Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01167543

Enrollment

Registered

2010-07-22

Start date

2005-09-30

Completion date

2008-11-30

Last updated

2010-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Erosion, Gastroesophageal Reflux

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

9 Years to 18 Years

Healthy volunteers

Yes

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.

Countries

United States

Outcome results