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Comparison of Remineralisation Efficacy of MI PASTE Plus® and REMIN PRO® for White Spot Lesions in Primary Teeth

Comparison of Clinical Efficacy of MI PASTE Plus® and REMIN PRO® for the Remineralisation of Enamel White Spot Lesions in Primary Teeth

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04382287
Enrollment
123
Registered
2020-05-11
Start date
2019-04-01
Completion date
2019-11-20
Last updated
2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesion

Keywords

Primary teeth, Enamel, Remineralisation

Brief 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.

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.

Interventions

PROCEDURERemin Pro® and MI Paste Plus®

Te toothastes were applied at home twice a day over the six anterior upper primary teeth

Sponsors

Universidad Autonoma de San Luis Potosí
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

The three provided pastes had a similar physical appearance

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* History of hypersensitivity to any of the compounds of the pastes * Enamel hypoplasia * Compromising systemic diseases

Design outcomes

Primary

MeasureTime frameDescription
Enamel remineralisation degree10 daysThe 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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026