Gastroesophageal Reflux DiseaseNCT04595500
Relationship Between Gastroesophageal Reflux Disease and Dental Erosion
An observational study of Gastroesophageal Reflux Disease and Tooth Wear, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease, Tooth Wear
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2009to Mar 2011
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastroesophagial Reflux Disease as a Potential Contributor to Dental Erosions and Oral Tissue Alterations
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.
- Conditions
- Gastroesophageal Reflux Disease, Tooth Wear
- Keywords
- Dental erosion, DMFT, Gastroesophageal Reflux Disease, Saliva
- Medical subject headings
- Gastroesophageal Reflux, Tooth Wear, Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GERD | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
DMFT index
The decayed, missing, and filled teeth index
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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).
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study startJan 2009
- Primary completionFeb 2010
- Study completionMar 2011
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.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Responsible party
- Principal investigator, Fatma AYTAC BAL, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595500
- Sponsor's protocol ID
- 131/2-2008
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroesophagial Reflux Disease as a Potential Contributor to Dental Erosions and Oral Tissue Alterations
- ClinicalTrials.gov ID
- NCT04595500
- Acronym / sponsor ID
- 131/2-2008
- Conditions
- Gastroesophageal Reflux Disease, Tooth Wear
- Keywords
- Dental erosion, DMFT, Gastroesophageal Reflux Disease, Saliva
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- Jan 2009 (actual)
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 20 Oct 2020 (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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GERD | – | – |
| Control | – | – |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TWI (Smith and Knight tooth wear index)
Time frame: Baseline
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.
DMFT index
Time frame: Baseline
The decayed, missing, and filled teeth index
Salivary flow rate
Time frame: Baseline
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.
pH value
Time frame: Baseline
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.
Buffering capacity
Time frame: Baseline
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).
Oral complaints
Time frame: Baseline
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.
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 20 Oct 2020.
- Individual participant dataSharing planned: Yes
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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 Tooth Wear, run by University of Beykent at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 20 Oct 2020. 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 Turkey (Türkiye). 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?
TWI (Smith and Knight tooth wear index) (time frame: Baseline). The study lists 6 primary outcomes in all. 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 20 Oct 2020.