| Literature DB >> 35978074 |
Katarzyna Grocholewicz1, Paulina Mikłasz1, Alicja Zawiślak1,2, Ewa Sobolewska3, Joanna Janiszewska-Olszowska4.
Abstract
This randomized, parallel, controlled trial assessed the effect of fluoride varnish, ozone and octenidine on white spot lesions (WSLs) and caries during orthodontic treatment. Patients were enrolled between 1st September 2017 and 31st August 2020 at initiation of orthodontic treatment in Department of Interdisciplinary Dentistry Pomeranian Medical University in Szczecin, Poland. All participants were randomly assigned to four study and one control groups using number random generator. However, investigators were not blinded due to the nature of the study. Groups I, II, III, IV had professional cleaning and varnishing (5% NaF) every 4 weeks. Groups II and IV had in-office ozone therapy before varnishing, groups III and IV received domestic octenidine mouthrinse. Group K had no professional hygienic or prophylactic procedures. WSLs were assessed at T0 and then every 4 weeks (T1-T4) and caries-at T0 and T4. The specific objective was to assess the influence of fluoride varnish, ozone and octenidine on the incidence of white spot lesions and caries during orthodontic treatment. The primary outcome of this report was the highest number of WSLs in group K and the lowest percentage of patients with WSLs in group IV. Each group comprised 30 randomized participants; they were all analyzed. No WSLs were found at T0, but they were stated in all groups at T4. The numbers of patients with WSLs significantly increased between T0-T4 in groups I and K. Group IV had the lowest percentage of patients with WSLs in T1-T4. WSLs in group IV were found no earlier than at T2. Group K had the highest percentage of WSLs at T4: 26%. At T0 all the groups had DMFs above 0 with a significant increase at T4. No side effects of the introduced prophylaxis were observed in any group. Caries is an important problem of fixed orthodontic treatment. Even an extremely intensive prophylaxis could not completely prevent WSLs and caries. Simultaneous application of fluoride varnish, ozone gas exposure and octenidine appears to have a beneficial effect in limiting the development of WSLs.Trial registration: NCT04992481.Entities:
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Year: 2022 PMID: 35978074 PMCID: PMC9385708 DOI: 10.1038/s41598-022-18107-w
Source DB: PubMed Journal: Sci Rep ISSN: 2045-2322 Impact factor: 4.996
Distribution of the study and control groups according to sex.
| Group | Men | Women | ||
|---|---|---|---|---|
| n | % | n | % | |
| I | 10 | 33.33 | 20 | 66.67 |
| II | 7 | 23.33 | 23 | 76.67 |
| III | 8 | 26.67 | 22 | 73.33 |
| IV | 7 | 23.33 | 23 | 76.67 |
| K | 7 | 23.33 | 23 | 76.67 |
| Total | 39 | 26 | 111 | 74 |
Input and output for sample size planning for repeated-measures ANOVA. ()
| f | ng | nm | nscor | Alpha | Power | n |
|---|---|---|---|---|---|---|
| 0.25 | 5 | 2 | 0.7 | 0.05 | 0.75 | 144.4 |
n sample size, ng number of groups, nm number of measurements, f effect size (prior medium value = 0.25), nscor sphericity correction coefficient (0.7 for non-sphericity data), alpha significance level, type type of effect analysis (1 for within type), power statistical power.
Figure 1Consort flow diagram.
Number of patients with WSLs in the study and control groups in subsequent examinations.
| Group | Examination | n (%) | T0 versus T4 |
|---|---|---|---|
| P | |||
| I | T0 | 0 (0.00) | 0.01777 |
| T1 | 2 (6.67) | ||
| T2 | 5 (16.67) | ||
| T3 | 5 (16.67) | ||
| T4 | 5 (16.67) | ||
| II | T0 | 0 (0.00) | 0.05590 (NS) |
| T1 | 1 (3.33) | ||
| T2 | 3 (10.00) | ||
| T3 | 3 (10.00) | ||
| T4 | 3 (10.00) | ||
| III | T0 | 0 (0.00) | 0.06478 (NS) |
| T1 | 1 (3.33) | ||
| T2 | 3 (10.00) | ||
| T3 | 3 (10.00) | ||
| T4 | 3 (10.00) | ||
| IV | T0 | 0 (0.00) | 0.05414 (NS) |
| T1 | 0 (0.00) | ||
| T2 | 1 (3.33) | ||
| T3 | 2 (6.67) | ||
| T4 | 2 (6.67) | ||
| K | T0 | 0 (0.00) | 0.00040 |
| T1 | 2 (6.67) | ||
| T2 | 4 (13.33) | ||
| T3 | 7 (23.33) | ||
| T4 | 8 (26.67) |
Figure 2Distribution of the severity and number of WSLs in the study and control groups at the final examination (T4).
Basic descriptive statistics of T0, T4 DMFs values (Time) by a grouping variable (Group).
| Group | Examination | Mean | SD | Median | Min | Max | Q1 | Q3 |
|---|---|---|---|---|---|---|---|---|
| I | T0 | 0.15 | 0.13 | 0.10 | 0 | 0.40 | 0.04 | 0.23 |
| II | 0.12 | 0.08 | 0.10 | 0 | 0.40 | 0.07 | 0.18 | |
| III | 0.11 | 0.08 | 0.10 | 0 | 0.32 | 0.05 | 0.12 | |
| IV | 0.09 | 0.07 | 0.06 | 0.02 | 0.26 | 0.04 | 0.13 | |
| K | 0.15 | 0.12 | 0.13 | 0 | 0.40 | 0.06 | 0.20 | |
| I | T4 | 0.17 | 0.14 | 0.12 | 0.01 | 0.43 | 0.04 | 0.23 |
| II | 0.16 | 0.11 | 0.12 | 0.02 | 0.5 | 0.09 | 0.21 | |
| III | 0.13 | 0.09 | 0.11 | 0 | 0.34 | 0.06 | 0.20 | |
| IV | 0.10 | 0.07 | 0.7 | 0.03 | 0.26 | 0.04 | 0.14 | |
| K | 0.19 | 0.12 | 0.17 | 0.02 | 0.50 | 0.08 | 0.24 |
Statistical significance for T0, T4 pairwise comparisons within each group by using sign test (pairwise_sign_test(), {rstatix} package).
| Groups | n1 | n2 | df | p | p.adj |
|---|---|---|---|---|---|
| I | 30 | 30 | 16 | < 0.001 | < 0.001 |
| II | 16 | < 0.001 | < 0.001 | ||
| III | 15 | < 0.001 | < 0.001 | ||
| IV | 8 | 0.008 | 0.008 | ||
| K | 27 | < 0.001 | < 0.001 |
n1, n2 sample counts for T0, T4 respectively, df the total number of differences (degrees of freedom), p p-value, p.adj -value adjusted by “holm” method.