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Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease

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ClinicalTrials.gov Identifier: NCT01167543
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : July 22, 2010
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
University of California, San Francisco

Brief Summary:

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 or disease
Gastroesophageal Reflux Dental Erosion

Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Study Start Date : September 2005
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort
Pediatric patients with symptoms or diagnosis of GER
Control group of pediatric subjects with no symptoms of GER.




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.

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.

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 Posted: July 22, 2010    Key Record Dates
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