Sbu • Statens beredning för medicinsk utvärdering The Swedish Council on Technology Assessment in Health Care
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Author Year, reference Country Type of study Blin- ding Num- ber of obser- vers Obser- ver relia- bility Popu- lation Caries preval- ence and type of lesions Number of indivi- duals Number of teeth Drop- out/ missing data Com- parison method Out- come meas- ure Results enamel caries Results dentine caries (CI) Study quality and relevance Comments Clinical studies Occlusal Hintze et al 1998 [2] Denmark
Vali- dity
Yes 4 Kappa Inter: 0.14–
0.26 Dental
students 7% cavi-
tated 53 sub-
jects, 338 surfaces
52 surfaces
Separation and visual inspection Se, Sp,
NPV, PPV
Se: 4% (1–28)
Sp: 99% (97–100)
NPV: 94% PPV: 33%
Medium 0 and 8% CI = Confidence interval; NPV = Negative predictive value; PPV = Positive predictive value; Se = Sensitivity; Sp = Specificity
181 K A P I T E L 4 • d I A g n o s T I K Author Year, reference Country Type of study Blin- ding Num- ber of obser- vers Obser- ver relia- bility Popu- lation Caries preval- ence and type of lesions Number of indivi- duals Number of teeth Drop- out/ missing data Com- parison method Out- come meas- ure Results enamel caries Results dentine caries (CI) Study quality and relevance Comments Clinical studies Occlusal Hintze et al 1998 [2] Denmark
Vali- dity
Yes 4 Kappa Inter: 0.14–
0.26 Dental
students 7% cavi-
tated 53 sub-
jects, 338 surfaces
52 surfaces
Separation and visual inspection Se, Sp,
NPV, PPV
Se: 4% (1–28)
Sp: 99% (97–100)
NPV: 94% PPV: 33%
Medium Se varied between 0 and 8%
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 182
Table 4.3.4 List of included studies with DIAGNOdent. Author Year, reference Country Type of study Blin- ding Num- ber of obser- vers Observer reliability Population Caries prevalence and type of lesions Number of indi- viduals Number of teeth Drop- out/ missing data Com- parison method Out- come mea- sure Results enamel caries (CI) Results dentine caries Study quality and relevance Comments Clinical studies Primary teeth Rocha et al 2003 [4] Brazil
Validity, relia-
bility Yes
2 Kappa Intra mean: 66% Inter mean: 61% 10–11 yrs, molars under ex- foliation or extracted for ortho- dontic
reasons 21 (42%) sound 16 (32%) D1 6 (12%) D2 5 (10%) D3 2 (4%) D4 29 subjects 30 teeth
50 sites Not
reported Histology Se, Sp, accuracy
Se: 60% (45–74)
Sp: 90% (78–96)
Accuracy: 0.73
Se: 73% Sp: 95%
Accuracy: 0.90
Medium Occlusal Angnes et al 2005 [5] Brazil
Validity Partly
2 Kappa: 53% Adult volunteers, 3rd molars for extrac- tion
20 (18%) sound 24 (22%) D1 50 (45%) D2 14 (13%) D3 2 (2%) D4 38 indivi- duals, 57 teeth, 110 sites Not
reported Hemi-
section, histology Se, Sp –
Sp: 55% Medium
Limited to 3rd molars Reis et al 2006 [6]
Brazil Validity
Partly 2 Kappa: 57% In vivo/ in vitro Intra: 0.28 Inter: 0.28 Adult
volunteers, 3rd molars for extrac- tion
20 (18%) sound 24 (22%) D1 50 (45%) D2 14 (13%) D3 2 (2%) D4 38 indivi- duals, 57 teeth, 110 sites Not
reported Hemi-
section, histology Se, Sp, accuracy
Se: 80% Sp: 43%
Accuracy: 0.65
Se: 75% Sp: 52%
Accuracy: 0.82
Medium Same
material as Angnes et al, 2005 [5]
Kordic et al 2003 [3] Switzerland Validity Yes
4 Kappa:
60–75% 10–38 yrs, premolars and molars 21% sound 61% enamel 18% dentine 61 teeth
Not reported
SEM, quantita- tive image analysis
Se, Sp, ROC,
accuracy, PPV,
NPV Se: 95%
