Effect of a Short-Term Intervention with Lactobacillus salivarius Probiotic on Early Childhood Caries—An Open Label Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Protocol
2.2. Participants
2.2.1. Selection Criteria
2.2.2. Settings and Locations Where the Data Were Collected
2.3. Interventions
2.4. Outcome Measures
2.5. Clinical Examination and Data Collection
2.6. Sample Size
2.7. Randomization, Allocation Concealment Mechanism, Implementation and Blinding
2.8. Statistical Methods
3. Results
3.1. Participants Flow
3.2. Recruitment
3.3. Baseline Data
3.4. Numbers Analyzed
3.5. Effect on Dental Caries
3.6. Effect on Dental Plaque
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Characteristic | Control Group | Probiotic Group | Dropouts | Control vs. Probiotic | Probiotic vs. Dropouts | Examine Groups vs. Dropouts |
---|---|---|---|---|---|---|
Participants, n | 70 | 57 | 13 | |||
Male, n (%) | 39 (55.71%) | 31 (54.39%) | 8 (61.54%) | p = 0.88 b | p = 0.64 b | p = 0.66 b |
Female, n (%) | 31 (44.29%) | 26 (45.61%) | 5 (38,.46%) | p = 0.88 b | p = 0.64 b | p = 0.66 b |
Age, mean ± SD | 4.51 ± 0.94 | 4.59 ± 0.92 | 4.46 ± 1.45 | p = 0.76 a | p = 0.9 a | p = 0.98 a |
ICDAS 1–6 > 0, n (%) | 35 (50%) | 28 (49.12%) | 6 (46.15%) | p = 0.93 b | p = 0.85 b | p = 0.81 b |
d(ICDAS 1–6) mft, mean ± SD | 5.67 ± 6.68 | 5.93 ± 6.68 | 5.23 ± 6.29 | p = 0.83 a | p = 0.66 a | p = 0.70 a |
OHI-S, mean ± SD | 0.88 ± 0.32 | 0.79 ± 0.43 | 0.86 ± 0.48 | p = 0.04a | p = 0.72 a | p = 0.93 a |
Effect | Cohen’s d | Mann-Whitney Test | Q3 | Q1 | Max | Min | SD | Median | Mean | n | Group | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
no effect | 0.016 | p = 0.925 | 9.75 | 0 | 20 | 0 | 6.68 | 3 | 5.671 | 70 | control | d(ICDAS 1–6) mft, baseline | |
12 | 0 | 20 | 0 | 6.68 | 3 | 5.93 | 57 | probiotic | |||||
small | 0.217 | p = 0.214 | 11.75 | 0 | 21 | 0 | 6.75 | 6 | 7.043 | 70 | control | d(ICDAS 1–6) mft, | 12 months |
11 | 0 | 20 | 0 | 6.26 | 4 | 5.825 | 57 | probiotic | |||||
large | 1.087 | p < 0.001 | 2 | 0 | 7 | 0 | 1.63 | 1 | 1.371 | 70 | control | Δ d(ICDAS 1–6) mft, | 12 months—baseline |
0 | 0 | 4 | −6 | 1.18 | 0 | −0.105 | 57 | probiotic | |||||
no effect | 0.074 | p = 0.661 | 6 | 0 | 14 | 0 | 4.38 | 1 | 3.429 | 70 | control | d(ICDAS 1–2) mft, baseline | |
7 | 0 | 15 | 0 | 4.75 | 2 | 3.947 | 57 | probiotic | |||||
small | 0.135 | p = 0.434 | 7 | 0 | 18 | 0 | 5.04 | 4 | 4.643 | 70 | control | d(ICDAS 1–2) mft, | 12 months |
8 | 0 | 15 | 0 | 4.72 | 3 | 4.07 | 57 | probiotic | |||||
intermediate | 0.517 | p = 0.002 | 3 | 0 | 11 | −5 | 2.5 | 0 | 1.214 | 70 | control | Δ d(ICDAS 1–2) mft, | 12 months—baseline |
0 | 0 | 5 | −4 | 1.45 | 0 | 0.123 | 57 | probiotic | |||||
no effect | 0.029 | p = 0.865 | 7 | 0 | 14 | 0 | 4.61 | 3 | 3.971 | 70 | control | d(ICDAS 3–6) mft, baseline | |
7 | 0 | 15 | 0 | 4.86 | 2 | 4.053 | 57 | probiotic | |||||
small | 0.215 | p = 0.218 | 10 | 0 | 21 | 0 | 6.35 | 6 | 6.5 | 70 | control | d(ICDAS 3–6) mft, | 12 months |
10 | 0 | 19 | 0 | 5.89 | 2 | 5.228 | 57 | probiotic | |||||
intermediate | 0.593 | p < 0.001 | 4.75 | 0 | 10 | −5 | 2.84 | 2 | 2.529 | 70 | control | Δ d(ICDAS 3–6) mft, | 12 months—baseline |
2 | 0 | 8 | −1 | 1.99 | 0 | 1.175 | 57 | probiotic | |||||
