The Effect of MI Varnish™ on Caries Increment and Dietary Habits among 6- and 12-Year-Old Children in Riga, Latvia: A 3-Year Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Trial Design
2.2. Participants
2.3. Randomization
2.4. Inclusion and Exclusion Criteria
2.5. Recruitment
2.6. Sample Size Calculations
2.7. Interventions
2.8. Blinding
2.9. Study Treatment
2.10. Assessment of Oral Hygiene
2.11. Assessment of Dietary Habits
2.12. Statistical Methods
3. Results
3.1. Flow Diagram and the Number of Analyzed Participants
3.2. Outcomes
3.2.1. Primary Outcomes
3.2.2. Secondary Outcomes
3.3. Adverse Effects
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Group 1 (n = 61) | Group 2 (n = 66) | Group 3 (n = 68) | Group 4 (n = 65) | |
---|---|---|---|---|
Male | 44.3% (n = 27) | 53% (n = 35) | 55.9% (n = 38) | 46.2% (n = 30) |
Female | 55.7% (n = 34) | 47% (n = 31) | 44.1% (n = 30) | 53.8% (n = 35) |
Group 1 (n = 48) (MI Varnish) | Group 2 (n = 48) (Control) | |||||
---|---|---|---|---|---|---|
At Baseline | At 36 Months | p Values | At Baseline | At 36 Months | p Values | |
n/c | 27.6(9.4) 95% CI [24.4, 29.6] | 28(10.28) 95% CI [25.2, 30.8] | p = 0.813 | 26.1 (7.26) 95% CI [24,28] | 27.02(9.4) 95% CI [24.4, 29.6] | p = 0.59 |
c | 6.58 (7.16) 95% CI [4.02, 7.98] | 3.15 (3.18) 95% CI [2.15, 3.85] | p < 0.001 | 5.81 (7.73) 95% CI [3.02, 6.98] | 2.23 (2.5) 95% CI [1.43, 2.57] | p = 0.001 |
f | 7.13 (5.91) 95% CI [5.59, 8.41] | 6.38 (4.7) 95% CI [4.87, 7.13] | p = 0.39 | 4.46 (4.63) 95% CI [2.87, 5.13] | 5.08 (4.5) 95% CI [3.87, 6.13] | p = 0.427 |
CARn/c | 0.08 (0.28) 95% CI [0, 0] | 0.04 (0.2) 95% CI [0, 0] | p = 0.322 | 0.21 (0.5) 95% CI [0, 0] | 0.15 (0.41) 95% CI [0, 0] | p = 0.444 |
CAR/c | 0.98(1.33) 95% CI [0.717, 1.28] | 0.1 (0.37) 95% CI [0, 0] | p < 0.001 | 0.85 (1.77) 95% CI [0.717, 1.28] | 0.19 (0.53) 95% CI [0, 0] | p = 0.012 |
DMFS | 5.02 (5.85) 95% CI [3.59, 6.41] | 13.21 (6.67) 95% CI [11.3, 14.7] | p < 0.001 | 2.65 (4.54) 95% CI [0.87, 3.13] | 10.81 (6.14) 95% CI [8.3, 11.7] | p < 0.001 |
Decayed | 4.81 (5.55) 95% CI [2.59, 5.41] | 12.17 (5.87) 95% CI [10.6, 13.4] | p < 0.001 | 2.27 (4.1) 95% CI [0.87, 3.13] | 9.44 (5.8) 95% CI [7.59, 10.4] | p < 0.001 |
F | 0.54 (2.38) 95% CI [0.434, 1.57] | 1.02 (1.91) 95% CI [0.717, 1.28] | p = 0.23 | 0.06 (0.32) 95% CI [0, 0] | 0.92 (1.69) 95% CI [0.717, 1.28] | p = 0.001 |
M | (0.00) | 0.00(0.00) | p-konst. | 0 (0) | 0.42 (2.89) 95% CI [0, 0.566] | p = 0.32 |
