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

NCT05140538 | Completed

• 1 other identifier: 2021-RUGBY
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Erosion

Keywords

enamel remineralization

Outcome Measures

Primary Outcomes (5)

• 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; 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.

  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.

  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.

Study Arms (2)

Group 1

ACTIVE COMPARATOR

SRP + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day

Other: SRP + toothpaste

Group 2

EXPERIMENTAL

SRP + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day

Other: SRP + toothpaste + mouthwash

Interventions

SRP + toothpaste + mouthwash OTHER

Use of domiciliary products twice a day

Group 2

SRP + toothpaste OTHER

Use of domiciliary products twice a day

Group 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients willing to participate to the study
• Rugby players

You may not qualify if:

• Patients with cardiac pacemaker
• Patients suffering from neurological disorders
• Patients suffering from psychological disorders
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Tooth Erosion

Interventions

Toothpastes; Mouthwashes

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Resident, Principal Investigator

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: December 18, 2021
• Primary Completion: April 27, 2022
• Study Completion: May 1, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)