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.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux; Dental Erosion

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric Specialty Clinics and General Pediatric Clinics at the University of California, San Francisco

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Takeda Pharmaceuticals North America, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: July 20, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (Estimate): July 22, 2010

Study Record Updates

• Last Update Posted (Estimate): July 22, 2010
• Last Update Submitted That Met QC Criteria: July 21, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Stomatognathic Diseases; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Tooth Diseases; Tooth Wear; Gastroesophageal Reflux; Esophagitis, Peptic; Tooth Erosion
• Other Study ID Numbers: MA-L-017