Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease

Gastroesophageal Reflux Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167543
• Other study ID #: MA-L-017
• Status: Completed
• Phase: N/A
• First received: July 20, 2010
• Last updated: July 21, 2010
• Start date: September 2005
• Est. completion date: November 2008

Study information

• Verified date: May 2010
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 18 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dental Erosion
• Gastroesophageal Reflux
• Tooth Erosion

Locations

Country	Name	City	State
United States	University of California, San Francisco Dental School	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States,