CompletedNot Applicable

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

Italy40 participantsStarted 2021-12-18

Plain-language 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).

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in BOP - Bleeding on Probing (percentage)

Timeframe: Study begin, 1 and 3 months

Change in Schiff Air Index - Dental sensitivity test

Timeframe: Study begin and after 15, 30 and 90 days.

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

Timeframe: Study begin and after 15, 30 and 90 days.

Change in PI - Plaque Index (percentage)

Timeframe: Study begin and after 15, 30 and 90 days.

Dental sensitivity

Timeframe: Study begin and after 15, 30 and 90 days.

Trial details

NCT IDNCT05140538

SponsorUniversity of Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-27

View on ClinicalTrials.gov More Dental Erosion trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in BOP - Bleeding on Probing (percentage)

Timeframe: Study begin, 1 and 3 months

Change in Schiff Air Index - Dental sensitivity test

Timeframe: Study begin and after 15, 30 and 90 days.

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

Timeframe: Study begin and after 15, 30 and 90 days.

Change in PI - Plaque Index (percentage)

Timeframe: Study begin and after 15, 30 and 90 days.

Dental sensitivity

Timeframe: Study begin and after 15, 30 and 90 days.