dfs | 36.75 (12.96) 95% CI [32.6, 39.4] | 24.04 (12.9) 95% CI [20.6, 27.4] | p = 0.214 | 33.67 (12.74) 95% CI [29.6, 36.4] | 23.88 (11.91) 95% CI [19.9, 26.1] | p = 0.002 |
d | 28.81 (12.98) 95% CI [25.1, 32.5] | 17.56 (10.39) 95% CI [14.6, 20.5] | p < 0.001 | 28.27 (10.41) 95% CI [25.3, 31.2] | 19.65 (10.09) 95% CI [16.8, 22.5] | p < 0.001 |
f | 6.81 (5.64) 95% CI [5.21, 8.41] | 5.44 (4.82) 95% CI [4.08, 6.8] | p = 0.147 | 5.38 (6.48) 95% CI [3.55, 7.21] | 4.23 (3.94) 95% CI [3.12, 5.34] | p = 0.241 |
All examined surfaces | 88.81 (8.78) 95% CI [86.3, 91.3] | 93.38 (10.82) 95% CI [90.3, 96.4] | p = 0.027 | 85.1 (11.56) 95% CI [81.8, 88.4] | 96.98 (10.98) 95% CI [93.9, 100] | p < 0.001 |
G-V index | 1.42 (0.47) 95% CI [1.29, 1.55] | 1.48 (0.47) 95% CI [1.35, 1.61] | p = 0.259 | 1.65 (0.46) 95% CI [1.52, 1.78] | 1.51 (0.41) 95% CI [1.39, 1.63] | p = 0.578 |
Teaspoons of sugar per cup of tea | 1 (0.73) 95% CI [0.793, 1.21] | 1 (0.82) 95% CI [0.768, 1.23] | p = 0.346 | 0.79 (0.76) 95% CI [0.785, 1.22] | 0.88 (0.9) 95% CI [0.717, 1.28] | p = 0.615 |
Daily number of teaspoons of sugar (“Sugar daily amount”) | 2 (2.7) 95% CI [1.43, 2.57] | 1.68 (1.7) 95% CI [1.43, 2.57] | p = 0.300 | 1.62 (1.95) 95% CI [1.43, 2.57] | 1.66 (1.9) 95% CI [1.43, 2.57] | p = 0.914 |
Daily number of cups | 1.38 (1.38) 95% CI [0.434, 1.57] | 1.11 (1.08) 95% CI [0.717, 1.28] | p = 0.143 | 1.24 (1.25) 95% CI [0.717, 1.28] | 1.04 (1.1) 95% CI [0.717, 1.28] | p = 0.323 |
Group 3 (n = 47) | (MI Varnish) | Group 4 (n = 37) | (Control) | |||
---|---|---|---|---|---|---|
At Baseline | At 36 months | p Values | At Baseline | At 36 Months | p Values | |
n/c | 38.26 (13.81) 95% CI [34.3, 42.2] | 55.09 (13.86) 95% CI [51.1, 59.1] | p < 0.001 | 30.73 (14.53) 95% CI [26.1, 35.4] | 46.73 (11.28) 95% CI [43.1, 50.4] | p < 0.001 |
c | 3.64 (4.91) 95% CI [2.24, 5.04] | 2.77 (2.86) 95% CI [1.95, 3.59] | p = 0.177 | 1.95 (2.32) 95% CI [1.2, 2.7] | 2.22 (4.02) 95% CI [0.92, 3.52] | p = 0.643 |
f | 6.38 (7.47) 95% CI [4.24, 8.52] | 10.45 (14.49) 95% CI [6.31, 14.6] | p = 0.001 | 3.7 (3.66) 95% CI [2.52, 4.88] | 5.49 (4.81) 95% CI [3.94, 7.04] | p = 0.003 |
CARn/c | 0.57 (1.23) 95% CI [0.218, 0.922] | 0.81(1.44) 95% CI [0.398, 1.22] | p = 0.11 | 0.32 (0.63) 95% CI [0.117, 0.523] | 0.32 (0.71) 95% CI [0.091, 0.549] | p = 1.000 |
CAR/c | 0.34 (0.84) 95% CI [0.1, 0.58] | 0.21 (0.81) 95% CI [0.0, 0.442] | p = 0.429 | 0.16 (0.55) 95% CI [0.00, 0.337] | 0.054 (0.23) 95% CI [0.00, 0.128] | p = 0.291 |
