NCT04595500

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

October 14, 2020

Last Update Submit

October 19, 2020

Conditions

Keywords

Dental erosionDMFTGastroesophageal Reflux DiseaseSaliva

Outcome Measures

Primary Outcomes (6)

  • 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

  • DMFT index

    The decayed, missing, and filled teeth index

    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.

    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.

    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).

    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.

    Baseline

Study Arms (2)

GERD

Control

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma Aytac Bal

Istanbul, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gastroesophageal RefluxTooth WearTooth Erosion

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesTooth DiseasesStomatognathic DiseasesTooth Demineralization

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 14, 2020

First Posted

October 20, 2020

Study Start

January 1, 2009

Primary Completion

February 1, 2010

Study Completion

March 1, 2011

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

Locations