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NCT Number: NCT05140538

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

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).

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Key information

Conditions

Dental Erosion Stomatognathic Diseases Tooth Demineralization Tooth Diseases Tooth Erosion Tooth Wear

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SRP + toothpaste + mouthwash

Other

Use of domiciliary products twice a day

SRP + toothpaste

Other

Use of domiciliary products twice a day

Primary outcomes

  1. Change in BOP - Bleeding on Probing (percentage)

    Time frame: 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).

  2. Change in Schiff Air Index - Dental sensitivity test

    Time frame: Study begin and after 15, 30 and 90 days.

    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.

  3. Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)

    Time frame: Study begin and after 15, 30 and 90 days.

    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.

  4. Change in PI - Plaque Index (percentage)

    Time frame: 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.

  5. Dental sensitivity

    Time frame: Study begin and after 15, 30 and 90 days.

    Assessment of dental sensitivity with a VAS scale (score: from 1 to 10)

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2021
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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