A New Protocol for the Management of Dental Erosion in Rugby Players

NCT ID: NCT05140538

Last Updated: 2022-05-12

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-18

Study Completion Date

2022-05-01

Brief Summary

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The aim of the present study is to provide a new domiciliary oral care treatment for enamel remineralization in rugby players patients using mouthguards. Patients selected for the study will be randomly divided and allocated in two groups according to the treatment:

* Group 1: scaling and root planing (SRP) + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day
* Group 2: scaling and root planing (SRP) + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day

Patients will be given instructions for the cleaning of their mouthguards. The periodontal evaluation will be conducted before SRP, after 15, 30 and 90 days. The periodontal indices collected will be: PI, BoP, Schiff Air Index, BEWE index and dental sensitivity (VAS scale).

Detailed Description

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The aim of the present study is to provide a new domiciliary oral care treatment for enamel remineralization in rugby players patients using mouthguards and to prevent further worsening of dental erosion. Patients selected for the study will sign the informed consent and will be randomly divided and allocated into two groups:

* Group 1: SRP + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day
* Group 2: SRP + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day

Patients will be given instructions for the cleaning of their mouthguards. The periodontal evaluation will be conducted before SRP, after 15, 30 and 90 days. The periodontal indices collected will be: PI, BoP, Schiff Air Index, BEWE index and dental sensitivity (VAS scale).

Conditions

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Dental Erosion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1

SRP + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day

Group Type ACTIVE_COMPARATOR

SRP + toothpaste

Intervention Type OTHER

Use of domiciliary products twice a day

Group 2

SRP + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day

Group Type EXPERIMENTAL

SRP + toothpaste + mouthwash

Intervention Type OTHER

Use of domiciliary products twice a day

Interventions

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SRP + toothpaste + mouthwash

Use of domiciliary products twice a day

Intervention Type OTHER

SRP + toothpaste

Use of domiciliary products twice a day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients willing to participate to the study
* Rugby players

Exclusion Criteria

* Patients with cardiac pacemaker
* Patients suffering from neurological disorders
* Patients suffering from psychological disorders
* Pregnant or breastfeeding women
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Research Resident, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, DDS, PhD

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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2021-RUGBY

Identifier Type: -

Identifier Source: org_study_id

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