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

Completed

• Conditions: Gastroesophageal Reflux Disease; Severity; Dental Caries

• Registration Number: NCT07108751
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2025-01-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-07-31
• Last Update Submitted: 2025-07-31
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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%.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decayed, Missing, and Filled Teeth (DMFT) Index	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 Outcome Measures

Name	Time	Method
Basic Erosive Wear Examination Index	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).
Plaque Index	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.
Salivary analysis	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt