Journal of Dental Hygiene Science : eISSN 2233-7679

Table 1

Characteristics of Included Studies

First author (year)   Methods   Participants   Intervention   Outcomes   Results
Mainwaring (1978)10)Study design: 5 arms parallel- group RCT (only 2 relevant arms used) Study duration: 3 years`2,104 subjects, aged 11∼12 years were enrolled to participate, but data on 1,718 could be included in the study. Numbers analyzed; 631 (only 2 relevant arms used)Control group (n=316)  - non-fluoride toothpaste and fluoride free gel Gel group (n=315)  - non-fluoride paste and 1.23% APF gel  - The gels were applied simultaneously to the upper and lower teeth in soft plastic tray for 4 minutes  - Semi-annual applicationDFS index assess the caries increment over the 3-year periodDFS, mean (SD) Control: 8.52 (6.59) Gel: 7.39 (5.65)
Englander (1969)20)Study design: 3-arms paralell-group RCT (only 2 relevant arms used) Study duration: 44 months500 subjects, aged 11∼14 were enrolled to participate, but data on 379 could be included in the study.Acidulated NaF gel group (n=127) Plain NaF gel group (n=115) Control group (n=137)  - 305 children had an average of 245 daily, six-minute, topical NaF treatments which were given under supervision in school.Mean new DMFT, DMFS increment during the 44-month periodDMFT, mean (SE) Gel group (n=127): 1.02 (0.19) Control (n=137): 3.23 (0.24) DMFS, mean (SE) FG (n=127): 1.83 (0.36) Control (n=137): 6.58 (0.62)
Englander (1971)12)Study design: 2-arms group RCT Study duration: 30 months896 subjects, aged 11∼15 years were enrolled to participate, but data on 557 could be included in the study.Acidulated NaF gel group (n=337) Control group (n=220) Gel group applied acidulated NaF gel drops in custom-fitted maxillary and mandibular applicators for 3 minutes, 3 times a week in school over a period 30 monthsMean new DMFS increment during the 30 months periodNew DMFS increment, mean (SE) Gel group: 0.89 (0.39) Control group: 2.25 (0.95)
Cons (1970)16)Study design: 5-arms parallel group RCT (only 2 relevant arms used) Study duration: 3 years2,100 subject, aged 6∼11 years were enrolled but data on 1,948 could be included in the study. Randomized: 1,142, 5 groups Numbers analyzed: 589 (only 2 relevant arms used; control: 311, FG: 278) Drop out: 536 Placebo controlled.Control group: placebo Fluoride group: APF 1.23% gel application Applied in soft trays for four minutes, repeated at annual intervals Prior to application: prophylaxis with pumice After treatment instruction: refrain from eating, drinking, or rinsing the mouth for 30 minutesMean net increment D(M)FT, D(M)FS For permanent teeth and first molar during the 3-year follow-up periodD(M)FT, mean (SE) Control (n=311): 1.99 (0.11) FG (n=278): 1.50 (0.10) D(M)FS, mean (SE) Control (n=311): 3.82 (0.29) FG (n=278): 3.14 (0.23)
Bryan (1970)15)Study design: 2-arms parallel group RCT Study duration: 2 yearsOf the 287 children, who were included in the study initially, 79 were not available for examination at the end of the study. Randomized: 208 Drop out: 79 Numbers analyzed: 208 No treatment controlled.Control (n=105), no treatment FG (n=103) APF 1.23% fluoride gel application Applied in rubber tray for 4 minutes After treatment instruction: refrain from eating, drinking, rinsing the mouth for 30 minutesMean dental caries increments, DMFT, DMFS For permanent teeth during the 2-year follow-up periodDMFT, mean (SD) Control (n=105): 3.63 (3.33) FG (n=103): 2.01 (2.54) DMFS, mean (SD) Control (n=105): 7.26 (4.76) FG (n=103): 4.56 (4.50)
Horowitz (1971)18)Study design: 4-arms parallel group RCT Study duration: 3 yearsThe follow-up survey included 681 of the original 1,105 Hawaiian children, aged 10∼12 years. Randomized: 1,105, 4 groups Numbers analyzed: 352 (only 2 relevant arms used) No treatment controlled.Control (n=170), no treatment FG (n=182) APF gel (1.23% fluoride ion as sodium fluoride, pH 3) application for 4 minutes, once a year. Prior to application: prophylaxis with standard abrasive (non-fluoride) After treatment instruction: refrain from eating, drinking, rinsing the mouth for 30 minutesNet mean DMFT, DMFS increment during the 3-year follow-up periodDMFT, mean (SE) Control (n=170): 3.62 (0.23) FG (n=182): 3.06 (0.22) DMFS, mean (SE) Control (n=170): 8.61 (0.61) FG (n=182): 6.51 (0.50)
