White Spot LesionNCT04908293
Home Remineralization of White Spot Lesions With Two Different Toothpastes.
A study testing Biorepair toothpaste and Colgate toothpaste in people with White Spot Lesion, run by University of Pavia at 1 site in Italy.
Trial summary
The aim of the study is to compare white spot lesions before, during and after treatment with New Biorepair Advanced Sensitive toothpaste containing micro crystals of hydroxyapatite and Colgate toothpaste with 1450 ppm of fluoride. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Biorepair toothpaste and Colgate 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
- 28 May 2021to 20 Oct 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with white spot lesions;
- patients with dental sensibility;
- adult patients;
- patients that sign the informed consent to participate to the study.
Who cannot join
- patients with low compliance or motivation to participate to the study;
- patients not presenting white spot lesions;
- patients with absence of dental sensibility;
- patients pregnant or breastfeeding;
- underage patients;
- patients with psychiatric diseases.
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 Comparison Between a Toothpaste With Micro Crystals of Hydroxyapatite and a Toothpaste With 1450 Ppm of Fluoride in the Home Remineralization of White Spot Lesions: a Clinical Trial.
The aim of the study is to compare white spot lesions before, during and after treatment with New Biorepair Advanced Sensitive toothpaste containing micro crystals of hydroxyapatite and Colgate toothpaste with 1450 ppm of fluoride. The timeline will consider the study begin, 15 days, 30 days and 90 days after the beginning of the study. The following indices will be recorded: BEWE Index, Schiff Air Index, VAS scale. After that, patients will fill in a satisfaction questionnaire.
Read the detailed description
The aim of the study is to compare white spot lesions before, during and after treatment with two different toothpastes for home oral care. Patients who agree to sign the informed consent will be randomly assigned to two different groups:
- Trial Group will use New Biorepair Advanced Sensitive toothpaste containing micro crystals of hydroxyapatite;
- Control Group will use Colgate toothpaste with 1450 ppm of fluoride.
At the baseline, professional oral hygiene will be performed. The following indices will be recorded at the study begin and at the following 15, 30 and 90 days: BEWE Index, Schiff Air Index, VAS scale. After that, patients will fill in a satisfaction questionnaire.
- Conditions
- White Spot Lesion
- Being tested
- Biorepair toothpaste, Colgate toothpaste
- Keywords
- remineralization, hydroxyapatite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biorepair toothpasteOther
Use of New Biorepair Advanced Sensitive for home oral care.
Colgate toothpasteOther
Use of Colgate toothpaste for home oral care.
| Study group | Role | What they receive |
|---|---|---|
| Trial Group | Experimental | Use of New Biorepair Advanced Sensitive toothpaste for home oral care. Receives: Other: Biorepair toothpaste |
| Control Group | Active comparator | Use of Colgate toothpaste for home oral care. Receives: Other: Colgate toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, 15, 30 and 90 days.
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, 15, 30 and 90 days.
Change in VAS score
Evaluation of the evoked pain with air blasting from 0 to 10. The VAS scale is a straight line with the endpoints defining extreme limits with "no pain at all"and "pain as bad as it could be"; they correspond respectively to 0 and 10. The patient indicates the score of the perceived pain from 0 to 10.
Measured: Study begin, 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 Jun 2021
- Study start28 May 2021
- Primary completion15 Oct 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, 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
- NCT04908293
- Sponsor's protocol ID
- 2021-WHITESPOTS
- Status last verified
- Oct 2021
- First submitted
- 23 May 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to Principal Investigator.
Publications
Butera A, Gallo S, Pascadopoli M, Montasser MA, Abd El Latief MH, Modica GG, Scribante A. Home Oral Care with Biomimetic Hydroxyapatite vs. Conventional Fluoridated Toothpaste for the Remineralization and Desensitizing of White Spot Lesions: Randomized Clinical Trial. Int J Environ Res Public Health. 2022 Jul 16;19(14):8676. doi: 10.3390/ijerph19148676.
PubMed 35886524
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between a Toothpaste With Micro Crystals of Hydroxyapatite and a Toothpaste With 1450 Ppm of Fluoride in the Home Remineralization of White Spot Lesions: a Clinical Trial.
- ClinicalTrials.gov ID
- NCT04908293
- Acronym / sponsor ID
- 2021-WHITESPOTS
- Conditions
- White Spot Lesion
- Keywords
- remineralization, hydroxyapatite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 1 Jun 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 study is to compare white spot lesions before, during and after treatment with New Biorepair Advanced Sensitive toothpaste containing micro crystals of hydroxyapatite and Colgate toothpaste with 1450 ppm of fluoride. The timeline will consider the study begin, 15 days, 30 days and 90 days after the beginning of the study. The following indices will be recorded: BEWE Index, Schiff Air Index, VAS scale. After that, patients will fill in a satisfaction questionnaire.
Detailed description
The aim of the study is to compare white spot lesions before, during and after treatment with two different toothpastes for home oral care. Patients who agree to sign the informed consent will be randomly assigned to two different groups:
- Trial Group will use New Biorepair Advanced Sensitive toothpaste containing micro crystals of hydroxyapatite;
- Control Group will use Colgate toothpaste with 1450 ppm of fluoride.
At the baseline, professional oral hygiene will be performed. The following indices will be recorded at the study begin and at the following 15, 30 and 90 days: BEWE Index, Schiff Air Index, VAS scale. After that, patients will fill in a satisfaction questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Group | Experimental | Other: Biorepair toothpasteUse of New Biorepair Advanced Sensitive toothpaste for home oral care. |
| Control Group | Active comparator | Other: Colgate toothpasteUse of Colgate toothpaste for home oral care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with white spot lesions;
- patients with dental sensibility;
- adult patients;
- patients that sign the informed consent to participate to the study.
Key exclusion criteria (6 listed)
- patients with low compliance or motivation to participate to the study;
- patients not presenting white spot lesions;
- patients with absence of dental sensibility;
- patients pregnant or breastfeeding;
- underage patients;
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 |
|---|---|---|
| Biorepair toothpasteUse of New Biorepair Advanced Sensitive for home oral care. | Other | Trial Group |
| Colgate toothpasteUse of Colgate toothpaste for home oral care. | Other | Control Group |
Primary outcome
Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)
Time frame: Study begin, 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 Schiff Air Index - Dental sensitivity test
Time frame: Study begin, 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 in VAS score
Time frame: Study begin, 15, 30 and 90 days.
Evaluation of the evoked pain with air blasting from 0 to 10. The VAS scale is a straight line with the endpoints defining extreme limits with "no pain at all"and "pain as bad as it could be"; they correspond respectively to 0 and 10. The patient indicates the score of the perceived pain from 0 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 28 Oct 2021.
- Derived from this study: PubMed 35886524Butera A, Gallo S, Pascadopoli M, Montasser MA, Abd El Latief MH, Modica GG, Scribante A. Home Oral Care with Biomimetic Hydroxyapatite vs. Conventional Fluoridated Toothpaste for the Remineralization and Desensitizing of White Spot Lesions: Randomized Clinical Trial. Int J Environ Res Public Health. 2022 Jul 16;19(14):8676. doi: 10.3390/ijerph19148676.
- 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 Biorepair toothpaste and Colgate toothpaste in people with White Spot Lesion, 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 4 inclusion and 6 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 28 Oct 2021. 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 of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008) (time frame: Study begin, 15, 30 and 90 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04908293, which also lists 1 linked publication.
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 28 Oct 2021.