Gastroesophageal Reflux DiseaseNCT07108751
Association Between Gastroesophageal Reflux Disease (GERD) Severity and Dental Caries
An observational study of Gastroesophageal Reflux Disease and Severity, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to assess the relationship between gastroesophageal reflux disease (GERD) severity (based on upper gastrointestinal endoscopy) and dental caries severity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease, Severity, Dental Caries
- What is being tested?
- Endoscopy
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 18-65 years.
- Both sexes.
- Diagnosed with Gastroesophageal Reflux Disease (GERD) by endoscopy.
- Consent to participate.
Who cannot join
- Xerostomia-related disorders.
- Recent antibiotics (last 4 weeks).
- Head/neck radiation history.
- Cognitive impairment affecting consent.
- Pregnant or lactating women.
- HbA1c above 6.4%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Gastroesophageal Reflux Disease (GERD) Severity and Dental Caries: A Cross-Sectional Study
This study aimed to assess the relationship between gastroesophageal reflux disease (GERD) severity (based on upper gastrointestinal endoscopy) and dental caries severity.
Read the 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.
- Conditions
- Gastroesophageal Reflux Disease, Severity, Dental Caries
- Being tested
- Endoscopy
- Medical subject headings
- Gastroesophageal Reflux, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyDevice
Endoscopy will be performed to all patient
| Study group | Role | What they receive |
|---|---|---|
| Study group | Gastroesophageal reflux disease (GERD) patients. Receives: Device: Endoscopy | |
| Control group | Matched control group. Receives: Device: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-procedure
Secondary outcomes (3)
Basic Erosive Wear Examination Index
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).
Measured: 3 months post-procedure
Plaque Index
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.
Measured: 3 months post-procedure
Salivary analysis
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.
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Jan 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd El-Raouf Tawfik, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108751
- Sponsor's protocol ID
- 36264PR1280/7/25
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Gastroesophageal Reflux Disease (GERD) Severity and Dental Caries: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07108751
- Acronym / sponsor ID
- 36264PR1280/7/25
- Conditions
- Gastroesophageal Reflux Disease, Severity, Dental Caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: EndoscopyGastroesophageal reflux disease (GERD) patients. |
| Control group | – | Device: EndoscopyMatched control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age 18-65 years.
- Both sexes.
- Diagnosed with Gastroesophageal Reflux Disease (GERD) by endoscopy.
- Consent to participate.
Key exclusion criteria (6 listed)
- Xerostomia-related disorders.
- Recent antibiotics (last 4 weeks).
- Head/neck radiation history.
- Cognitive impairment affecting consent.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoscopyEndoscopy will be performed to all patient | Device | Control group, Study group |
Primary outcome
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.
3 secondary outcomes
Basic Erosive Wear Examination Index
Time frame: 3 months post-procedure
Plaque Index
Time frame: 3 months post-procedure
Salivary analysis
Time frame: 3 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Severity, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decayed, Missing, and Filled Teeth (DMFT) Index (time frame: 3 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.