DePaola (1980)8)Study design: 4-arm parallel group RCT (only 2 relevant arms used) Study duration: 2 years+1-year post-intervention period (but 1-year result used)The subjects age range 12∼14 years. Randomized: 522, 4 groups allocation Numbers analyzed: 270 (only 2 group used) Placebo controlled.Control (n=142), placebo gel FG (n=128) APF (1.23% F) gel application for 5 minutes in fitted tray, 10 consecutive application (day) Prior to application: no tooth brushing After application instruction: no information provided.Net mean DFS increment after 1-year result usedDFS, mean (SE) Control (n=142): 5.42 (0.43) FG (n=128): 5.09 (0.39)
Hagan (1985)17)Study design: 3-arm parallel group RCT (only 2 relevant arm used) Study duration: 2-yearsThe follow-up survey included 316 of the original 428 children, age range 11∼15 years. Randomized: 428, 3 groups Numbers analyzed: 211 (only 2 group used) Placebo controlled.Control (n=103), placebo gel FG (n=108) Fluoride gel (1.23% F-APF thixotropic gel) applied for 4 minutes with tray, twice a year. Prior to application: tooth cleaning (no paste/dentifrice used), after application instruction: excess saliva spitted, refrain from eating and drinking for 30 minutesMean DMFS increment during the 2-year follow-up periodDMFS, mean (SE) Control (n=103): 4.40 (0.38) FG (n=108): 3.08 (0.37)
Jiang (2005)9)Study design: 3-arm parallel group RCT (only 2 relevant arm used) Study duration: 2 yearsIn total, 661 6- to 7-year-old children from three primary schools were recruited. Randomized: 661, 3 groups Numbers analyzed: 421 (only 2 group used) No treatment controlled.Control (n=221), no treatment FG (n=200) APF gel (1.23% F, pH 3.5) applied for 4 minutes with tray, twice a year. Prior to application: no prophylaxis, dentition not dried. After application instruction: refrain from eating, drinking, rinsing the mouth for 30 minutesMean DMFS new caries increment during the 2-year follow-up periodDMFS, mean (SD) Control (n=221): 0.50 (0.87) FG (n=200): 0.38 (0.69)
Olivier (1992)13)Study design: 2 arm parallel group RCT Study duration: 2 years620 subject, aged 6 years were enrolled but data on 488 could be included in the study. Randomized: 488, 2 groups Numbers analyzed: 431 Placebo controlled. Drop out.Control (n=207), placebo FG (n=224) APF gel (1.23% F) applied for 4 minutes with tray, twice a year. Prior to application: no tooth cleaning After application instruction: refrain from eating, drinking for 30 minutes2-year mean DMFS incrementDMFS, mean (SD) Control (n=207): 3.24 (3.13) FG (n=224): 2.94 (3.09)
Shern (1976)14)Study design: 5-arm parallel group RCT (only 2-arm used) Study duration: 2 years614 subjects were assigned 5-group but data on 469 could be included after 2 years. Randomized: 614, 5 groups Numbers analyzed: n=234 (only 2-arm used) Placebo controlled. Drop out.Control (n=90), placebo (daily) FG (n=144) APF gel (1.23% F) applied for 5 minutes with custom-fitted tray (daily). Prior to application: tooth cleaning performed with rotating rubber cup with non-F abrasive paste. After application instruction: refrain from eating, drinking, rinsing the mouth for 30 minutesMean DMFS increment after 2-year follow-upDMFS, mean (SE) Control (n=90): 2.38 (0.39) FG (n=144): 2.12 (0.34)
Truin (2005)2)Study design: 2-arm parallel group RCT Study duration: 4 years1,091 subjects screened initially, but 594 subjects randomized, age range 9.5∼11.5 years old. Randomized: 594, 2 groups Numbers analyzed: 530 (ITT analyzed) Placebo controlled. Drop out.Control (n=261), placebo FG (n=269) Fluoride gel (neutral 1% NaF gel, 4,500 ppm F) applied for 4 minutes in a disposable flexible tray twice a year. Prior to application: supervised tooth brushing with fluoride toothpaste After application instruction: refrain from eating, drinking, rinsing the mouth for 30 minutesMean DMFS permanent dentition increment after 4-year follow-upDMFS, mean (SD) Control (n=261): 1.18 (2.17) FG (n=269): 0.94 (1.57)
