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Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167543
First Posted: July 22, 2010
Last Update Posted: July 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
University of California, San Francisco
  Purpose

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.


Condition
Gastroesophageal Reflux Dental Erosion

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Enrollment: 79
Study Start Date: September 2005
Study Completion Date: November 2008
Groups/Cohorts
Pediatric patients with symptoms or diagnosis of GER
Control group of pediatric subjects with no symptoms of GER.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pediatric Specialty Clinics and General Pediatric Clinics at the University of California, San Francisco
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167543


Locations
United States, California
University of California, San Francisco Dental School
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Takeda Pharmaceuticals North America, Inc.
  More Information

Responsible Party: Melvin B. Heyman MD MPH, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01167543     History of Changes
Other Study ID Numbers: MA-L-017
First Submitted: July 20, 2010
First Posted: July 22, 2010
Last Update Posted: July 22, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Gastroesophageal Reflux
Tooth Erosion
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Tooth Wear
Tooth Diseases
Stomatognathic Diseases