---
title: Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease
nct_id: NCT01167543
overall_status: COMPLETED
sponsor: University of California, San Francisco
study_type: OBSERVATIONAL
primary_condition: Gastroesophageal Reflux
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01167543.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01167543"
ct_last_update_post_date: 2010-07-22
last_seen_at: "2026-05-12T07:34:28.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease

**NCT ID:** [NCT01167543](https://clinicaltrials.gov/study/NCT01167543)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 79
- **Lead Sponsor:** University of California, San Francisco
- **Collaborators:** Takeda Pharmaceuticals North America, Inc.
- **Conditions:** Gastroesophageal Reflux, Dental Erosion
- **Start Date:** 2005-09
- **Completion Date:** 2008-11
- **CT.gov Last Update:** 2010-07-22

## 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.

## Eligibility

- **Minimum age:** 9 Years
- **Maximum age:** 18 Years
- **Sex:** ALL
- **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.
```

## Arms

- **Pediatric patients with symptoms or diagnosis of GER**
- **Control group of pediatric subjects with no symptoms of GER.**

## Locations (1)

- University of California, San Francisco Dental School, San Francisco, California, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of california, san francisco dental school|san francisco|california|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01167543.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01167543*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*