An interventional study of SRP + toothpaste + mouthwash and SRP + toothpaste in Dental Erosion, sponsored by University of Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-12.
Sponsored by University of Pavia · Not applicable, Interventional, and Treatment
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:
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).
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:
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).
47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.
This study's enrollment of 40 is above the median of 33 across 33 interventional studies indexed under Tooth Erosion.
Browse Tooth Erosion studies →University of Pavia is the lead sponsor of 144 studies on the registry; 39 are open to participants now.
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Exclusion Criteria:
SRP + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day
Other: SRP + toothpaste
SRP + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day
Other: SRP + toothpaste + mouthwash
Use of domiciliary products twice a day
Use of domiciliary products twice a day
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).
Time frame: 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; 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.
Time frame: 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; 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.
Time frame: 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.
Time frame: Study begin and after 15, 30 and 90 days.
Dental sensitivity
Assessment of dental sensitivity with a VAS scale (score: from 1 to 10)
Time frame: Study begin and after 15, 30 and 90 days.
Plan to share: No — Data will be available upon motivated request to Principal Investigator.
No publications or documents are linked to this record.
Ran from Dec 2021 to primary completion in Apr 2022, 4 months.
Of 20 interventional studies with no phase under Tooth Erosion, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 28. This study's 4 months is below that.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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