no effect | 0.015 | p = 0.931 | 5 | 0 | 13 | 0 | 4.05 | 1 | 3.157 | 70 | control | d(ICDAS 4–6) mft, baseline | |
6 | 0 | 14 | 0 | 4.41 | 1 | 3.544 | 57 | probiotic | |||||
small | 0.278 | p = 0.11 | 10 | 0 | 21 | 0 | 6.29 | 5.5 | 6.214 | 70 | control | d(ICDAS 4–6) mft, | 12 months |
8 | 0 | 14 | 0 | 5.08 | 2 | 4.351 | 57 | probiotic | |||||
intermediate | 0.697 | p < 0.001 | 6 | 0 | 12 | −3 | 3.49 | 2 | 3.057 | 70 | control | Δ d(ICDAS 4–6) mft, | 12 months—baseline |
1 | 0 | 8 | −6 | 2.01 | 0 | 0.807 | 57 | probiotic |
NNT (Harm or Benefit) | Absolute Risk AR (95% CI) | ARR or ARI | Relative Risk RR (95% CI) | Prevented Fraction (PF) | Odds Ratio OR | (95% CI) | Binominal Proportions Test | Control Group | Probiotic Group | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
70 | 57 | n | |||||||||||||
NNT (Benefit) = 114 | 0.88% | (−16.61%, 18.36%) | 0.9825 | (0.6902, 1.3985) | p = 0.92 | 3% | 0.9655 | (0.4797, 1.9432) | p = 0.92 | p = 0.92 | 35 | −50% | 28 (49,12%) | ICDAS 1–6 > 0, baseline, n (%) | |
NNT (Benefit) = 6.74 | 14.84% | (−2.25%, 31.93%) | 0.7742 | (0.5701, 1.0515) | p = 0.1013 | 46% | 0.5404 | (0.2640, 1.1062) | p = 0.092 | p = 0.09 | 46 (65.71%) | 29 (50.88%) | ICDAS 1–6 > 0. 12 months. n (%) | ||
NNT (Benefit) = 7.16 | 13.96% | (4.78%, 23.14%) | 0.1116 | (0.0149, 0.8391) | p = 0.0331 | 90% | 0.0958 | (0.012, 0.7663) | p = 0.027 | p = 0.075 | 11 (15.71%) | 1 (1.75%) | ΔICDAS 1–6 > 0. 12 months—baseline. n (%) | ||
NNT (Harm) = 147.8 | 0.68% | (−16.57%, 17.92%) | 10.163 | (0.6727, 1.5355) | p = 0.94 | 0% | 1.0282 | (0.5060, 2.0892) | p = 0.94 | p = 0.94 | 29 (41.43%) | 24 (42.11%) | ICDAS 1–2 > 0. baseline. n (%) | ||
NNT (Harm) = 10.53 | 9.50% | (−5.30%, 24.30%) | 15.115 | (0.7947, 2.8748) | p = 0.21 | 0% | 17.111 | (0.7426, 3.9425) | p = 0.21 | p = 0.21 | 13 (18.57%) | 16 (28.07%) | ICDAS 1–2 > 0. 12 months. n (%) | ||
NNT (Benefit) = 18.56 | 5.39% | (−1.54%, 12.32%) | 0.2456 | (0.0295, 2.043) | p = 0.19 | 77% | 0.2321 | (0.0263, 2.0467) | p = 0.19 | p = 0.15 | 5 (7.14%) | 1 (1.75%) | ΔICDAS 1–2 > 0. 12 months—baseline. n (%) | ||
NNT (Benefit) = 21.22 | 4.71% | (−12.70%, 22.12%) | 0.9030 | (0.6175, 1.3204) | p = 0.60 | 13% | 0.872 | (0.4098, 1.6698) | p = 0.60 | p = 0.60 | 34 (48.57%) | 25 (43.86%) | ICDAS 3–6 > 0. baseline. n (%) | ||
NNT (Benefit) = 3.23 | 30.95% | (14.35%, 47.56%) | 0.5185 | (0.3453, 0.7786) | p = 0.0015 | 72% | 0.2778 | (0.1330, 0.5801) | p = 0.0007 | p = 0.00052 | 45 (64.29%) | 19 (33.33%) | ICDAS 3–6 > 0. 12 months. n (%) | ||
NNT (Benefit) = 4.27 | 23.43% | (9.34%, 37.53%) | 0.3439 | (0.1605, 0.7365) | p = 0.006 | 75% | 0.2520 | (0.0994, 0.6386) | p = 0.0037 | p = 0.0025 | 25 (35.71%) | 7 (12.28%) | ΔICDAS 3–6 > 0. 12 months—baseline. n (%) | ||
NNT (Benefit) = 7.24 | 13.81% | (−3.21%, 30.74%) | 0.7071 | (0.4540, 1.1013) | p = 0.12 | 44% | 0.5606 | (0.2719, 1.1558) | p = 0.12 | p = 0.12 | 33 (47,14%) | 19 (33.33%) | ICDAS 4–6 > 0. baseline. n (%) | ||
NNT (Benefit) = 2.67 | 37.52% | (21.86%, 53.18%) | 0.3594 | (0.2095, 0.6168) | p = 0.0002 | 82% | 0.1886 | (0.0852, 0.4176) | p < 0.0001 | p = 0.00002 | 41 (58.57%) | 12 (21.05%) | ICDAS 4–6 > 0. 12 months. n (%) | ||
