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Completed

NCT Number: NCT04382287

Comparison of Remineralisation Efficacy of MI PASTE Plus® and REMIN PRO® for 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.

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Key information

Conditions

White Spot Lesion

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Universidad Autónoma de san Luis Potosi

San Luis Potosí City, 78990, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remin Pro® and MI Paste Plus®

Procedure

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

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de San Luis Potosí

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 11, 2020
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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