Sp: 52% PPV: 0.33 NPV: 0.98 Se: 91%
Sp: 76% PPV: 0.40 NPV: 0.98 High
CI = Confidence interval; D1 = Enamel caries; D2 = Caries to the enamel-dentine junction; D3 = Caries reaching not more than half of the dentine; D4 = Caries reaching more than half of the dentine; NPV = Negative predictive value; PPV = Positive predictive value; ROC = Receiver operating characteristic; SEM = Scanning electron microscope; Se = Sensitivity; Sp = Specificity
183 K A P I T E L 4 • d I A g n o s T I K Author Year, reference Country Type of study Blin- ding Num- ber of obser- vers Observer reliability Population Caries prevalence and type of lesions Number of indi- viduals Number of teeth Drop- out/ missing data Com- parison method Out- come mea- sure Results enamel caries (CI) Results dentine caries Study quality and relevance Comments Clinical studies Primary teeth Rocha et al 2003 [4] Brazil
Validity, relia-
bility Yes
2 Kappa Intra mean: 66% Inter mean: 61% 10–11 yrs, molars under ex- foliation or extracted for ortho- dontic
reasons 21 (42%) sound 16 (32%) D1 6 (12%) D2 5 (10%) D3 2 (4%) D4 29 subjects 30 teeth
50 sites Not
reported Histology Se, Sp, accuracy
Se: 60% (45–74)
Sp: 90% (78–96)
Accuracy: 0.73
Se: 73% Sp: 95%
Accuracy: 0.90
Medium Occlusal Angnes et al 2005 [5] Brazil
Validity Partly
2 Kappa: 53% Adult volunteers, 3rd molars for extrac- tion
20 (18%) sound 24 (22%) D1 50 (45%) D2 14 (13%) D3 2 (2%) D4 38 indivi- duals, 57 teeth, 110 sites Not
reported Hemi-
section, histology Se, Sp –
Sp: 55% Medium
Limited to 3rd molars Reis et al 2006 [6]
Brazil Validity
Partly 2 Kappa: 57% In vivo/ in vitro Intra: 0.28 Inter: 0.28 Adult
volunteers, 3rd molars for extrac- tion
20 (18%) sound 24 (22%) D1 50 (45%) D2 14 (13%) D3 2 (2%) D4 38 indivi- duals, 57 teeth, 110 sites Not
reported Hemi-
section, histology Se, Sp, accuracy
Se: 80% Sp: 43%
Accuracy: 0.65
Se: 75% Sp: 52%
Accuracy: 0.82
Medium Same
material as Angnes et al, 2005 [5]
Kordic et al 2003 [3] Switzerland Validity Yes
4 Kappa:
60–75% 10–38 yrs, premolars and molars 21% sound 61% enamel 18% dentine 61 teeth
Not reported
SEM, quantita- tive image analysis
Se, Sp, ROC,
accuracy, PPV,
NPV Se: 95%
Sp: 52% PPV: 0.33 NPV: 0.98 Se: 91%
Sp: 76% PPV: 0.40 NPV: 0.98 High
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 184
Table 4.3.5 List of included studies with ECM. Author Year, reference Country Type of study Blin- ding Num- ber of obser- vers Observer reliability Popu- lation Caries prevalence and type of lesions Number of indi- viduals Number of teeth Drop- out/ missing data Met- hod or tech- nique Com- parison method Out- come meas- ure Results enamel caries Results dentine caries Study quality and rel- evance Com- ments Clinical study Ie et al
1995 [10] The Nether- lands Validity
Not repor-
ted 2
Inter: 0.76 5–15 yrs, patients at a depart- ment of pediatric dentistry Not reported 50 sub- jects
2 sub- jects
ECM Clinical excava- tion,
sound/ enamel,
dentine ROC,
Se, Sp, A z – Se: 77%
Sp: 62% Medium
Studies on extracted teeth Occlusal Ekstrand et al 1997 [9]
Denmark Validity
Not repor-
ted 3
Intra: 73% Inter: 54% Extracted teeth
24% sound 13% <1/2 enamel 24% <1/3 dentine 23% <2/3 dentine 16% >2/3 dentine 80
molars and 20
premo- lars, 100 surfaces Not
repor- ted
ECM Histology, 2 obser- vers
Se, Sp, correla-
tion, % agree-
ment – Thres- hold between
score 2 (inner
enamel up to
outer 3rd of den-
tine) and score 3.
