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CompletedNCT04595500Updated Oct 20, 2020

Relationship Between Gastroesophageal Reflux Disease and Dental Erosion

An observational study in Gastroesophageal Reflux Disease and Tooth Wear, sponsored by University of Beykent. Completed at 1 site in Turkey. Open to participants aged 16 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-20.

Sponsored by University of Beykent · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
100
Ages
16 Years to 65 Years
Sex
All
01

Study summary

This study aimed to investigate the relationship between gastroesophageal reflux disease (GERD) and dental erosion and the alterations in oral tissues. This was a case-control study. The GERD group consisted of 50 individuals with endoscopic esophagitis who had gastroesophageal reflux symptoms, and the control group consisted of 50 healthy individuals. The prevalence of teeth wear and caries was evaluated using the Smith and Knight tooth wear index (TWI) and the decayed, missing, and filled teeth index (DMFT), respectively. Inflammatory mouth sensitivity, tongue sensitivity, nonspecific itching and burning, halitosis, dry mouth, teeth sensitivity, and the erythema of the soft and hard palatal mucosa and uvula were also evaluated. Stimulated saliva samples were collected, and the salivary flow rate, pH, and buffering capacity values were measured.

02

Conditions studied

  • Gastroesophageal Reflux Disease
  • Tooth Wear

Keywords

  • Dental erosion
  • DMFT
  • Gastroesophageal Reflux Disease
  • Saliva
03

In context

Gastroesophageal Reflux

1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.

This study's enrollment of 100 is below the median of 178 across 348 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

University of Beykent is the lead sponsor of 56 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

This case-control study was conducted in Ankara University Faculty of Dentistry, Department of Restorative Dentistry Polyclinics and Ankara University Faculty of Medicine, Department of Gastroenterology Polyclinics with a total of 100 participants (49 females and 51 males between the ages of 16-65) of whom 50 were in the GERD group, and 50 were in the control group. Among the patients who were admitted to the clinics, those with a diagnosis of GERD were included in the patient group and those without GERD were included in the control group. Ethical approval of the study protocol was granted by the Ankara University Faculty of Dentistry Research Ethics Committee (No:131/2 Date:10.06.2008).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The patient group included with at least one year of reflux symptoms, endoscopic esophagitis, no systemic disease other than reflux, no medication use except anti-reflux drugs, no habit of ruminating and vomiting, and no habit of bruxism.
  • The control group included without any systemic disorder, no habit of ruminant and vomiting, no habit of bruxism, and no drug use.

Exclusion criteria

Exclusion Criteria:

  • The volunteers who were vegetarian, consumed citrus and vinegar frequently, and consumed more than ½ liter of acidic beverages per day were not included in the study. Those who never brush their teeth and were using battery/rechargeable and scrub brush and abrasive toothpaste were not included in the study, either.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • GERD
  • Control
06

What researchers measure

Primary outcomes

  1. TWI (Smith and Knight tooth wear index)

    Score 0 No loss of enamel surface characteristics. No loss of contour. Score 1 Loss of enamel surface characteristics. Minimal loss of contour. Score 2 Loss of enamel exposing dentine for less than one third of surface. Loss of enamel just exposing dentine. Defect less than 1 mm deep. Score 3 Loss of enamel exposing dentine for more than one third of surface. Loss of enamel and substantial loss of dentine. Defect less than 1-2 mm deep. Score 4 Complete enamel loss - pulp exposure - secondary dentin exposure. Pulp exposure or exposure of secondary dentine. Defect more than 2mm deep - pulp exposure - secondary dentine exposure.

    Time frame: Baseline

  2. DMFT index

    The decayed, missing, and filled teeth index

    Time frame: Baseline

  3. Salivary flow rate

    Saliva collection was performed between 9:00 and 12:00 in the morning. Stimulation for the collection of saliva samples was provided by sugar-free gum. Saliva flow rate was recorded as ml / min by dividing the amount obtained after 5 minutes of chewing by the time.

    Time frame: Baseline

  4. pH value

    The pH value of saliva samples was measured with a pH meter (Sentron digital pH-meter, Nisan Inc.,Turkey). The calibration procedure of the device was done in accordance with the manufacturer's instructions and using standard pH buffers.

    Time frame: Baseline

  5. Buffering capacity

    The buffering capacity of the collected saliva samples was determined according to the Ericsson method.The collected stimulated saliva was taken into another sterile glass tube by drawing 1 ml without waiting. 3ml 0.005 N HCl was added onto it and the vessel was vibrated slightly to remove carbon dioxide and the pH value was measured with a pH meter (Sentron digital pH-meter, Nisan Inc.,Turkey).

    Time frame: Baseline

  6. Oral complaints

    Oral complaints of the participants were evaluated according to the answers given to the questions regarding inflammatory mouth sensitivity, tongue sensitivity, nonspecific itching and burning in the mucosa, halitosis, dry mouth, and increased teeth sensitivity. The presence of erythema in the soft/hard palatal mucosa/uvula was determined by oral examination.

    Time frame: Baseline

07

Study locations

1 site
  • Fatma Aytac Bal
    Istanbul, 34500, Turkey
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2009 to primary completion in Feb 2010, 13 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2020
First posted
Oct 20, 2020
StartActual
Jan 2009
Primary completionActual
Feb 2010
CompletionActual
Mar 2011
Last update
Oct 20, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04595500
Lead sponsor
University of Beykent
Collaborators
Ankara University
Responsible party
Fatma AYTAC BAL (Assistant professor, University of Beykent) — Principal investigator
First posted
Oct 20, 2020
Start date
Jan 2009
Primary completion
Feb 2010
Completion
Mar 2011
Last update
Oct 20, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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