DMFS | 48.62 (23.18) 95% CI [42, 55.3] | 70.96 (23.28) 95% CI [64.3, 77.6] | p < 0.001 | 34.73 (17.99) 95% CI [28.9, 40.5] | 54.95 (16.09) 95% CI [49.8, 60.1] | p < 0.001 |
Decayed | 41.3 (17.19) 95% CI [36.4, 46.2] | 58.89 (14.9) 95% CI [54.6, 63.1] | p < 0.001 | 31.49(16.68) 95% CI [26.1, 36.9] | 49.32 (13.71) 95% CI [44.9, 53.7] | p < 0.001 |
F | 5.92 (7.13) 95% CI [3.88, 7.96] | 10.45 (14.49) 95% CI [6.31, 14.6] | p = 0.001 | 3.24 (3.57) 95% CI [2.09, 4.39] | 5.49 (4.81) 95% CI [3.94, 7.04] | p < 0.001 |
M | 1.32 (3.29) 95% CI [0.379, 2.26] | 1.62 (4.38) 95% CI [0.37, 2.87] | p = 0.177 | 0 (0) | 0.14 (0.82) 95% CI [0.0, 0.404] | p = 0.324 |
dfs | 1.7 (4.4) 95% CI [0.44, 2.96] | 0 (0) | p = 0.011 | 2 (6.39) 95% CI [0.07, 3.93] | 0 (0) | p = 0.065 |
d | 1.45(3.91) 95% CI [0.592, 2.31] | 0 (0) | p = 0.015 | 1.51(5.3) 95% CI [0.0, 3.22] | 0 (0) | p = 0.091 |
f | 0.23 (0.76) 95% CI [0.0, 0.217] | 0 (0) | p = 0.040 | 0.49 (1.39) 95% CI [0.042, 0.938] | 0 (0) | p = 0.040 |
All examined surfaces | 116.6 (12.61) 95% CI [113, 120] | 124.92 (7.68) 95% CI [123, 127] | p < 0.001 | 113.54 (12.54) 95% CI [110, 118] | 126.19 (4.39) 95% CI [125, 128] | p < 0.001 |
G-V index | 1.62 (0.52) 95% CI [1.62, 1.62] | 1.22 (0.62) 95% CI [1.22, 1.22] | p < 0.001 | 1.56 (0.49) 95% CI [1.56, 1.56] | 1.38 (0.54) 95% CI [1.38, 1.38] | p = 0.046 |
Teaspoons of sugar per cup of tea | 1.31 (0.88) 95% CI [1.31, 1.31] | 1.16 (0.89) 95% CI [1.16, 1.16] | p = 0.371 | 1.36 (0.95) 95% CI [1.36, 1.36] | 1.17 (1.1) 95% CI [0.848, 1.49] | p = 0.51 |
Daily number of teaspoons of sugar (“Sugar daily amount”) | 2.59 (2.5) 95% CI [2.02, 3.16] | 2.16 (2.17) 95% CI [1.59, 2.73] | p = 0.296 | 2.67 (2.39) 95% CI [2.03, 3.31] | 2.86 (3.3) 95% CI [1.89, 3.83] | p = 0.571 |
Daily number of cups | 1.81(1.87) 95% CI [1.43, 2.57] | 1.32 (1.05) 95% CI [0.714, 1.30] | p = 0.125 | 1.38 (1.13) 95% CI [0.678, 1.32] | 1.5 (1.65) 95% CI [0.356, 1.64] | p = 0.703 |
Group 1 (n = 48) | (MI Varnish) | Group 2 (n = 48) | (Control) | |
---|---|---|---|---|
At Baseline (%) | At 36 Months (%) | At Baseline (%) | At 36 Months (%) | |
Snacking (p-value) | 6.25 (n = 3)—Not snacking 4.17 (n = 2)—Only fruits 89.58 (n = 43)—Sugary snacks | 8.33 (n = 4)—Not snacking 16.67 (n = 8)—Only fruits 75 (n = 36)—Sugary snacks (p = 0.106) | 6.25 (n = 3)—Not snacking 10.42 (n = 5)—Only fruits 81.25 (n = 39)—Sugary snacks | 2.08 (n = 1)—Not snacking 12.5 (n = 6)—Only fruits 85.42 (n = 41)—Sugary snacks (p = 0.275) |
Consumption of soft drinks (p-value) | 60.41 (n = 29)—Not consuming 39.59 (n = 19)—Consuming | 62.5 (n = 30)—Not consuming 37.5 (n = 18)— Consuming (p = 0.842) | 50 (n = 24)—Not consuming 50 (n = 24)—Consuming | 37.5 (n = 18)—Not consuming 62.5 (n = 30)—Consuming (p = 0.442) |
Consumption of tea (p-value) | 35.41 (n = 17)—Not consuming 10.42 (n = 5)— Without sugar 54.17 (n = 26)— With sugar | 33.33 (n = 16)—Not consuming 14.58 (n = 7)— Without sugar 52.08 (n = 25)— With sugar (p = 0.706) | 22.92 (n = 11)—Not consuming 18.75 (n = 9)— Without sugar 58.33 (n = 28)— With sugar | 22.92 (n = 11)—Not consuming 22.92 (n = 11)— Without sugar 52.02 (n = 25)— With sugar (p = 0.439) |
Daily frequency of snacking, soft drinks, and tea with sugar (“Sugar frequency”) | 29.7 (n = 14)— 0–2 times daily 45.83 (n = 22)—3–5 times daily 25 (n = 12)—>5 times daily | 43.75 (n = 21)— 0–2 times daily 41.67 (n = 20)—3–5 times daily 16.67 (n = 8)—>5 times daily | 27.08 (n = 13)— 0–2 times daily 43.75 (n = 21)—3–5 times daily 27.08 (n = 13)—>5 times daily | 27.08 (n = 13)—0–2 times daily 45.83 (n = 22)—3–5 times daily 25 (n = 12)—>5 times daily |
Group 3 (n = 47) (MI Varnish) | Group 4 (n = 37) (Control) | |||
---|---|---|---|---|
At Baseline (%) | At 36 Months (%) | At Baseline (%) | At 36 Months (%) | |
Snacking (p-value) | 4.3 (n = 2)—Not snacking 8.51 (n = 4)—Only fruits 87.23 (n = 41)—Sugary snacks | 4.3 (n = 2)—Not snacking 23.4 (n = 11)—Only fruits 72.34 (n = 34)—Sugary snacks (p = 0.066) | 2.7 (n = 1)—Not snacking 16.22 (n = 6)—Only fruits 81.08 (n = 30)—Sugary snacks | 16.22 (n = 6)—Not snacking 16.22 (n = 6)—Only fruits 67.57 (n = 25)—Sugary snacks (p = 0.223) |
Consumption of soft drinks (p-value) | 44.68 (n = 21)—Not consuming 53.22 (n = 26)—Consuming | 27.66 (n = 13)—Not consuming 72.34 (n = 34)—Consuming (p = 0.572) | 37.84 (n = 14)—Not consuming 62.16 (n = 23)—Consuming | 35.14 (n = 13)—Not consuming 64.86 (n = 24)—Consuming (p = 0.117) |
Consumption of tea (p-value) | 8.51 (n = 4)—Not consuming 14.89 (n = 7)— Without sugar 76.6 (n = 36)— With sugar | 14.89 (n = 7)—Not consuming 14.89 (n = 7)— Without sugar 70.21 (n = 33)— With sugar (p = 0.317) | 16.25 (n = 6)—Not consuming 16.25 (n = 6)— Without sugar 67.57 (n = 25)— With sugar | 16.25 (n = 6)—Not consuming 24.32 (n = 9)— Without sugar 59.46 (n = 22)— With sugar (p = 0.527) |