NNT (Benefit) = 2.83 | 35.39% | (23.57%, 47.21%) | 0.0472 | (0.0066, 0.3375) | p = 0.0023 | 97% | 0.0302 | (0.0039, 0.2315) | p = 0.0008 | p = 0.000001 | 26 (37.14%) | 1 | (1.75%) | Δ ICDAS 4–6 > 0, 12 months—baseline, n (%) |
Variable | B | Standard Error | p | Odds Ratio | 95% CI for Odds Ratio | |
---|---|---|---|---|---|---|
Low Limit | Upper Limit | |||||
Age | 0.176 | 0.234 | 0.451 | 1.193 | 0.754 | 1.886 |
Sex | 0.351 | 0.430 | 0.415 | 1.420 | 0.611 | 3.299 |
Group control vs. probiotic | −1.407 | 0.477 | 0.003 | 0.245 | 0.096 | 0.625 |
Variable | B | Standard Error | p | Odds Ratio | 95% CI for Odds Ratio | |
---|---|---|---|---|---|---|
Low Limit | Upper Limit | |||||
Age | 0.201 | 0.263 | 0.443 | 1.223 | 0.731 | 2.047 |
Sex | 0.270 | 0.486 | 0.579 | 1.310 | 0.505 | 3.398 |
Group control vs. probiotic | −3.533 | 1.041 | 0.001 | 0.029 | 0.004 | 0.225 |
Variable | B | Standard Error | p | Odds Ratio | 95% CI for Odds Ratio | |
---|---|---|---|---|---|---|
Low Limit | Upper Limit | |||||
Age | −0.172 | 0.450 | 0.703 | 0.842 | 0.349 | 2.034 |
Sex | −0.207 | 0.848 | 0.807 | 0.813 | 0.154 | 4.282 |
Group control vs. probiotic | 1.453 | 1.112 | 0.191 | 4.276 | 0.484 | 37.786 |
OHI-S | n | Mean | SD | Median | Q1 | Q3 | Min | Max | Friedman Test | Durbin-Conover Post Hoc Test a | |
---|---|---|---|---|---|---|---|---|---|---|---|
Control Group | Baseline | 70 | 0.88 | 0.32 | 0.80 | 0.7 | 1.0 | 0.3 | 1.7 | χ2 = 107.833 p = 0.00 | Baseline—2 weeks Baseline—3 months Baseline—12 months 2 weeks—3 months 2 weeks—12 months 3 months—12 months |
2 weeks | 70 | 0.53 | 0.21 | 0.50 | 0.3 | 0.7 | 0.20 | 1.00 | |||
3 months | 70 | 0.69 | 0.30 | 0.70 | 0.5 | 0.8 | 0.30 | 1.50 | |||
12 months | 70 | 0.78 | 0.33 | 0.70 | 0.5 | 1 | 0.30 | 1.70 | |||
Probiotic Group | Baseline | 57 | 0.79 | 0.43 | 0.70 | 0.5 | 1 | 0.2 | 2.0 | χ2= 14.9821 p = 0.002 | Baseline—2 weeks Baseline—3 months 3 months—12 months |
2 weeks | 57 | 0.67 | 0.35 | 0.60 | 0.5 | 0.8 | 0.20 | 1.50 | |||
3 months | 57 | 0.68 | 0.34 | 0.70 | 0.5 | 0.8 | 0.20 | 1.90 | |||
12 months | 57 | 0.72 | 0.31 | 0.70 | 0.5 | 0.8 | 0.30 | 2.00 |
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Staszczyk, M.; Jamka-Kasprzyk, M.; Kościelniak, D.; Cienkosz-Stepańczak, B.; Krzyściak, W.; Jurczak, A. Effect of a Short-Term Intervention with Lactobacillus salivarius Probiotic on Early Childhood Caries—An Open Label Randomized Controlled Trial. Int. J. Environ. Res. Public Health 2022, 19, 12447. https://doi.org/10.3390/ijerph191912447
Staszczyk M, Jamka-Kasprzyk M, Kościelniak D, Cienkosz-Stepańczak B, Krzyściak W, Jurczak A. Effect of a Short-Term Intervention with Lactobacillus salivarius Probiotic on Early Childhood Caries—An Open Label Randomized Controlled Trial. International Journal of Environmental Research and Public Health. 2022; 19(19):12447. https://doi.org/10.3390/ijerph191912447
Chicago/Turabian StyleStaszczyk, Małgorzata, Małgorzata Jamka-Kasprzyk, Dorota Kościelniak, Beata Cienkosz-Stepańczak, Wirginia Krzyściak, and Anna Jurczak. 2022. "Effect of a Short-Term Intervention with Lactobacillus salivarius Probiotic on Early Childhood Caries—An Open Label Randomized Controlled Trial" International Journal of Environmental Research and Public Health 19, no. 19: 12447. https://doi.org/10.3390/ijerph191912447