A New Protocol for the Management of Dental Erosion in Rugby Players
- Conditions
- Dental Erosion
- Interventions
- Other: SRP + toothpasteOther: SRP + toothpaste + mouthwash
- Registration Number
- NCT05140538
- Lead Sponsor
- University of Pavia
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Patients willing to participate to the study
- Rugby players
- Patients with cardiac pacemaker
- Patients suffering from neurological disorders
- Patients suffering from psychological disorders
- Pregnant or breastfeeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 SRP + toothpaste SRP + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day Group 2 SRP + toothpaste + mouthwash SRP + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day
- Primary Outcome Measures
Name Time Method Change in BOP - Bleeding on Probing (percentage) Study begin, 1 and 3 months 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 Study 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 sensitivity Study begin and after 15, 30 and 90 days. Assessment of dental sensitivity with a VAS scale (score: from 1 to 10)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
🇮🇹Pavia, Lombardy, Italy