Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease

Completed

• Conditions: Gastroesophageal Reflux; Dental Erosion

• Registration Number: NCT01167543
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study Completion: 2008-11
• Status Verified: 2010-05
• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-21
• Last Update Submitted: 2010-07-21
• Study First Posted: 2010-07-22
• Last Update Posted: 2010-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of California, San Francisco Dental School; 🇺🇸 San Francisco, California, United States