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Completed

NCT Number: NCT07108751

Association Between Gastroesophageal Reflux Disease (GERD) Severity and Dental Caries

This study aimed to assess the relationship between gastroesophageal reflux disease (GERD) severity (based on upper gastrointestinal endoscopy) and dental caries severity.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Dental Caries Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Severity Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

Gastroesophageal reflux disease (GERD) is a chronic condition characterized by reflux of stomach acid into the esophagus, with a prevalence reaching 20-30% in many populations. Beyond its gastrointestinal manifestations, GERD may have extraesophageal effects, including oral health disturbances such as dental erosion and caries. Exposure of the oral cavity to gastric acid, especially in patients with severe or nocturnal reflux, may contribute to enamel demineralization, increased tooth decay, and lower salivary pH.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65 years.
  • Both sexes.
  • Diagnosed with Gastroesophageal Reflux Disease (GERD) by endoscopy.
  • Consent to participate.

Exclusion criteria

  • Xerostomia-related disorders.
  • Recent antibiotics (last 4 weeks).
  • Head/neck radiation history.
  • Cognitive impairment affecting consent.
  • Pregnant or lactating women.
  • HbA1c above 6.4%.

Treatment and study plan

Endoscopy

Device

Endoscopy will be performed to all patient

Primary outcomes

  1. Decayed, Missing, and Filled Teeth (DMFT) Index

    Time frame: 3 months post-procedure

    The Decayed, Missing, and Filled Teeth (DMFT) Index was calculated as the sum of decayed, missing, and filled teeth, with scores ranging from 0 to 28 or 32, depending on the total number of teeth present.

Secondary outcomes

  1. Basic Erosive Wear Examination Index

    Time frame: 3 months post-procedure

    The Basic Erosive Wear Examination Index was used to evaluate tooth surface erosion, with each of the six oral sextants scored based on the most severely affected tooth surface. Erosive wear was graded from 0 (no erosive wear) to 3 (hard tissue loss of 50 percent or greater of the surface area), with cumulative scores categorized into risk bands ranging from no risk (0-2) to high risk (≥14).

  2. Plaque Index

    Time frame: 3 months post-procedure

    The Plaque Index was assessed by examining four surfaces per tooth (buccal, lingual, mesial, and distal) and scoring plaque thickness from 0 (no plaque) to 3 (heavy plaque accumulation), with final scores calculated as the total plaque scores divided by the number of surfaces examined.

  3. Salivary analysis

    Time frame: 3 months post-procedure

    Saliva was accumulated in the mouth without stimulation and expectorated into sterile tubes every 60 seconds for five minutes. Salivary pH was measured immediately using a calibrated digital pH meter with measurements taken for 1-2 seconds in 1-2 mL samples.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Association Between Gastroesophageal Reflux Disease (GERD) Severity and Dental Caries: A Cross-Sectional Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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