Sbu • Statens beredning för medicinsk utvärdering The Swedish Council on Technology Assessment in Health Care
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- Author Year, reference Country Study design Blinding
- Baseline prevalence Type of lesions studied Diagnostic criteria Drop-out
- Results Study quality and relevance Comments
- Author, year, reference Main reason for exclusion
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Study quality and relevance Comments Brailsford et al 2002 [18] United Kingdom
RCT Double blind No reliability test
Elderly people from 12 residential homes with root caries
N: 121 Female/Male I: 35/17
C: 30/20 Mean age I: 85.6±1.3 years C: 79.8±1.4 years Mean no of: Soft lesions I: 0.88±0.20 C: 0.52±0.25
I: 1.98±0.30 C: 1.74±0.16
I: 0.08±0.05 C: 0.10±0.05
I: 4.04±0.42 C: 3.12±0.55 19 missing data, 24 too ill or died during observation period 36%
I: F-varnish (Fluor-Protec- tor) + antimi- crobial varnish 1% CHX (Cer- vitec)
C: F-varnish (Fluor-Protec- tor) + placebo varnish.
6, 13, 26, and 39-week inter- vals 1 year
Changes in lesion texture Better
I: 42% of lesions
C: 30% of lesions
NS Low
No detailed information on status of lesions after 1 year. Large drop-out rate can be accep- ted for these patients Holmes
2003 [19] United
Kingdom RCT of
paired lesions
Double blind Reliability test N: 89 Sex not stated Mean age: 70.8±6 years Two leathery lesions each 2 leathery lesions on root surface 2 moved out
2% All subjects: oral hygiene and diet instructions I: Ozone 40 sec C: Sham ozone 40 sec. All subjects: rematerializing solution
18 months
Changes in lesion texture I: 100%
reversed to hard lesions C: 1% re- versed
p<0.01 Low
Contradictory results in an unpublished follow-up (abstract)
345 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 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 Study quality and relevance Comments Brailsford et al 2002 [18] United Kingdom
RCT Double blind No reliability test
Elderly people from 12 residential homes with root caries
N: 121 Female/Male I: 35/17
C: 30/20 Mean age I: 85.6±1.3 years C: 79.8±1.4 years Mean no of: Soft lesions I: 0.88±0.20 C: 0.52±0.25
I: 1.98±0.30 C: 1.74±0.16
I: 0.08±0.05 C: 0.10±0.05
I: 4.04±0.42 C: 3.12±0.55 19 missing data, 24 too ill or died during observation period 36%
I: F-varnish (Fluor-Protec- tor) + antimi- crobial varnish 1% CHX (Cer- vitec)
C: F-varnish (Fluor-Protec- tor) + placebo varnish.
6, 13, 26, and 39-week inter- vals 1 year
Changes in lesion texture Better
I: 42% of lesions
C: 30% of lesions
NS Low
No detailed information on status of lesions after 1 year. Large drop-out rate can be accep- ted for these patients Holmes
2003 [19] United
Kingdom RCT of
paired lesions
Double blind Reliability test N: 89 Sex not stated Mean age: 70.8±6 years Two leathery lesions each 2 leathery lesions on root surface 2 moved out
2% All subjects: oral hygiene and diet instructions I: Ozone 40 sec C: Sham ozone 40 sec. All subjects: rematerializing solution
18 months
Changes in lesion texture I: 100%
reversed to hard lesions C: 1% re- versed
p<0.01 Low
Contradictory results in an unpublished follow-up (abstract)
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 346
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 Study quality and relevance Comments Johnson et al 2003 [16] Sweden
RCT No No reliability test N: 15
Female/Male: 10/5 Age: 67.5±14.1 years Superficial active primary root caries lesion 56 lesions in total according to inclusion criteria. Somewhat softe- ned lesion with a dull surface (Grade 2) 3 died
(20%) I1: Professional tooth cleaning, tap water with eucalyptus oil (n=5)
I2: Professional tooth clea- ning, 1% CHX thymol varnish (Cervitec) (n=5)
I3: Profes- sional tooth cleaning, CHX thymol varnish (Cervitec), 0.1% F-varnish (Fluor-Protec- tor) (n=4) 1 year Progression/ No progres- sion
No statist- ically sign differences between
groups but most patients could be kept free of caries progression Low
Pilot study Paraskevas et al 2004 [17] The Nether- lands