Daily frequency of snacking, soft drinks, and tea with sugar (“Sugar frequency”) | 23.4 (n = 11)—0–2 times daily 34.04 (n = 16)—3–5 times daily 42.56 (n = 20)—>5 times daily | 10.63 (n = 5)—0–2 times daily 59.57 (n = 28)—3–5 times daily 30 (n = 14)—>5 times daily | 24.32 (n = 9)—0–2 times daily 48.65 (n = 18)—3–5 times daily 27.02 (n = 10)—>5 times daily | 34.43 (n = 12)—0–2 times daily 37.84 (n = 14)—3–5 times daily 29.73 (n = 11)—>5 times daily |
Group 1 (n = 48) MI Varnish | Group 2 (n = 48) Control | Group 3 (n = 47) MI Varnish | Group 4 (n = 37) Control | |||||
---|---|---|---|---|---|---|---|---|
At Baseline | 36 Months | At Baseline | 36 Months | at Baseline | 36 Months | At Baseline | 36 Months | |
Caries1 and “Sugar frequency” | r = 0.321 p = 0.026 | r = 0.120 p = 0.418 | r = −0.021 p = 0.886 | r = 0.09 p = 0.529 | r = −0.030 p = 0.843 | r = −0.139 p = 0.352 | r = 0.303 p = 0.069 | r = 0.307 p = 0.065 |
Caries1 and “Sugar daily amount” | r = 0.121 p = 0.475 | r = 0.243 p = 0.147 | r = 0.099 p = 0.513 | r = −0.130 p = 0.391 | r = −0.101 p = 0.510 | r = −0.076 p = 0.620 | r = 0.022 p = 0.903 | r = 0.122 p = 0.499 |
Caries2 and “Sugar frequency” | r = 0.262 p = 0.072 | r = 0.086 p = 0.561 | r = −0.092 p = 0.532 | r = 0.030 p = 0.841 | r = −0.059 p = 0.695 | r = −0.004 p = 0.981 | r = 0.303 p = 0.069 | r = 0.307 p = 0.065 |
Caries2 and “Sugar daily amount” | r = 0.177 p = 0.293 | r = 0.256 p = 0.126 | r = 0.034 p = 0.822 | r = −0.132 p = 0.381 | r = −0.050 p = 0.743 | r = −0.015 p = 0.924 | r = 0.022 p = 0.903 | r = 0.122 p = 0.499 |
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Gudkina, J.; Amaechi, B.T.; Abrams, S.H.; Brinkmane, A.; Petrosina, E. The Effect of MI Varnish™ on Caries Increment and Dietary Habits among 6- and 12-Year-Old Children in Riga, Latvia: A 3-Year Randomized Controlled Trial. Dent. J. 2022, 10, 96. https://doi.org/10.3390/dj10060096
Gudkina J, Amaechi BT, Abrams SH, Brinkmane A, Petrosina E. The Effect of MI Varnish™ on Caries Increment and Dietary Habits among 6- and 12-Year-Old Children in Riga, Latvia: A 3-Year Randomized Controlled Trial. Dentistry Journal. 2022; 10(6):96. https://doi.org/10.3390/dj10060096
Chicago/Turabian StyleGudkina, Jekaterina, Bennett T. Amaechi, Stephen H. Abrams, Anda Brinkmane, and Eva Petrosina. 2022. "The Effect of MI Varnish™ on Caries Increment and Dietary Habits among 6- and 12-Year-Old Children in Riga, Latvia: A 3-Year Randomized Controlled Trial" Dentistry Journal 10, no. 6: 96. https://doi.org/10.3390/dj10060096