Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease

NCT01167543 | Completed

• 1 other identifier: MA-L-017
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux; Dental Erosion

Study Arms (2)

Pediatric patients with symptoms or diagnosis of GER

Control group of pediatric subjects with no symptoms of GER.

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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 & Collaborators

• University of California, San Francisco: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

University of California, San Francisco Dental School

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Tooth Erosion

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 22, 2010
• Study Start: September 1, 2005
• Study Completion: November 1, 2008
• Last Updated: July 22, 2010

Record last verified: 2010-05

Locations

US (1)