Gastroesophageal Reflux Clinical Trial
This study investigates the prevalence and pathophysiology of dental and periodontal
involvement in pediatric patients with symptomatic or asymptomatic gastroesophageal reflux
(GER) or gastroesophageal reflux disease (GERD). Primary objectives are to compare the
prevalence of oral disease in children with and without a diagnosis or symptoms/signs of
GERD in a cross-sectional study. Secondary objectives are to examine factors that might lead
to the pathogenesis of the dental and periodontal lesions observed in this group of
subjects.
The primary hypothesis is to prove that children aged 10-18 years diagnosed with or having
symptoms or signs of GERD have a significantly higher amount of dental erosions in
comparison to a matched control group.
Secondary hypotheses are that children aged 10 - 18 years diagnosed with or having signs of
GER have higher DMFS (Decayed, Missing, Filled permanent tooth Surfaces) rates, higher SBI
(Sulcus Bleeding Index) rates, worse Periodontal status, and lower saliva buffering
capacity.
Status | Completed |
Enrollment | 79 |
Est. completion date | November 2008 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 9 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Ages 9.0 to 18.0 years, of either gender - Able to give verbal / written assent / consent themselves and/or informed consent from a parent/guardian - Willing to comply with all study procedures and protocols, - Willing to get dental photographs and impressions taken - Willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form Exclusion Criteria: - Subjects suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis) - Other conditions that may decrease the likelihood of adhering to study protocol, - Subjects who will leave the area and are unable to complete the study. |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco Dental School | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Takeda Pharmaceuticals North America, Inc. |
United States,
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