Gastroesophageal Reflux Disease Clinical Trial
Official title:
Gastroesophagial Reflux Disease as a Potential Contributor to Dental Erosions and Oral Tissue Alterations
NCT number | NCT04595500 |
Other study ID # | 131/2-2008 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2009 |
Est. completion date | March 2011 |
Verified date | October 2020 |
Source | University of Beykent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 2011 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Fatma Aytac Bal | Istanbul |
Lead Sponsor | Collaborator |
---|---|
University of Beykent | Ankara University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Baseline | |
Primary | DMFT index | The decayed, missing, and filled teeth index | Baseline | |
Primary | 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. | Baseline | |
Primary | 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. | Baseline | |
Primary | 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). | Baseline | |
Primary | 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. | Baseline |
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