Se: 90% Sp: 85%
Medium Based
on 2 x 2
tables for any
caries: Se: 80%
95% CI 75–85)
Sp: 83% (95% CI
73–90) Kühnisch et al 2006 [11] Germany Validity, reliability Not
repor- ted
ECM: 6 CRM
(Cario- meter
800, proto-
type): 4 Kappa ECM Intra: 69% Inter: 62%
Intra: 79% Inter: 74% Extracted teeth 13 (11%) sound 47 (40%) D1+D2
36 (31%) D3 21 (18%) D4 117 extracted sound and non- cavita- ted 3rd
molars Not
repor- ted
ECM CRM
Hemisec- tion, his- tology, 1 observer consulting the other when in doubt
Se, Sp, Lin’s
concord- ance
correla- tion
coef- ficient
(CCC), ROC,
AUC –
Se: 57% Sp: 85%
CRM Se: 56%
Sp: 85% Medium
Few sound
surfaces AUC = Area under the curve; A z = Area under a ROC curve; CI = Confidence interval; CRM = Cariometer; ECM = Electronic caries measurement, electrical conductance measurements; ROC = Receiver operating characteristic; Se = Sensitivity; Sp = Specificity
185 K A P I T E L 4 • d I A g n o s T I K Author Year, reference Country Type of study Blin- ding Num- ber of obser- vers Observer reliability Popu- lation Caries prevalence and type of lesions Number of indi- viduals Number of teeth Drop- out/ missing data Met- hod or tech- nique Com- parison method Out- come meas- ure Results enamel caries Results dentine caries Study quality and rel- evance Com- ments Clinical study Ie et al
1995 [10] The Nether- lands Validity
Not repor-
ted 2
Inter: 0.76 5–15 yrs, patients at a depart- ment of pediatric dentistry Not reported 50 sub- jects
2 sub- jects
ECM Clinical excava- tion,
sound/ enamel,
dentine ROC,
Se, Sp, A z – Se: 77%
Sp: 62% Medium
Studies on extracted teeth Occlusal Ekstrand et al 1997 [9]
Denmark Validity
Not repor-
ted 3
Intra: 73% Inter: 54% Extracted teeth
24% sound 13% <1/2 enamel 24% <1/3 dentine 23% <2/3 dentine 16% >2/3 dentine 80
molars and 20
premo- lars, 100 surfaces Not
repor- ted
ECM Histology, 2 obser- vers
Se, Sp, correla-
tion, % agree-
ment – Thres- hold between
score 2 (inner
enamel up to
outer 3rd of den-
tine) and score 3.
Se: 90% Sp: 85%
Medium Based
on 2 x 2
tables for any
caries: Se: 80%
95% CI 75–85)
Sp: 83% (95% CI
73–90) Kühnisch et al 2006 [11] Germany Validity, reliability Not
repor- ted
ECM: 6 CRM
(Cario- meter
800, proto-
type): 4 Kappa ECM Intra: 69% Inter: 62%
Intra: 79% Inter: 74% Extracted teeth 13 (11%) sound 47 (40%) D1+D2
36 (31%) D3 21 (18%) D4 117 extracted sound and non- cavita- ted 3rd
molars Not
repor- ted
ECM CRM
Hemisec- tion, his- tology, 1 observer consulting the other when in doubt
Se, Sp, Lin’s
concord- ance
correla- tion
coef- ficient
(CCC), ROC,
AUC –
Se: 57% Sp: 85%
CRM Se: 56%
Sp: 85% Medium
Few sound
surfaces 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 186
Table 4.3.6 Studies with low quality and relevance. Yüklə 4,3 Mb. Dostları ilə paylaş:
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