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

Primary Purpose

Dental Erosion

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
SRP + toothpaste + mouthwash
SRP + toothpaste
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Erosion focused on measuring enamel remineralization

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in BOP - Bleeding on Probing (percentage)
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 4 sites (mesial, distal, vestibular, palatal/lingual).
Change in Schiff Air Index - Dental sensitivity test
Scoring criteria: 0: the subject did not respond to air blasting; the subject responded to air blasting; the subject responded to air blasting and requested discontinuation; the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.
Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)
Scoring criteria: 0: no erosive tooth wear; initial loss of surface texture; distinct defect, hard tissue loss < 50% of the surface area; hard tissue loss ≥ 50% of the surface area.
Change in PI - Plaque Index (percentage)
Evaluation of the presence of plaque with a disclosing agent on the 4 surfaces of teeth on the total amount of dental surfaces multiplied per 100.
Dental sensitivity
Assessment of dental sensitivity with a VAS scale (score: from 1 to 10)

Secondary Outcome Measures

Full Information

First Posted
November 18, 2021
Last Updated
May 11, 2022
Sponsor
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT05140538
Brief Title
A New Protocol for the Management of Dental Erosion in Rugby Players
Official Title
A New Domiciliary Oral Care Protocol for the Management of Dental Erosion in Rugby Players: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2021 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Erosion
Keywords
enamel remineralization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
SRP + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day
Arm Title
Group 2
Arm Type
Experimental
Arm Description
SRP + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day
Intervention Type
Other
Intervention Name(s)
SRP + toothpaste + mouthwash
Intervention Description
Use of domiciliary products twice a day
Intervention Type
Other
Intervention Name(s)
SRP + toothpaste
Intervention Description
Use of domiciliary products twice a day
Primary Outcome Measure Information:
Title
Change in BOP - Bleeding on Probing (percentage)
Description
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 4 sites (mesial, distal, vestibular, palatal/lingual).
Time Frame
Study begin, 1 and 3 months
Title
Change in Schiff Air Index - Dental sensitivity test
Description
Scoring criteria: 0: the subject did not respond to air blasting; the subject responded to air blasting; the subject responded to air blasting and requested discontinuation; the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.
Time Frame
Study begin and after 15, 30 and 90 days.
Title
Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)
Description
Scoring criteria: 0: no erosive tooth wear; initial loss of surface texture; distinct defect, hard tissue loss < 50% of the surface area; hard tissue loss ≥ 50% of the surface area.
Time Frame
Study begin and after 15, 30 and 90 days.
Title
Change in PI - Plaque Index (percentage)
Description
Evaluation of the presence of plaque with a disclosing agent on the 4 surfaces of teeth on the total amount of dental surfaces multiplied per 100.
Time Frame
Study begin and after 15, 30 and 90 days.
Title
Dental sensitivity
Description
Assessment of dental sensitivity with a VAS scale (score: from 1 to 10)
Time Frame
Study begin and after 15, 30 and 90 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Scribante, DDS, PhD
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
City
Pavia
State/Province
Lombardy
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon motivated request to Principal Investigator.

Learn more about this trial

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

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