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CompletedNCT01167543Updated Jul 22, 2010

Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease

An observational study in Gastroesophageal Reflux and Dental Erosion, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 9 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-07-22.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
79
Ages
9 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastroesophageal Reflux
  • Dental Erosion
03

In context

Gastroesophageal Reflux

1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.

This study's enrollment of 79 is below the median of 178 across 348 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pediatric Specialty Clinics and General Pediatric Clinics at the University of California, San Francisco

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ages 9.0 to 18.0 years, of either gender
  • Able to give verbal / written assent / consent themselves and/or 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

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, , 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
79 participants (actual)

Groups and cohorts

  • Pediatric patients with symptoms or diagnosis of GER
  • Control group of pediatric subjects with no symptoms of GER.
06

Study locations

1 site
  • University of California, San Francisco Dental School
    San Francisco, California 94143, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01167543
Collaborators
Takeda Pharmaceuticals North America, Inc.
First posted
Jul 22, 2010
Start date
Sep 2005
Completion
Nov 2008
Last update
Jul 22, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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