NCT07108751

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 31, 2025

Last Update Submit

July 31, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Decayed, Missing, and Filled Teeth (DMFT) Index

    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.

    3 months post-procedure

Secondary Outcomes (3)

  • Basic Erosive Wear Examination Index

    3 months post-procedure

  • Plaque Index

    3 months post-procedure

  • Salivary analysis

    3 months post-procedure

Study Arms (2)

Study group

Gastroesophageal reflux disease (GERD) patients.

Device: Endoscopy

Control group

Matched control group.

Device: Endoscopy

Interventions

EndoscopyDEVICE

Endoscopy will be performed to all patient

Control groupStudy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A cross-sectional analytical study was conducted at the Gastrointestinal Endoscopy Unit of the Internal Medicine Department at Tanta University Hospital in Egypt, and the Outpatient Dental Clinic affiliated with Zarqa University Dental Clinics in Jordan between January and June 2025.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Gastroesophageal RefluxDental Caries

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesTooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 7, 2025

Study Start

January 1, 2025

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations