Sbu • Statens beredning för medicinsk utvärdering The Swedish Council on Technology Assessment in Health Care
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Reprodu- cibility test Patient population No Sex Age Baseline prevalence Type of lesions studied Diagnostic crtieria Drop- out Intervention (I) Control (C) Obser- vation time Endpoints Results Study quality and relevance Comments Bruun et al 1985 [8] Denmark
RCT school classes
Double blind No reliability test Grades 4, 5, 6 in 4 public schools N: 359
Female/Male I1: 58/67 (after drop-out) I2: 63/63 (after drop-out) Mean age: 11 years (9–12) Mean DFS
Clinical: 5.1 Radiographic: 1.0 All surfaces and approximal surfaces Möller 1973 108 (30%)
I1: 0.2% NaF 10 ml rinsing 2 x/month + placebo varnish I2: Fluor varnish (Fluorprotector, 5% NaF) every 6th month + pla- cebo 10 ml rinsing 2 x/month 3 years
Progression or regression of approximal caries on BW No pro- gression in enamel: I1: 2.8%
I2: 1.7% (NS)
No sign difference in mean DFS increment between the groups Medium Modéer et al 1984 [13] Sweden
RCT Blinded examiner Reliability test Children in 3 schools N: 194 (after drop-out) Female/Male: 92/102
Age: 14 years I: DF 4.1 C: DF 5.3 Approximal surfaces pre- molars, molars. 15% enamel caries at baseline Radiographic: Gröndahl 1977 42 (18%)
I: 31 (26%)
C:11 (9%)
I: NaF varnish 5% every 3rd month + 0.2% NaF rinsing every 2 week C: 0.2% NaF rin- sing every 2 week 3 years 3 years
Initial caries or regression on BW
24% less progression in I com- pared to C (significant) Medium
Large drop- out rate in I; bias from non-com-
pliance and possibly from operative treatment K A R I E S – d I A G N O S T I K , R I S K B E d ö M N I N G O C H I C K E - I N vA S I v B E H A N d L I N G 338
Table 6.3 Treatment of early coronal caries lesions. Studies with low quality and relevance. Author Year, reference Country Study design Blinding Reprodu- cibility test Patient population No Sex Age Baseline prevalence Type of lesions studied Diagnostic criteria Drop-out Interven- tion (I) Control (C) Obser- vation time End- points Results Study quality and relevance Comments Brazzelli et al 2006 [15] United
Kingdom Systematic literature review
3 unpublished studies
4 abstracts – – – – I1: Ozone + reductant I2: Reductant only I3: Ozone + reductant + fissure sealant I4: Reductant + fissure sealant 6–12 months
DIAGNO- dent
ECM Reversal of caries Progres-
sion of caries
1 study showed positive signi- ficant effects on clinical severity scores, DIAGNO-
dent and ECM with ozone + reductant vs no ozone. 2 studies showed no difference between groups
Low The results are based on unpublished studies de Liefde 1987 [9] New Zealand RCT Field study Not stated No reliability test N: 444
Sex not stated Age: <10 years (76% ≤8 years). Children atten- ding selected dental clinics with erupted permanent 1st molars with occlusal initial (enamel) caries Mean dft at age 5=4.3 Occlusal surfaces permanent 1st molars
Visual-tactile, diagnostic criteria not clear Only those who completed the study included I: Application of 2% NaF solu- tion 1 x/week for 3 weeks, repeated after 3 months + application of NaF solution every 6 months C: Application of NaF solution every 6 months 2 years, 8 months New
DFS on occlusal surfaces of permanent 1st molars % not restored surfaces: I: 67%
C: 64% (NS) Low
339 K A P I T E L 6 • b E h A n d L I n g Av T I d I g A K A r I E s s K A d o r Author Year, reference Country Study design Blinding Reprodu- cibility test Patient population No Sex Age Baseline prevalence Type of lesions studied Diagnostic criteria Drop-out Interven- tion (I) Control (C) Obser- vation time End- points Results Study quality and relevance Comments Brazzelli et al 2006 [15] United
Kingdom Systematic literature review
3 unpublished studies
4 abstracts – – – – I1: Ozone + reductant I2: Reductant only I3: Ozone + reductant + fissure sealant I4: Reductant + fissure sealant 6–12 months
DIAGNO- dent
ECM Reversal of caries Progres-
sion of caries
