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OpenTrials
Completed

NCT Number: NCT01167543

Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease

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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Dental Erosion Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Stomatognathic Diseases Tooth Demineralization Tooth Diseases Tooth Erosion Tooth Wear

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco Dental School

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Takeda Pharmaceuticals North America, Inc.

Registry information

Important dates

Study start
2005
Study completion
2008
First posted
Jul 22, 2010
Registry last updated
Jul 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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