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

Dental Erosion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05140538
• Other study ID #: 2021-RUGBY
• Status: Completed
• Phase: N/A
• Start date: December 18, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 1, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Erosion
• Tooth Erosion

Intervention

Other:
• SRP + toothpaste + mouthwash
Use of domiciliary products twice a day
• SRP + toothpaste
Use of domiciliary products twice a day

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	Dental sensitivity	Assessment of dental sensitivity with a VAS scale (score: from 1 to 10)	Study begin and after 15, 30 and 90 days.