1 study showed positive signi- ficant effects on clinical severity scores, DIAGNO-
dent and ECM with ozone + reductant vs no ozone. 2 studies showed no difference between groups
Low The results are based on unpublished studies de Liefde 1987 [9] New Zealand RCT Field study Not stated No reliability test N: 444
Sex not stated Age: <10 years (76% ≤8 years). Children atten- ding selected dental clinics with erupted permanent 1st molars with occlusal initial (enamel) caries Mean dft at age 5=4.3 Occlusal surfaces permanent 1st molars
Visual-tactile, diagnostic criteria not clear Only those who completed the study included I: Application of 2% NaF solu- tion 1 x/week for 3 weeks, repeated after 3 months + application of NaF solution every 6 months C: Application of NaF solution every 6 months 2 years, 8 months New
DFS on occlusal surfaces of permanent 1st molars % not restored surfaces: I: 67%
C: 64% (NS) Low
The table continues on the next page K A R I E S – d I A G N O S T I K , R I S K B E d ö M N I N G O C H I C K E - I N vA S I v B E H A N d L I N G 340
Table 6.3 continued Author Year, reference Country Study design Blinding Reprodu- cibility test Patient population No Sex Age Baseline prevalence Type of lesions studied Diagnostic criteria Drop-out Interven- tion (I) Control (C) Obser- vation time End- points Results Study quality and relevance Comments Forsman
1974 [10] Sweden
RCT school classes
Double blind No reliability test N: 135 in each group Female/Male I1: 44/83 (after drop-out) I2: 77/49 (after drop-out) Age: 11–12 years at baseline Mean DMFS: 4–5 Approximal surfaces Own criteria 17 (6%) I1: 0.2% NaF 10 ml rinsing 2 min 1 x/week I2: 0.025% NaF 10 ml rinsing 2 min 1 x/week 2 years
Progres- sion or no progres- sion of
enamel caries
on BW No progression in enamel I1: 67 surfaces I2: 66 surfaces (NS).
Significant effect in girls Low Aim of study was not to assess pro- gression. No statistics on progression. Small sample Gisselsson et al 1994 [14] Sweden CCT
Blinded Reliability test N: 233 (I: 59, C1: 58, C2: 116) Sex not stated Age: 4 years I: 2.59 C1: 4.53
C2: 4.20 Approximal surfaces, primary molars
Gröndahl 1984, Peyron 1992 18 (8%) I: 1% CHX gel applied by flos- sing 4 x/year C1: Placebo gel applied by flos- sing 4 x/year C2: No gel treatment All groups F- tablet 0.25 mg 1 x 1
3 years Progres-
sion of approxi-
mal caries on BW
after 2 years
I (n=9): 11/28 lesions no progression C1 (n=18): 13/66 lesions no progression p<0.05 Low
Small numbers of events Heller et al 1995 [11] USA Retrospective follow-up No
No reliability test
Children in 8 schools All children with ≥1 erupted, not restored or sealed 1st per- manent molar were included. All children who completed 5-year follow- up after fissure sealant N: 113 (I: 96, C: 17) Sex not stated. Age: 7 Mean DFS: 3.1 Occlusal surfaces permanent 1st molars Visual-tactile diagnosis; own criteria
– I: Fissure sea- lant (Delton) C: No treat- ment 5 years
New DFS on
occlusal surfaces of permanent 1st molars Sealed surfa- ces with initial caries at sealing developed manifest caries more seldom than surfaces not sealed OR: 9 Low
Retrospective Low number of children (C-group) 341 K A P I T E L 6 • b E h A n d L I n g Av T I d I g A K A r I E s s K A d o r Author Year, reference Country Study design Blinding Reprodu- cibility test Patient population No Sex Age Baseline prevalence Type of lesions studied Diagnostic criteria Drop-out Interven- tion (I) Control (C) Obser- vation time End- points Results Study quality and relevance Comments Forsman
1974 [10] Sweden
RCT school classes
Double blind No reliability test N: 135 in each group Female/Male I1: 44/83 (after drop-out) I2: 77/49 (after drop-out) Age: 11–12 years at baseline Mean DMFS: 4–5 Approximal surfaces Own criteria 17 (6%) I1: 0.2% NaF 10 ml rinsing 2 min 1 x/week I2: 0.025% NaF 10 ml rinsing 2 min 1 x/week 2 years
Progres- sion or no progres- sion of
enamel caries
on BW No progression in enamel I1: 67 surfaces I2: 66 surfaces (NS).
Significant effect in girls Low Aim of study was not to assess pro- gression. No statistics on progression. Small sample Gisselsson et al 1994 [14] Sweden CCT
Blinded Reliability test N: 233 (I: 59, C1: 58, C2: 116) Sex not stated Age: 4 years I: 2.59 C1: 4.53
C2: 4.20 Approximal surfaces, primary molars
Gröndahl 1984, Peyron 1992 18 (8%) I: 1% CHX gel applied by flos- sing 4 x/year C1: Placebo gel applied by flos- sing 4 x/year C2: No gel treatment All groups F- tablet 0.25 mg 1 x 1
3 years Progres-
sion of approxi-
mal caries on BW
after 2 years
I (n=9): 11/28 lesions no progression C1 (n=18): 13/66 lesions no progression p<0.05 Low
Small numbers of events Heller et al 1995 [11] USA Retrospective follow-up No
No reliability test
Children in 8 schools All children with ≥1 erupted, not restored or sealed 1st per- manent molar were included. All children who completed 5-year follow- up after fissure sealant N: 113 (I: 96, C: 17) Sex not stated. Age: 7 Mean DFS: 3.1 Occlusal surfaces permanent 1st molars Visual-tactile diagnosis; own criteria
– I: Fissure sea- lant (Delton) C: No treat- ment 5 years
New DFS on
occlusal surfaces of permanent 1st molars Sealed surfa- ces with initial caries at sealing developed manifest caries more seldom than surfaces not sealed OR: 9 Low
Retrospective Low number of children (C-group) The table continues on the next page K A R I E S – d I A G N O S T I K , R I S K B E d ö M N I N G O C H I C K E - I N vA S I v B E H A N d L I N G 342
BW = Bitewing radiographs; C = Control; CCT = Clinical controlled trial; CHX = Chlorhexidine; DMFS = Decayed, filled teeth; ECM = Electronic caries monitor; DEJ = Dentine enamel junction; DFS = Decayed, filled surfaces; F = Fluor; I = Intervention; NaF = Natrium fluoride; NS = Not significant; OR = Odds ratio; RCT = Randomized controlled trial
Hyde
1973 [12] Canada
RCT Blinded examiner No reliability test N: 377
Age and sex not stated Caries in pri- mary dentition. Approximal initial caries Not stated Approximal sur- faces permanent 1st molars Radiographic: own criteria 255 (67%) I1: Stannous F I2: Phosphate F I3: Silver nitrate C: Placebo (dis- tilled water) 2 years Initial
caries pro- gression to DEJ on BW Sign fewer in all I compared to C
Low Large drop- out
343 K A P I T E L 6 • b E h A n d L I n g Av T I d I g A K A r I E s s K A d o r Author Year, reference Country Study design Blinding Reprodu- cibility test Patient population No Sex Age Baseline prevalence Type of lesions studied Diagnostic criteria Drop-out Interven- tion (I) Control (C) Obser- vation time End- points Results Study quality and relevance Comments Hyde
1973 [12] Canada
RCT Blinded examiner No reliability test N: 377
Age and sex not stated Caries in pri- mary dentition. Approximal initial caries Not stated Approximal sur- faces permanent 1st molars Radiographic: own criteria 255 (67%) I1: Stannous F I2: Phosphate F I3: Silver nitrate C: Placebo (dis- tilled water) 2 years Initial
caries pro- gression to DEJ on BW Sign fewer in all I compared to C
Low Large drop- out
K A R I E S – d I A G N O S T I K , R I S K B E d ö M N I N G O C H I C K E - I N vA S I v B E H A N d L I N G 344
Table 6.4 Treatment of early root surface caries lesions. Author Year, reference Country Study design Blinding Reliability test Patient population No Sex Age Inclusion criteria Baseline prevalence Type of lesions studied Diagnostic criteria Drop-out Interven- tion (I) Control (C) Obser- vation time Endpoints Results Yüklə 4,3 Mb. Dostları ilə paylaş:
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