Two RCT studies have shown that sealed (resin-based sealant) occlusal surfaces of primary molars have fewer new or progressed caries lesions than occlusal surfaces received only fluoride varnish «Honkala S, ElSalhy M, Shyama M ym. Sealant versus ...»1, «Bakhshandeh A, Ekstrand K. Infiltration and sealin...»2. The quality of evidence is downgraded due to limited number of studies and participants, high risk of bias (blinding of outcome assessment) «Honkala S, ElSalhy M, Shyama M ym. Sealant versus ...»1, relatively short follow-up time, and only borderline significance in one of the two studies «Bakhshandeh A, Ekstrand K. Infiltration and sealin...»2. Extrapolated evidence from a high quality meta-analysis of sealing permanent molars may confirm the evidence «Ahovuo-Saloranta A, Forss H, Walsh T ym. Pit and f...»3. All in all, the quality of evidence is low.
Applicability of the evidence to the Finnish population is moderate.
Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
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RCT = randomized controlled trial | |||||
«Honkala S, ElSalhy M, Shyama M ym. Sealant versus ...»1 | RCT | 106 4-year-old children (the mean age 4.1 years), which had matched jaw quadrant pairs
with molar surfaces with the same ICDAS code 0-4, from two kindergartens in Kuwait. Only children whose parents/guardians gave their written consent were included. Non-co-operative children or children who were absent from the school on the day of the intervention were excluded. |
Pit and fissure sealant was compared to fluoride varnish. | Caries prevention on occlusal surfaces of primary molars. | High risk of bias because the dentist who measured the outcomes could see whether
sealant had been used. Caries was diagnosed only visually, and thus it could not be confirmed whether the initial caries lesions had progressed under the sealant. The follow-up time was only 1 year. |
«Bakhshandeh A, Ekstrand K. Infiltration and sealin...»2 | RCT | 50 children (mean age 6.51 years) from the public dental healthcare clinics in Nuuk,
Greenland, were included. The main inclusion criteria was presence of at least three primary molars with initial caries lesions on occlusal surfaces in each child. Children with systemic disease or co-operating difficulties were excluded. |
Intervention: Pit and fissure sealant + fluoride varnish Comparison: Fluoride varnish |
Prevention of caries lesion progression on occlusal surfaces of primary molars. The outcome was assessed by pairwise analyze of baseline and final bitewing radiographs. |
No specific high risk of bias. |
Reference | Comments |
«Honkala S, ElSalhy M, Shyama M ym. Sealant versus ...»1 | Participants of the study had a high caries risk |
«Bakhshandeh A, Ekstrand K. Infiltration and sealin...»2 | 50 % of the participants had low caries risk, 23 % had moderate and 27 % high risk. |
Results
Reference | Number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative risk (95 % CI) |
---|---|---|---|---|---|
Level of evidence: lowThe quality of evidence is downgraded due to limited number
of studies and participants, high risk of bias «Honkala S, ElSalhy M, Shyama M ym. Sealant versus ...»1, relatively short follow-up time and only borderline significance in the reference
«Bakhshandeh A, Ekstrand K. Infiltration and sealin...»2. I = intervention; C = comparison; CI = confidence interval |
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«Honkala S, ElSalhy M, Shyama M ym. Sealant versus ...»1 | 106 children, 158 matched upper or lower jaw quadrant pairs with 267 comparable pairs of molars. | 12 months | 28 (10.5 %) | 41 (15.4 %) | OR: 2.92 (1.82-4.71) |
«Bakhshandeh A, Ekstrand K. Infiltration and sealin...»2 | 50 children, 150 primary molar teeth (I = 50, C = 50) | 8-34 months (mean = 22 months) | 9 (19 %) | 17 (36 %) | RR: 0.53 (0.26-1.07) |