White Spot LesionNCT04382287
Comparison of Remineralisation Efficacy of MI PASTE Plus® and REMIN PRO® for White Spot Lesions in Primary Teeth
A study testing Remin Pro® and MI Paste Plus® in people with White Spot Lesion, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
The present study aimed to compare the remineralisation capacity of white spot enamel lesions between two commercially available tooth pastes (Remin Pro and MI PASTE PLUS), applied at home twice a day on the anterior upper primary teeth by the patient and parents. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Remin Pro® and MI Paste Plus®
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2019to 20 Nov 2019
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Young paediatric patients with at least one upper anterior primary tooth exhibiting one or several WSL on the smooth enamel surface.
- Attending the Paediatric Dentistry Postgraduate Program's Clinic
- Enamel lesions with units of fluorescence (UF) ranging from 11-20 as determined by DIAGNOdent
- Signed Informed Consent
Who cannot join
- History of hypersensitivity to any of the compounds of the pastes
- Enamel hypoplasia
- Compromising systemic diseases
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Faculty of Dentistry, Universidad Autónoma de san Luis Potosi
San Luis Potosí City, 78990
About this study
Official title: Comparison of Clinical Efficacy of MI PASTE Plus® and REMIN PRO® for the Remineralisation of Enamel White Spot Lesions in Primary Teeth
The present study aimed to compare the remineralisation capacity of white spot enamel lesions between two commercially available tooth pastes (Remin Pro and MI PASTE PLUS), applied at home twice a day on the anterior upper primary teeth by the patient and parents.
Read the detailed description
Objective: To evaluate and compare the clinical efficacy of Remin Pro® and MI Paste Plus® for the remineralisation of white spot lesions (WSL) on the enamel of primary teeth.
Methods: The selected design for this study was a randomised double-blind clinical trial based on CONSORT guidelines. Patients with at least one upper anterior primary tooth with a WSL on the enamel surface, with units of fluorescence (UF) ranged from 11-20 (evaluated with DIAGNOdent) were included in the study. Patients were randomly assigned to receive either the twice-daily at-home topical application of Remin Pro® or MI Paste Plus® (both as experimental pastes) or Colgate Total® (as control paste). The degree of remineralisation was quantified by the change in the number of UF from the baseline evaluation and at days 10 and 21. The difference between groups was statistically evaluated using ANCOVA and ANOVA techniques.
- Conditions
- White Spot Lesion
- Being tested
- Remin Pro® and MI Paste Plus®
- Keywords
- Primary teeth, Enamel, Remineralisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remin Pro® and MI Paste Plus®Procedure or surgery
Te toothastes were applied at home twice a day over the six anterior upper primary teeth
| Study group | Role | What they receive |
|---|---|---|
| REMIN paste | Experimental | The child's parents or caregivers were provided with printed instructions for applying the paste at home. The indicated procedure was as follows: application of the remineralisation agent was limited to the tooth's vestibular surface twice a day, after conventional toothbrushing (both in the morning and at night). The maximal amount of paste to be applied was equal to a pea-sized portion (one finger) per surface. The paste was applied using the parent or caregiver's finger across the WSL surface. After the application of the paste, patients were asked to avoid eating or drinking anything for the next hour. Receives: Procedure: Remin Pro® and MI Paste Plus® |
| MI PASTE PLUS | Experimental | The child's parents or caregivers were provided with printed instructions for applying the paste at home. The indicated procedure was as follows: application of the remineralisation agent was limited to the tooth's vestibular surface twice a day, after conventional toothbrushing (both in the morning and at night). The maximal amount of paste to be applied was equal to a pea-sized portion (one finger) per surface. The paste was applied using the parent or caregiver's finger across the WSL surface. After the application of the paste, patients were asked to avoid eating or drinking anything for the next hour. Receives: Procedure: Remin Pro® and MI Paste Plus® |
| COLGATE Total | Active comparator | The child's parents or caregivers were provided with printed instructions for applying the paste at home. The indicated procedure was as follows: application of the remineralisation agent was limited to the tooth's vestibular surface twice a day, after conventional toothbrushing (both in the morning and at night). The maximal amount of paste to be applied was equal to a pea-sized portion (one finger) per surface. The paste was applied using the parent or caregiver's finger across the WSL surface. After the application of the paste, patients were asked to avoid eating or drinking anything for the next hour. Receives: Procedure: Remin Pro® and MI Paste Plus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enamel remineralisation degree
The remineralisation degree was quantified by the change in UF from the baseline (0 day) up to day 10 of twice-daily applications, by evaluation on the 10th day.
