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

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.

Study Overview

• Status: Completed
• Conditions: White Spot Lesion
• Intervention / Treatment: Procedure: Remin Pro® and MI Paste Plus®

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 Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • San Luis Potosi, Mexico, 78990
    • Faculty of Dentistry, Universidad Autónoma de san Luis Potosi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Remin Pro® and MI Paste Plus®; Te toothastes were applied at home twice a day over the six anterior upper primary teeth
Experimental: 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.	Procedure: Remin Pro® and MI Paste Plus®; Te toothastes were applied at home twice a day over the six anterior upper primary teeth
Active Comparator: 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.	Procedure: Remin Pro® and MI Paste Plus®; Te toothastes were applied at home twice a day over the six anterior upper primary teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	21 days

Collaborators and Investigators

• Sponsor: Universidad Autonoma de San Luis Potosí
• Investigators: Study Director: Amaury Pozos-Guillén, PhD, San Luis Potosi University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): September 9, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Primary teeth; Remineralisation; Enamel
• Other Study ID Numbers: JRangel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No