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Table 3 Details of accepted trials

From: Absence of carious lesions at margins of glass-ionomer cement and amalgam restorations: An update of systematic review evidence

Article

DS

Patient character-istics/potential confounders*

GIC treatment group

Amalgam treatment group

Outcome measure

Evaluation

Dentition/Teeth/Restoration

Study period

   

Type of material

BSL

N

n

LTF

Type of material

BSL

N

n

LTF

 

Criteria

Method

  

Welbury et al., 1991 [20]

01

[1]

Ketac Fil

119

51

7

68

Amalcap

119

51

11

68

Recurrent caries

USPHS

Clinical examination

Primary/Molars/Class I & II

5 years

Östlund et al., 1992 [21]

02

[2]

Chem Fil

25

10

0

15

ANA 2000

25

23

1

2

Recurrent caries

USPHS

Clinical examination

Primary/Molars/Class II

3 years

Taifour et al., 2002 [22]

03

[3]

Fuji IX/

Ketac Molar

610

475

9

135

Avalloy

425

331

11

94

Caries on margin

ART

Clinical examination

Primary/Molars/Single surface

3 years

 

04

  

478

106

4

372

 

380

84

9

296

   

Primary/Molars/Multiple surface

 

Mandari et al., 2003 [23]

05

[4]

Fuji II

223

173

3

50

ANA 2000

207

162

16

45

Recurrent caries

Modified USPHS

Clinical examination

Permanent/Molars/Single surface

6 years

Frencken et al., 2007 [24]

06

[5]

Fuji IX/

Ketac Molar

487

153

11

334

Avalloy

403

108

15

295

Caries on margin

ART

Clinical examination

Permanent/Molars/Single surface

6.3 years

Daou et al., 2009 [25]

07

[6]

Fuji IX

35

33

4

2

Permite C

38

36

1

2

Recurrent caries

USPHS

Clinical examination

Primary/Molars/Class I & II

1 year

 

08

  

35

23

3

12

 

38

21

3

17

    

2 years

Mandari et al., 2001 [27]

09

[7]

Fuji II

223

211

9

12

ANA 2000

207

196

15

11

Recurrent caries

Modified USPHS

Clinical examination

Permanent/Molars/Single surface

2 years

Yu et al., 2004 [28]

10

[8]

Fuji IX/

Ketac Molar-aplicap

45

37

0

8

GK amalgam

32

23

0

9

Recurrent caries

ART

Clinical examination

Primary/Molars/Single surface

1 year

 

11

  

45

29

0

16

 

32

18

0

14

    

2 years

Svanberg, 1992 [29]

12

[9]

Ketac Silver

18

14

0

4

Disper-salloy

18

14

3

4

Recurrent caries

SNBHW

Clinical examination

Permanent/Molars & Premolars/GIC = Tunnel/Amalgam = Class II

3 years

 

13

  

11

11

3

0

 

11

11

9

0

Caries progression

 

Probing & Bitewing

Permanent/approximal adjacent surfaces

 

Qvist et al., 1997 [26]

14

[10]

Ketac Fil

515

334

11

181

Disper-salloy

543

306

17

237

Recurrent caries

DPDHS

Clinical examination

Primary/Class I, II and III/V

3 years

 

15

  

127

105

25

22

 

127

94

47

33

Caries progression

  

Primary & permanent/approximal adjacent surfaces (sound or arrested caries)

 
 

16

  

156

120

25

36

 

183

129

47

54

Caries progression

  

Primary/approximal adjacent surfaces (carious or active lesion)

 
 

17

  

156

120

66

36

 

183

129

78

54

No caries regression

  

Primary/approximal adjacent surfaces (carious or active lesion)