Measured: 10 days
Enamel remineralisation degree
The remineralisation degree was quantified by the change in UF from the 10th day up to the 21st day, after twice-daily applications
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Apr 2019
- Primary completion9 Sep 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- A randomised double-blind clinical trial, with three parallel study groups (two experimental and one control), whose participants were randomly assigned to one of te three groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Arturo Garrocho Rangel, Universidad Autonoma de San Luis Potosí
- Investigators
- Amaury Pozos-Guillén, PhD, Study director, San Luis Potosi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382287
- Sponsor's protocol ID
- JRangel
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Efficacy of MI PASTE Plus® and REMIN PRO® for the Remineralisation of Enamel White Spot Lesions in Primary Teeth
- ClinicalTrials.gov ID
- NCT04382287
- Acronym / sponsor ID
- JRangel
- Conditions
- White Spot Lesion
- Keywords
- Primary teeth, Enamel, Remineralisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 11 May 2020 (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 present study aimed to compare the remineralisation capacity of white spot enamel lesions between two commercially available tooth pastes (Remin Pro and MI PASTE PLUS), applied at home twice a day on the anterior upper primary teeth by the patient and parents.
Detailed description
Objective: To evaluate and compare the clinical efficacy of Remin Pro® and MI Paste Plus® for the remineralisation of white spot lesions (WSL) on the enamel of primary teeth.
Methods: The selected design for this study was a randomised double-blind clinical trial based on CONSORT guidelines. Patients with at least one upper anterior primary tooth with a WSL on the enamel surface, with units of fluorescence (UF) ranged from 11-20 (evaluated with DIAGNOdent) were included in the study. Patients were randomly assigned to receive either the twice-daily at-home topical application of Remin Pro® or MI Paste Plus® (both as experimental pastes) or Colgate Total® (as control paste). The degree of remineralisation was quantified by the change in the number of UF from the baseline evaluation and at days 10 and 21. The difference between groups was statistically evaluated using ANCOVA and ANOVA techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- A randomised double-blind clinical trial, with three parallel study groups (two experimental and one control), whose participants were randomly assigned to one of te three groups.
| Arm | Type | Receives |
|---|---|---|
| REMIN paste | Experimental | Procedure: Remin Pro® and MI Paste Plus®The child's parents or caregivers were provided with printed instructions for applying the paste at home. The indicated procedure was as follows: application of the remineralisation agent was limited to the tooth's vestibular surface twice a day, after conventional toothbrushing (both in the morning and at night). The maximal amount of paste to be applied was equal to a pea-sized portion (one finger) per surface. The paste was applied using the parent or caregiver's finger across the WSL surface. After the application of the paste, patients were asked to avoid eating or drinking anything for the next hour. |
| MI PASTE PLUS | Experimental | Procedure: Remin Pro® and MI Paste Plus®The child's parents or caregivers were provided with printed instructions for applying the paste at home. The indicated procedure was as follows: application of the remineralisation agent was limited to the tooth's vestibular surface twice a day, after conventional toothbrushing (both in the morning and at night). The maximal amount of paste to be applied was equal to a pea-sized portion (one finger) per surface. The paste was applied using the parent or caregiver's finger across the WSL surface. After the application of the paste, patients were asked to avoid eating or drinking anything for the next hour. |
| COLGATE Total | Active comparator | Procedure: Remin Pro® and MI Paste Plus®The child's parents or caregivers were provided with printed instructions for applying the paste at home. The indicated procedure was as follows: application of the remineralisation agent was limited to the tooth's vestibular surface twice a day, after conventional toothbrushing (both in the morning and at night). The maximal amount of paste to be applied was equal to a pea-sized portion (one finger) per surface. The paste was applied using the parent or caregiver's finger across the WSL surface. After the application of the paste, patients were asked to avoid eating or drinking anything for the next hour. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Young paediatric patients with at least one upper anterior primary tooth exhibiting one or several WSL on the smooth enamel surface.
- Attending the Paediatric Dentistry Postgraduate Program's Clinic
- Enamel lesions with units of fluorescence (UF) ranging from 11-20 as determined by DIAGNOdent
- Signed Informed Consent
Key exclusion criteria (3 listed)
- History of hypersensitivity to any of the compounds of the pastes
- Enamel hypoplasia
- Compromising systemic diseases
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 |
|---|---|---|
| Remin Pro® and MI Paste Plus®Te toothastes were applied at home twice a day over the six anterior upper primary teeth | Procedure or surgery | COLGATE Total, MI PASTE PLUS, REMIN paste |
Primary outcome
Enamel remineralisation degree
Time frame: 10 days
The remineralisation degree was quantified by the change in UF from the baseline (0 day) up to day 10 of twice-daily applications, by evaluation on the 10th day.
Enamel remineralisation degree
Time frame: 21 days
The remineralisation degree was quantified by the change in UF from the 10th day up to the 21st day, after twice-daily applications
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 11 May 2020.
- Individual participant dataSharing planned: No
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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.
Amaury Pozos-Guillén, PhD study director
San Luis Potosi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remin Pro® and MI Paste Plus® in people with White Spot Lesion, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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 3 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 11 May 2020. 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 Mexico. 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?
Enamel remineralisation degree (time frame: 10 days). The study lists 2 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 11 May 2020.