Trubman (1973)19)Study design: 4-arms parallel group RCT (only 2 relevant arms used) Study duration: 3 years1,143 subjects enrolled but 618 participated through-out three-year period. Randomized: 1,143, 4 groups Numbers analyzed: 311 only 2 relevant arms used) Placebo controlled.Control (n=166), placebo FG (n=145), applied a fluoride gel (contained 1.23% fluoride ion from sodium fluoride with an approximate pH of 3) with flexible tray for four minutes. Prior to application: prophylaxis with non-fluoride pasteMean (SE) net increment DMFT, DMFS For all teeth and surface after 2-year, 3-year follow-up periodDMFT, mean (SE) Control (n=166): 1.67 (0.13) FG (n=145): 1.29 (0.13) DMFS, mean (SE) Control (n=166): 4.21(0.32) FG (n=145): 2.74 (0.26)
Vrbic (1974)21)Study design: 3-arm parallel group RCT (only 2-arm used) Study duration: 3 years496 subjects were randomized into 3-group, age range 10∼12 years, but data on 486 could be included after 3 years. Randomized: 496, 3 groups Numbers analyzed: 308 (only 2-arm used) Drop out.Control (n=156), no treatment FG (n=152) Topical F (4% NaF) application twice a year for 5 minutes Prior to application: all teeth were pumiced and cleaned with 3% H2O2. After application instruction: not reported3-year mean DFS, DFT all teeth incrementDFS, mean (SE) Control (n=156): 5.44 (0.21) FG (n=152): 3.76 (0.21) DFT, mean (SE) Control (n=156): 3.53 (0.16) FG (n=152): 2.50 (0.13)
Agrawal (2011)7)Study design: 2-group quasi RCT (community intervention trial) Study duration: 12 months Country: Bangalore, IndiaTwo schools randomly selected and these schools were randomly allocated into experimental group (n=137) and control group (n=127), age range 9∼16 years old. Numbers analyzed: 239 Drop out.Control (n=119), no treatment FG (n=120) APF gel application (1.23% F) interval 6 months, for 4-minutes in a disposable flexible tray. Prior to application: after cotton roll isolation, the investigator dried the teeth with compressed air, not reported for tooth cleaning.Mean DMFS, DMFT after 12-month follow-upDMFS, mean (SD) Control (n=119): 4.63 (1.48) FG (n=120): 4.32 (1.44) DMFT, mean (SD) Control (n=119): 3.66 (1.32) FG (n=120): 3.40 (1.47)
van Rijkom (2004)5)Study design: 2-arms group RCT Study duration: 4 years773 subjects, aged 4.5∼6.5 years were enrolled to participate, but data on 676 could be included in the study.Fluoride group (n=340) Control group (n=336) Fluoride group neutral 1% sodium fluoride gel (4,500 ppm fluoride ion) was applied, the placebo or fluoride gel professionally applied in flexible tray during 4 minutes, semi-annual application. After application, the participants were advised to refrain from rinsing, eating and drinking for 30 minutes.Mean DMFS, dmfs increment during the 4-year follow-up periodDMFS, dmfs increment, mean (SD) DMFS increment Fluoride group: 0.23 (0.72) Placebo group: 0.34 (0.85)
Splieth (2011)11)Study design: 2-arm groups RCT Study duration: 4 years776 subjects were enrolled but data on 579 could be included after completed study, age range 6∼8 years old. Randomized: 776, 2 groups Numbers analyzed: 579 Drop out: 197Control (n=349), no treatment FG (n=230) Topical fluoride (10,000 ppm amine fluoride) application, bi-annual Prior to application: not reported After application instruction: not reportedMean caries incidence DMFS in permanent first molar 4-year follow-up periodDMFS, mean (SD) Control (n=349): 0.78 (1.81) FG (n=230): 0.81 (1.74)

RCT: randomized controlled trial, APF: acidulated fluoride phosphate, DFS: decayed and filled surface, SD: standard deviation, D(M)FT: decayed, missing, and filled permanent teeth, D(M)FS: decayed, missing, and filled permanent tooth surface, SE: standard error, FG: fluoride group.

J Dent Hyg Sci 2019;19:9-22 https://doi.org/10.17135/jdhs.2019.19.1.9
© 2019 J Dent Hyg Sci