Clinical trial NCT05140538: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Erosion
Keywords: enamel remineralization
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in BOP - Bleeding on Probing (percentage)
timeFrame: Study begin, 1 and 3 months
measure: Change in Schiff Air Index - Dental sensitivity test
timeFrame: Study begin and after 15, 30 and 90 days.
measure: Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)
timeFrame: Study begin and after 15, 30 and 90 days.
measure: Change in PI - Plaque Index (percentage)
timeFrame: Study begin and after 15, 30 and 90 days.
measure: Dental sensitivity
timeFrame: Study begin and after 15, 30 and 90 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: