Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease

NCT ID: NCT01167543

Last Updated: 2010-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 79 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2008-11-30

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 Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Pediatric patients with symptoms or diagnosis of GER

No interventions assigned to this group

Control group of pediatric subjects with no symptoms of GER.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

University of California, San Francisco

Locations

University of California, San Francisco Dental School

San Francisco, California, United States

Countries

United States

Other Identifiers

MA-L-017

Identifier Type: -

Identifier Source: org_study_id