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Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT01167543
Collaborator
Takeda Pharmaceuticals North America, Inc. (Industry)
79
Enrollment
1
Location
38
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    79 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Study Start Date :
    Sep 1, 2005
    Actual Study Completion Date :
    Nov 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    Pediatric patients with symptoms or diagnosis of GER
    Control group of pediatric subjects with no symptoms of GER.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      9 Years to 18 Years
      Sexes Eligible for Study:
      All
      Accepts 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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University of California, San Francisco Dental School San Francisco California United States 94143

      Sponsors and Collaborators

      • University of California, San Francisco
      • Takeda Pharmaceuticals North America, Inc.

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01167543
      Other Study ID Numbers:
      • MA-L-017
      First Posted:
      Jul 22, 2010
      Last Update Posted:
      Jul 22, 2010
      Last Verified:
      May 1, 2010
      Additional relevant MeSH terms:
      Gastroesophageal Reflux
      Esophagitis, Peptic
      Tooth Erosion

      Study Results

      No Results Posted as of Jul 22, 2010