- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04595500
Relationship Between Gastroesophageal Reflux Disease and Dental Erosion
Gastroesophagial Reflux Disease as a Potential Contributor to Dental Erosions and Oral Tissue Alterations
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34500
- Fatma Aytac Bal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
Control
|
GERD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline
|
DMFT index
Time Frame: Baseline
|
The decayed, missing, and filled teeth index
|
Baseline
|
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.
|
Baseline
|
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.
|
Baseline
|
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).
|
Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Stomatognathic Diseases
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophagitis
- Peptic Ulcer
- Duodenal Diseases
- Tooth Diseases
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Tooth Wear
- Tooth Erosion
Other Study ID Numbers
- 131/2-2008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastroesophageal Reflux Disease
-
TakedaTerminatedGastroesophageal Reflux Disease | Non-erosive Reflux DiseaseSwitzerland, Netherlands
-
Vanderbilt University Medical CenterCompletedGastroesophageal Reflux Disease (GERD) | Non-erosive Reflux Disease (NERD)United States
-
Mansoura UniversityWithdrawnGastroesophageal Reflux Disease
-
Cliniques universitaires Saint-Luc- Université...UnknownGastroesophageal Reflux DiseaseBelgium
-
GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
-
King Chulalongkorn Memorial HospitalCompleted
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedGastroesophageal Reflux Disease | GERD | Acid Reflux | RefluxUnited States
-
PfizerTerminatedGastroesophageal Reflux DiseaseBrazil, Germany, Korea, Republic of, Belgium, Spain, Slovakia, France
-
GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedGastroesophageal Reflux Disease (GERD) | RefluxUnited States, Canada