.5 years
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
Time Frame: baseline to 2.5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hon K Yuen, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R21DE017360-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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