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

White Spot Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382287
• Other study ID #: JRangel
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: November 20, 2019

Study information

• Verified date: May 2020
• Source: Universidad Autonoma de San Luis Potosí
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: November 20, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesion

Intervention

Procedure:
• Remin Pro® and MI Paste Plus®
Te toothastes were applied at home twice a day over the six anterior upper primary teeth

Locations

Country	Name	City	State
Mexico	Faculty of Dentistry, Universidad Autónoma de san Luis Potosi	San Luis Potosi

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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