Effectiveness of MI Paste Plus and Remin Pro on Remineralization of Post-Orthodontic White Spot Lesions
Condition: White Spot Lesion; Remineralization
MeSH terms: Exanthema
Study type: Interventional

Summary: 
      One of the most undesired side effects of fixed orthodontic treatment is white spot lesions
      (WSLs), that appear on the buccal surface of teeth and cause aesthetic problems. The aim of
      this prospective study was to quantitively evaluate the remineralization effect of casein
      phosphopeptide-amorphous calcium fluorophosphate (CPP-ACFP) containing (MI Paste Plus®) and
      hydroxyapatite, xylitol and fluoride containing (Remin Pro®) agents in remineralizing post
      orthodontics white spots using Quantitive Light-Induced Fluorescence Method (QLF) and ICDAS
      II criteria, compared to a control group in whom just a routine home care was instructed.
      Thirty-nine individuals who had recently completed orthodontic treatment, had at least one
      WSL on upper anterior teeth and aged between 12-25 years were included. The participants were
      randomly assigned into three groups of 13 each; (1) MI Paste Plus + routine home care; (2)
      Remin Pro + routine home care; and (3) routine home care (control). The treatment/
      observation period was 12 weeks after bracket debonding. Fluorescence loss (∆F, %), lesion
      area (LA, mm2), lesion volume (∆Q, % × mm2), maximum fluorescence loss (∆Fmax), ICDAS II
      criteria of WSLs were measured at beginning (T0) and 4 (T1), 8 (T2), and 12 (T3) weeks later.
      Statistical significance was set at p<0.05.
    

Detailed description: 
      This randomized controlled trial was a parallel arm 1-1 allocations. The study carried out in
      the Orthodontics Department, Izmir Katip Celebi University, Turkey. The protocol of the trial
      was approved by the Izmir Katip Celebi University Research Ethics Committee. A power analysis
      was carried out to provide that there was enough power to apply a statistical test of the
      research hypothesis to compare caries regression of Remin Pro to MI Paste Plus comparing with
      a control group in the remineralization of postorthodontic WSLs. Patients who finished their
      fixed appliance treatment in the clinic of the Department of Orthodontics, Faculty of
      Dentistry, Izmir Katip Celebi University who were found to comply with the study criteria
      were informed. Patients and parents who agreed to participate in the study signed an informed
      consent. A total of 39 people, 22 women and 17 men, aged between 14 and 23, were included in
      the study, with 13 people in each group. Gender distribution and average age of the groups
      are similar. Patients who are 12 to 25 years of age, at least had 12 months of orthodontic
      treatment with braces, at least had one upper anterior tooth with WSL included in the study.
      Patient who are smoking, with enamel hypoplasia or fluorosis, with active periodontal
      disease, with dentin caries, with allergy to casein, with previous bleaching excluded. Simple
      randomization was performed at the start of the study using a random number table prepared
      using SPSS software (version 26.0; New York, USA) for the allocation of patients who
      fulfilled all criteria and were willing to participate in this study. Group I: Patients were
      instructed to use MI Paste Plus (GC Europe, Leuven, Belgium) according to manufacturers
      instructions. Group II: Patients were instructed to use (Remin Pro, VOCO , Cuxhaven, Germany)
      a pea-sized amount of the cream. Group III. Patients (control group) used a 1450 ppm
      fluoridated tooth paste (Colgate Sensitive Pro-Relief, Colgate-Palmolive, Swidnica, Poland)
      for conventional tooth brushing and instructed to follow a routine home care. The patients
      were evaluated at baseline (T0) and every 30 days intervals for 3 months. The primary outcome
      measures were assessment of mineral loss based on fluorescence loss measurements using QLF.
      Lesions that scored 1 and 2 according to ICDAS II at debonding were included in the study.
      The buccal surfaces of the teeth were examined and evaluated by light induced fluorescence
      intraoral camera QLF-D Biluminator,™ (Inspektor-Pro, Amsterdam, Holland) for capturing
      fluorescent photographs in accordance with the manufacturer's instructions. Fluorescent
      images of the patient were evaluated in the 'White Spot Lesion' option of the analysis
      program (QA2.v.1.27). Following five QLF measurements were performed;

        1. Depth of lesion (∆F, %) shows the percentage of loss in fluorescence.

        2. Lesion area (LA, mm2) refers to the area covered by the demineralized area on the tooth.

        3. Lesion volume (∆Q, % × mm2) is derived from the combination of lesion area and lesion
           depth and represents the volume of the affected enamel.

        4. Maximum fluorescence loss (∆Fmax)is related to depth of lesion and mineral loss.
           Statistical analysis was performed with IBM® SPSS® (version 26. SPSS Inc., IBM
           Corporation, NewYork, USA). Descriptive statistics are expressed as number of units (n),
           percent (%), mean ± standard deviation (x ̅±ss), median (M), minimum (min), maximum
           (max), and interquartile range (IQR) values. The normal distribution of the data was
           evaluated with the Shapiro Wilk test of normality. Homogenicity of variances was
           evaluated with Levene's test.The concordance and differences in the first measurements
           and the second measurements were evaluated with the intra-class correlation coefficient
           and the paired samples t test. The ages of the groups were compared with one-way
           analysis of variance. The ΔF, lesion area and ΔFmax values of the groups in T0, T1, T2
           and T3 were compared with two-way analysis of variance in repeated measurements.
           Bonferroni correction was applied in multiple comparisons. ΔQ, ICDAS II score, and
           difference values from baseline were compared between groups by Kruskal-Wallis analysis.
           In case of difference with Kruskal-Wallis analysis, Dunn-Bonferroni test was used for
           multiple comparisons. For ΔQ, ICDAS II score, Friedman analysis was performed for
           intragroup timepoint comparisons. Bonferroni correction was applied in multiple
           comparisons for Friedman analysis. Fisher Exact test was used to compare groups with
           categorical variables. If the chi-square test result was found to be significant,
           subgroup analyzes were performed with Bonferroni-corrected two-ratio z-test. Statistical
           significance level was set at p<0.05.
    

Intervention name(s): MI Paste Plus; Remin Pro; Control
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): Briefly, a pea-sized amount of the cream was used once a day and was allowed to remain on the teeth for three minutes after conventional tooth brushing. Patient was advised to not to spit out the cream for 30 seconds to activate the product with saliva. Patient was advised to spit out the remaining amount to avoid swallowing excessive fluoride and to wait for 30 minutes after the treatment before rinsing or eating or drinking.; The cream must remain on the teeth for at least three minutes once daily after conventional tooth brushing. Patient was advised to spit out the remaining amount to avoid swallowing excessive fluoride and to wait for 30 minutes after the treatment before rinsing or eating or drinking.; Patients instructed to follow a routine home care.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Thirty-nine patients were randomized in a 1:1:1 ratio to either MI Paste Plus or Remin Pro or control group.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: White Spot Lesion; Remineralization; QLF; ICDAS II