Comparison of Remineralisation Efficacy of MI PASTE Plus® and REMIN PRO® for White Spot Lesions in Primary Teeth
- Conditions
- White Spot Lesion
- Interventions
- Procedure: Remin Pro® and MI Paste Plus®
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
- 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
- History of hypersensitivity to any of the compounds of the pastes
- Enamel hypoplasia
- Compromising systemic diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COLGATE Total Remin Pro® and 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. MI PASTE PLUS Remin Pro® and 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. REMIN paste Remin Pro® and 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.
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Faculty of Dentistry, Universidad Autónoma de san Luis Potosi
🇲🇽San Luis Potosi, Mexico