Dental ErosionNCT05140538
A New Protocol for the Management of Dental Erosion in Rugby Players
A study testing SRP + toothpaste + mouthwash and SRP + toothpaste in people with Dental Erosion, run by University of Pavia at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Erosion
- What is being tested?
- SRP + toothpaste + mouthwash and SRP + toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 18 Dec 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients willing to participate to the study
- Rugby players
Who cannot join
- Patients with cardiac pacemaker
- Patients suffering from neurological disorders
- Patients suffering from psychological disorders
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: A New Domiciliary Oral Care Protocol for the Management of Dental Erosion in Rugby Players: A Randomized Clinical Trial
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).
Read the detailed 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).
- Conditions
- Dental Erosion
- Being tested
- SRP + toothpaste + mouthwash, SRP + toothpaste
- Keywords
- enamel remineralization
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRP + toothpaste + mouthwashOther
Use of domiciliary products twice a day
SRP + toothpasteOther
Use of domiciliary products twice a day
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | SRP + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day Receives: Other: SRP + toothpaste |
| Group 2 | Experimental | SRP + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day Receives: Other: SRP + toothpaste + mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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;
- 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.
Measured: 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;
- initial loss of surface texture;
- distinct defect, hard tissue loss < 50% of the surface area;
- hard tissue loss ≥ 50% of the surface area.
Measured: 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.
Measured: Study begin and after 15, 30 and 90 days.
Dental sensitivity
Assessment of dental sensitivity with a VAS scale (score: from 1 to 10)
Measured: Study begin and after 15, 30 and 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start18 Dec 2021
- Primary completion27 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ErosionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140538
- Sponsor's protocol ID
- 2021-RUGBY
- Status last verified
- May 2022
- First submitted
- 18 Nov 2021
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Domiciliary Oral Care Protocol for the Management of Dental Erosion in Rugby Players: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05140538
- Acronym / sponsor ID
- 2021-RUGBY
- Conditions
- Dental Erosion
- Keywords
- enamel remineralization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: SRP + toothpasteSRP + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day |
| Group 2 | Experimental | Other: SRP + toothpaste + mouthwashSRP + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients willing to participate to the study
- Rugby players
Key exclusion criteria (4 listed)
- Patients with cardiac pacemaker
- Patients suffering from neurological disorders
- Patients suffering from psychological disorders
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRP + toothpaste + mouthwashUse of domiciliary products twice a day | Other | Group 2 |
| SRP + toothpasteUse of domiciliary products twice a day | Other | Group 1 |
Primary outcome
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).
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; 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.
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; 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.
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRP + toothpaste + mouthwash and SRP + toothpaste in people with Dental Erosion, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BOP - Bleeding on Probing (percentage) (time frame: Study begin, 1 and 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.