RCT Records of pre- vious examina- tions were not available to the examiner at the time of reexamination No reliability test
N: 80 After drop out: I: 33 (25 female/ 8 male)
Mean age: 48 years
C: 38 (25 female/13 male) Mean age: 50 years
Active root caries lesions
I: Mean 2.1 C: Mean 1.9 9 (11%) I: AmF/SnF 2
(n=33) C: NaF (n=38) 24
months Active/inac- tive root caries
Active root caries lesions I: 1.8 C: 2.2
NS Low
Small sample. Bias from restorations likely. No reproduci- bility test, 1 examiner
AmF = Amino fluoride; C = Control; CHX = Chlorhexidine; DF = Decayed filled; F = Fluor; I = Intervention; NaF = Natrium fluoride; NS = Not significant; RCT = Randomized controlled trial; SnF 2 = Tennfluoride 347 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 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 Study quality and relevance Comments Johnson et al 2003 [16] Sweden
RCT No No reliability test N: 15
Female/Male: 10/5 Age: 67.5±14.1 years Superficial active primary root caries lesion 56 lesions in total according to inclusion criteria. Somewhat softe- ned lesion with a dull surface (Grade 2) 3 died
(20%) I1: Professional tooth cleaning, tap water with eucalyptus oil (n=5)
I2: Professional tooth clea- ning, 1% CHX thymol varnish (Cervitec) (n=5)
I3: Profes- sional tooth cleaning, CHX thymol varnish (Cervitec), 0.1% F-varnish (Fluor-Protec- tor) (n=4) 1 year Progression/ No progres- sion
No statist- ically sign differences between
groups but most patients could be kept free of caries progression Low
Pilot study Paraskevas et al 2004 [17] The Nether- lands
RCT Records of pre- vious examina- tions were not available to the examiner at the time of reexamination No reliability test
N: 80 After drop out: I: 33 (25 female/ 8 male)
Mean age: 48 years
C: 38 (25 female/13 male) Mean age: 50 years
Active root caries lesions
I: Mean 2.1 C: Mean 1.9 9 (11%) I: AmF/SnF 2
(n=33) C: NaF (n=38) 24
months Active/inac- tive root caries
Active root caries lesions I: 1.8 C: 2.2
NS Low
Small sample. Bias from restorations likely. No reproduci- bility test, 1 examiner
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 348
Author, year, reference Main reason for exclusion Axelsson et al, 1987 [21] No data on progression/regression Axelsson et al, 1987 [22] Insufficient data on progression/regression Banting et al, 2000 [23] Prevention Barnes, 2005 [24] No study Baysan et al, 2001 [25] Too short follow-up (3 months) Chu et al, 2002 [26] Dentine caries Chussid, 2003 [27] No study Cloyd et al, 1997 [28] Comparing amalgam and composite Featherstone, 2003 [29] No study Ferreira et al, 2005 [30] Too short follow-up (3 months) Granath et al, 1992 [31] Observational study Gray et al, 1998 [32] Observational study Hamilton et al, 2002 [33] No data on progression/regression Holmes, 2004 [20] Abstract Kanellis, 2000 [34] Review Latta et al, 2005 [35] No study Lynch et al, 2000 [36] Same patients as Baysan et al 2001 [25] McComb, 2001 [37] Review. No data on progression/regression Mertz-Fairhurst et al, 1986 [38] Cavitating caries Mertz-Fairhurst et al, 1998 [39] Cavitating caries Mount et al, 2000 [40] No study Nicholson, 2003 [41] No study Petersson et al, 2002 [42] No data on progression/regression Powell et al, 1999 [43] Prevention Simonsen, 1991 [44] No data on progression/regression Strassler et al, 2005 [45] No study Thompson et al, 2005 [46] No study
349 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 The table continues on the next page Author, year, reference Main reason for exclusion Treasure, 2001 [47] Review Twetman et al, 1999 [48] No data on progression/regression Vanderas et al, 2003 [49] Review van Rijkom et al, 1998 [50] Prevention Wallace et al, 1993 [51] No data on progression/regression Wicht et al, 2003 [52] Too short follow-up (3 months) Wyatt et al, 2004 [53] Prevention Zickert et al, 1982 [54] No data on progression/regression Øgaard et al, 2006 [55] Too short follow-up (mean 18 months)
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 350
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