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

A New Domiciliary Oral Care Protocol for the Management of Dental Erosion in Rugby Players: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05140538
Enrollment
40
Registered
2021-12-01
Start date
2021-12-18
Completion date
2022-05-01
Last updated
2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Erosion

Keywords

enamel remineralization

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).

Interventions

OTHERSRP + toothpaste + mouthwash

Use of domiciliary products twice a day

OTHERSRP + toothpaste

Use of domiciliary products twice a day

Sponsors

University of Pavia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in BOP - Bleeding on Probing (percentage)Study begin, 1 and 3 monthsSite-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 testStudy begin and after 15, 30 and 90 days.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.
Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)Study begin and after 15, 30 and 90 days.Scoring criteria: 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.
Change in PI - Plaque Index (percentage)Study begin and after 15, 30 and 90 days.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 sensitivityStudy begin and after 15, 30 and 90 days.Assessment of dental sensitivity with a VAS scale (score: from 1 to 10)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026