Comparison of Remineralisation Efficacy of MI PASTE Plus® and REMIN PRO® for White Spot Lesions in Primary Teeth
NCT ID: NCT04382287
Last Updated: 2020-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
123 participants
INTERVENTIONAL
2019-04-01
2019-11-20
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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REMIN paste
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.
Remin Pro® and MI Paste Plus®
Te toothastes were applied at home twice a day over the six anterior upper primary teeth
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.
Remin Pro® and MI Paste Plus®
Te toothastes were applied at home twice a day over the six anterior upper primary teeth
COLGATE Total
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.
Remin Pro® and MI Paste Plus®
Te toothastes were applied at home twice a day over the six anterior upper primary teeth
Interventions
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Remin Pro® and MI Paste Plus®
Te toothastes were applied at home twice a day over the six anterior upper primary teeth
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Enamel hypoplasia
* Compromising systemic diseases
2 Years
5 Years
ALL
Yes
Sponsors
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Universidad Autonoma de San Luis Potosí
OTHER
Responsible Party
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José Arturo Garrocho Rangel
Ph.D.
Principal Investigators
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Amaury Pozos-Guillén, PhD
Role: STUDY_DIRECTOR
San Luis Potosi University
Locations
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Faculty of Dentistry, Universidad Autónoma de san Luis Potosi
San Luis Potosí City, , Mexico
Countries
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Other Identifiers
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JRangel
Identifier Type: -
Identifier Source: org_study_id
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