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

Not Applicable

Completed

• Conditions: White Spot Lesion

• Registration Number: NCT04382287
• Lead Sponsor: Universidad Autonoma de San Luis Potosí

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.

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-09-09
• Study Completion: 2019-11-20
• Status Verified: 2020-05
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-07
• Last Update Submitted: 2020-05-07
• Study First Posted: 2020-05-11
• Last Update Posted: 2020-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Enamel remineralisation degree	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

Trial Locations

Locations (1)

Faculty of Dentistry, Universidad Autónoma de san Luis Potosi; 🇲🇽 San Luis Potosi, Mexico