Domiciliary Management of Dental Erosion in Patients With GERD With Biomimetic Hydroxyapatite

February 18, 2024 updated by: Andrea Scribante, University of Pavia

Management of Dental Erosion in Patients With Gastroesophageal Reflux Disease With Biomimetic Hydroxyapatite Toothpaste

The aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (GERD).

Patients consenting to participate to the study will undergo periodontal evaluation at the baseline. Then, professional dental hygiene will be performed. Patients will be randomly assigned to:

  • Trial group: home oral hygiene with Biorepair Total Protection + Biorepair Shock Treatment twice a day
  • Control group: home oral hygiene with Biorepair Total Protection Patients will be evaluated after 1, 3 and 6 months from baseline.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (GERD).

Patients consenting to participate to the study will undergo periodontal evaluation at the baseline. Then, professional dental hygiene will be performed. Patients will be randomly assigned to:

  • Trial group: home oral hygiene with Biorepair Total Protection + Biorepair Shock Treatment twice a day
  • Control group: home oral hygiene with Biorepair Total Protection Patients will be evaluated after 1, 3 and 6 months from baselin

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with dental erosion
  • no proton pumps before pH examination

Exclusion Criteria:

  • no dental erosion
  • neurological and psychiatric diseases;
  • pregnant and/or breastfeeding women;
  • patients with poor compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trial Group
Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment application
Other: Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment
Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.
Active Comparator: Control group
Domiciliary use of Biorepair Total Protection
Other: Biorepair Total Protection
Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of BEWE (Basic Erosive Wear Examination)
Time Frame: Study begin, 1, 3 and 6 months after the baseline

Scoring criteria (Barlet et al., 2008):

  • 0: no erosive tooth wear;
  • 1: initial loss of surface texture;
  • 2: distinct defect, hard tissue loss < 50% of the surface area;
  • 3: hard tissue loss ≥ 50% of the surface area.

IntactTooth smartphone application will be used to calculate this index.
Study begin, 1, 3 and 6 months after the baseline
Change in Schiff Air Index - Dental sensitivity test
Time Frame: Study begin, 1, 3 and 6 months after the baseline

Scoring criteria:

0: the subject did not respond to air blasting;

  1. the subject responded to air blasting;
  2. the subject responded to air blasting and requested discontinuation;
  3. the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.
Study begin, 1, 3 and 6 months after the baseline
Change in Plaque Index (PI% - O' Leary Index)
Time Frame: Study begin, 1, 3 and 6 months after the baseline

Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.

Formula = n ° sites with plaque / total n ° of dental surfaces x100
Study begin, 1, 3 and 6 months after the baseline
Change in Bleeding Score (BS - Mombelli et al.)
Time Frame: Study begin, 1, 3 and 6 months after the baseline

Scoring criteria:

0: no bleeding

  1. isolated visible spots
  2. blood forms a confluent red line on the mucosal margin
  3. profuse and copious bleeding
Study begin, 1, 3 and 6 months after the baseline
Laryngopharyngeal pH monitoring pH monitoring
Time Frame: Study begin, 1, 3 and 6 months after the baseline
Data was collected wirelessly for 24 hours and then analysed. Length, severity and number of reflux episodes were calculated. The RYAN score was used to evaluate for laryngopharyngeal acid reflux and was calculated for both the upright and supine positions. A RYAN score >9.4 in the upright position or >6.8 in the supine position was considered positive. Patients with a positive RYAN score in either the upright or supine positions were considered positive for laryngopharyngeal acid reflux.
Study begin, 1, 3 and 6 months after the baseline
Erosion risk level
Time Frame: Study begin, 1, 3 and 6 months after the baseline

For each sextant, the highest BEWE value will be chosen. A mean of all the sextant values will be performed to calculate erosion risk level.

IntactTooth smartphone application will be used to calculate this index.
Study begin, 1, 3 and 6 months after the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Investigators

  • Principal Investigator: Andrea Scribante, DDS, PhD, MS, University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

May 17, 2024

Study Completion (Estimated)

May 20, 2024

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

May 7, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-GASTRO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon motivated request to the Principal Investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 Gastro Esophageal Reflux

Clinical Trials on Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe