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

NCT ID: NCT05371717

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-09-20

Brief Summary

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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, 6, 9 and 12 months from baseline.

Detailed Description

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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, 6, 9 and 12 months from baseline.

Conditions

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Gastro Esophageal Reflux Dental Erosion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Trial Group

Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment application

Group Type EXPERIMENTAL

Domiciliary use of Biorepair Total Protection + Biorepair Shock Treatment

Intervention Type OTHER

Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.

Control group

Domiciliary use of Biorepair Total Protection

Group Type ACTIVE_COMPARATOR

Biorepair Total Protection

Intervention Type OTHER

Domiciliary use of Biorepair Total Protection twice a day for oral hygiene + Biorepair Shock Treatment application for 10 min once a day.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, DDS, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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

Pavia, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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2022-GASTRO

Identifier Type: -

Identifier Source: org_study_id

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