 
  1. DS = Dataset number; BSL = Number of teeth at baseline; N = Number of teeth evaluated; n = Number of teeth with caries, LTF = Loss-to-follow-up; USPHS = United States Public Health Service criteria; ART = Criteria for atraumatic restorative treatment; SNBHW = Criteria according to the Swedish National Board for Health and Welfare; DPHS = Danish Public Dental Health Service criteria.
  2. * Potential confounders = Reported fluoride exposure; high-sugary diet; poor oral hygiene; high past caries experience.
  3. Patient characteristics:
  4. [1] Split-mouth trial. 76 patients, age 5 - 11 years; patients attending the Department of Child Dental Health at Newcastle Dental Hospital (UK) for routine restorative care; subjects were admitted to the trials if they required at least 1 pair of restorations in their deciduous molar dentition; paired cavities either Class I or II, if possible in the same tooth type; restoration always in different quadrants per pair; any cavity was suitable for inclusion; a cavity was excluded if it could only be satisfactory restored using a stainless steel crown; restorations placed between October 1982 and March 1987;caries removal by drill.
  5. Potential confounders reported: none.
  6. [2] Partial split-mouth trial. 56 patients, age 4-6 years regularly treated at one Public Dental Service clinic in Jönköping, Sweden who showed manifest caries lesion on the mesial surface of a 2nd primary molar; lesion not atypical or extended into buccal or lingual tooth surfaces; lesion completely surrounded by healthy enamel and should not reach the pulp; caries removal by drill;
  7. Potential confounders reported: none.
  8. [3] Parallel group trial. 835 patients, age 6-7 years from Damascus, Syria; with dentinal lesions with an opening wide enough for the smallest excavator to enter (diameter = 0.9 mm, without pulp involvement; size of restorations varied from small to large; dental caries prevalence 85%; mean dmfts and dmft scores of molars plus canines 9.0 and 4.4, respectively; GIC restorations placed after caries removal by hand excavation (ART).
  9. Potential confounders reported: High past caries experience.
  10. [4] Split-mouth trial. 152 patients from a cohort of grade 3-5 pupils, mean age 11 years in need of 2 or more restorations; from urban and rural schools near Dar es Salaam, Tanzania; selection criteria concerned dentine lesions in the occlusal surface that showed no evidence of pulpal involvement; pupils needed to have a dentine lesion present in contralateral permanent molars; infected dentine was removed with slow-speed drill and excavators or by hand excavation with use of Caridex.
  11. Potential confounders reported: none.
  12. [5] Parallel group trial. A total of 108 children of the ART group (GIC) and 84 children of the amalgam group were examined at evaluation year 6.3 - from Damascus, Syria; mean age 13.8 years; high risk for dentine lesion development (mean DMFT score 5.5); the mean DMFT and DMFS scores of the children in the ART group were 5.5 (SD 3.0) and 8.2 (SD 5.4) respectively; the mean DMFT and DMFS scores of the children in the amalgam group were 6.0 (SD 1/4 3.3) and 9.4 (SD 6.4); there was no statistically significant difference in caries scores between the children of the two groups (P > 0.05); the mean plaque score for the children in the ART and amalgam group were 1.3 (SD 0.58) and 1.2 (SD 0.52), respectively (see also [3]).
  13. Potential confounders reported: Poor oral hygiene; high past caries experience.
  14. [6] Partial split-mouth trial. 45 girls 6-8 years old from a private school (boarding and regular school) in Beirut, Lebanon; from a low socio-economic background with their first and second primary molars requiring new Class I or Class II restorations; specific criteria included vital teeth with normal appearance and morphology, and teeth with or without adjacent teeth; the children routinely (before and during study) received information and instructions to improve their oral hygiene, and had two dental examinations per year; criteria for exclusion from the study: patients having behavioural problems, patients with general health problems, patients with poor oral hygiene, molars requiring pulpotomy or pulpectomy; caries removal with drill;
  15. Potential confounders reported: none.
  16. [7] Split-mouth trial. see [4]
  17. [8] Split-mouth trial. 60 Chinese children with mean age 7.4 (SD 1.24) years; 27 boys, 33 girls in Bejing; caries removal for GIC (ART) restorations by hand excavation or drill.
  18. Potential confounders reported: none.
  19. [9] Split-mouth trial. 18 caries-active patients, aged 13-16 years; from the regular clientele visiting one of the dental clinics of the Public Dental Health Service in Kronoberg, Sweden; with proximal primary, early carious lesions on contralateral posterior teeth needed restorative treatment; lesion extending into dentin; have progressed into deeper zone since preceding information; caries removal by drill.
  20. Potential confounders reported: none.
  21. [10] Partial split-mouth trial. 666 children, from 3 to 13 years of age within the Danish Public Dental Health Service in the municipalities of Vaerløse and Hillerød, Denmark. The caries experience among children and adolescents in the two municipalities is below the national average; caries removal by drill.
  22. Potential confounders reported: Low past caries experience