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

Study Overview
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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).

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

Conditions
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Dental Erosion

Intervention / Treatment
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* Other: SRP + toothpaste + mouthwash
* Other: SRP + toothpaste


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>SRP + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day | Other: SRP + toothpaste<br>* Use of domiciliary products twice a day<br>|
| Experimental: Group 2<br>SRP + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day | Other: SRP + toothpaste + mouthwash<br>* Use of domiciliary products twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Study begin, 1 and 3 months | 
| 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. | Study begin and after 15, 30 and 90 days. | 
| 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. | Study begin and after 15, 30 and 90 days. | 
| 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. | Study begin and after 15, 30 and 90 days. | 
| Dental sensitivity | Assessment of dental sensitivity with a VAS scale (score: from 1 to 10) | Study begin and after 15, 30 and 90 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enamel remineralization