Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease
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Purpose
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.
| Condition |
|---|
|
Gastroesophageal Reflux Dental Erosion |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Enrollment: | 79 |
| Study Start Date: | September 2005 |
| Study Completion Date: | November 2008 |
| Groups/Cohorts |
|---|
| Pediatric patients with symptoms or diagnosis of GER |
| Control group of pediatric subjects with no symptoms of GER. |
Eligibility| Ages Eligible for Study: | 9 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Pediatric Specialty Clinics and General Pediatric Clinics at the University of California, San Francisco
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.
Contacts and Locations| United States, California | |
| University of California, San Francisco Dental School | |
| San Francisco, California, United States, 94143 | |
More Information
No publications provided
| Responsible Party: | Melvin B. Heyman MD MPH, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01167543 History of Changes |
| Other Study ID Numbers: | MA-L-017 |
| Study First Received: | July 20, 2010 |
| Last Updated: | July 21, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Periodontal Diseases Tooth Erosion Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases |
Gastrointestinal Diseases Digestive System Diseases Mouth Diseases Stomatognathic Diseases Tooth Wear Tooth Diseases |
ClinicalTrials.gov processed this record on June 18, 2013