Pilot Testing on New NHANES 2009-10 Content

Attachment C.

Protocol for Oral Health Pilot Study (ages 2+)

National Health and Nutrition Examination Survey (NHANES)

Oral Health Pilot Study

OMB no. 0920-0237

Expires: 12/31/2011

Assurance of confidentiality – All information which would permit identification of an

individual, a practice, or an establishment will be held confidential, will be used for

statistical purposes only by NCHS staff, contractors, and agents only when required and with necessary controls, and will not be disclosed or released to other persons without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 USC 242m) and the Confidential Information Protection and Statistical Efficiency Act (PL-107-347).

Public reporting burden of this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333. ATTN: PRA (0920-0237).

Oral Health Pilot Study Protocol:

Eligibility: Sample persons aged 2 years or older are eligible for the Oral Health Pilot Study.

Informed Consent: Informed consent will be obtained as a part of standard NHANES consenting procedures.

Exclusion Criteria: There is no overall exclusion for the oral health exam. However, respondents answering yes to any one of the following questions will be excluded from having the periodontal portion of the oral health assessment.

Have you lost all of your upper and lower natural (permanent) teeth?

Have you had a heart transplant?

Do you take antibiotics prior to dental care?

Do you have an artificial heart valve?

Have you had heart disease since birth?

Have you had Bacterial Endocarditis?

Have you ever had Rheumatic fever?

Have you ever had Kidney disease requiring renal dialysis?

Have you ever had A hip bone or joint replacement?

Study Design: A dentist will perform assessments for tooth count, comprehensive dental caries, dental sealants using NHANES 1999-2004 methods. Dental enamel fluorosis assessment using the imaging methods in pilot testing during 2009-2010 will be added. And methods from the 1999-2004 NHANES fluorosis assessment (Dean’s index) will be reintroduced, to create a bridge between the two methods for monitoring trends in dental enamel fluorosis. The dentist will continue with the comprehensive periodontal exam, medical exclusion questions, and recommendation for care/referral.

Data Collection: Participants will take the examination in the Mobile Examination Center (MEC) oral health room.

Report of Findings: Results will not be reported to the participant.