CompletedNot Applicable

Domiciliary Management of Dental Erosion in Patients With GERD With Biomimetic Hydroxyapatite

Italy30 participantsStarted 2022-05-01

Plain-language summary

The aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (GERD). Patients consenting to participate to the study will undergo periodontal evaluation at the baseline. Then, professional dental hygiene will be performed. Patients will be randomly assigned to: * Trial group: home oral hygiene with Biorepair Total Protection + Biorepair Shock Treatment twice a day * Control group: home oral hygiene with Biorepair Total Protection Patients will be evaluated after 1, 3, 6, 9 and 12 months from baseline.

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 with dental erosion * no proton pumps before pH examination Exclusion Criteria: * no dental erosion * neurological and psychiatric diseases; * pregnant and/or breastfeeding women; * patients with poor compliance.

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 of BEWE (Basic Erosive Wear Examination)

Timeframe: Study begin, 1, 3, 6, 9 and 12 months after the baseline

Change in Schiff Air Index - Dental sensitivity test

Timeframe: Study begin, 1, 3, 6, 9 and 12 months after the baseline

Change in Plaque Index (PI% - O' Leary Index)

Timeframe: Study begin, 1, 3, 6, 9 and 12 months after the baseline

Change in Bleeding Score (BS - Mombelli et al.)

Timeframe: Study begin, 1, 3, 6, 9 and 12 months after the baseline

Laryngopharyngeal pH monitoring

Timeframe: Study begin, 1, 3, 6, 9 and 12 months after the baseline

Erosion risk level

Timeframe: Study begin, 1, 3, 6, 9 and 12 months after the baseline

Trial details

NCT IDNCT05371717

SponsorUniversity of Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-17

View on ClinicalTrials.gov More Gastro Esophageal Reflux 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 of BEWE (Basic Erosive Wear Examination)

Timeframe: Study begin, 1, 3, 6, 9 and 12 months after the baseline

Change in Schiff Air Index - Dental sensitivity test

Timeframe: Study begin, 1, 3, 6, 9 and 12 months after the baseline

Change in Plaque Index (PI% - O' Leary Index)

Timeframe: Study begin, 1, 3, 6, 9 and 12 months after the baseline

Change in Bleeding Score (BS - Mombelli et al.)

Timeframe: Study begin, 1, 3, 6, 9 and 12 months after the baseline

Laryngopharyngeal pH monitoring

Timeframe: Study begin, 1, 3, 6, 9 and 12 months after the baseline

Erosion risk level

Timeframe: Study begin, 1, 3, 6, 9 and 12 months after the baseline