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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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White Spot Lesion

Intervention / Treatment
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* Procedure: Remin Pro® and MI Paste Plus®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REMIN paste<br>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®<br>* Te toothastes were applied at home twice a day over the six anterior upper primary teeth<br>|
| Experimental: MI PASTE PLUS<br>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®<br>* Te toothastes were applied at home twice a day over the six anterior upper primary teeth<br>|
| Active Comparator: COLGATE Total<br>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®<br>* Te toothastes were applied at home twice a day over the six anterior upper primary teeth<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary teeth, Enamel, Remineralisation