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Preliminary Findings of Preliminary Findings of Systematic Review of Systematic Review of Effectiveness of Sealants Effectiveness of Sealants in Managing Caries in Managing Caries S Griffin, E Oong Oong, , S Griffin, E B Gooch, W Kohn B

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Preliminary Findings of Preliminary Findings of Systematic Review of Systematic Review of Effectiveness of Sealants Effectiveness of Sealants in Managing Caries in Managing Caries

S Griffin, E S Griffin, E Oong Oong, , B Gooch, W Kohn B Gooch, W Kohn

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SLIDE 2

Members of Expert Work Group Members of Expert Work Group

  • James Bader

James Bader, DDS, MPH; UNC School of , DDS, MPH; UNC School of Dentistry Dentistry

  • Jan Clarkson

Jan Clarkson, BDS, PhD; University of , BDS, PhD; University of Dundee School of Dentistry Dundee School of Dentistry

  • Margherita

Margherita Fontana Fontana, DDS, PhD; Indiana , DDS, PhD; Indiana University School of Dentistry University School of Dentistry

  • Dan Meyer

Dan Meyer, DDS; American Dental , DDS; American Dental Association Association

  • Gary

Gary Rozier Rozier, DDS, MPH; UNC School of , DDS, MPH; UNC School of Public Health Public Health

  • Jane

Jane Weintraub Weintraub, DDS, MPH; UCSF School , DDS, MPH; UCSF School

  • f Dentistry
  • f Dentistry
  • Domenick

Domenick Zero Zero, DDS, MS; Indiana University , DDS, MS; Indiana University School of Dentistry School of Dentistry

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SLIDE 3

Tasks Tasks

1. 1.

Develop objective, search strategy, and Develop objective, search strategy, and criteria for ordering articles* criteria for ordering articles*

2. 2.

Run search and establish criteria for first Run search and establish criteria for first screening of articles* screening of articles*

3. 3.

Screen articles and finalize abstraction Screen articles and finalize abstraction form and criteria for eligibility into body of form and criteria for eligibility into body of evidence* evidence*

4. 4.

Abstract studies and prepare preliminary Abstract studies and prepare preliminary report* report*

5. 5.

Finalize summary of evidence and Finalize summary of evidence and implications for practice implications for practice

* *Feedback from Expert Work Group Feedback from Expert Work Group

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OBJECTIVES AND OBJECTIVES AND INCLUSION CRITERIA INCLUSION CRITERIA

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Objective Objective

  • Examine the effectiveness of

Examine the effectiveness of dental sealants in managing caries dental sealants in managing caries in the pits and fissures of in the pits and fissures of permanent teeth permanent teeth

  • Preventing progression of caries

Preventing progression of caries

  • Reducing bacteria levels in

Reducing bacteria levels in lesions lesions

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Inclusion criteria Inclusion criteria

  • Cast

Cast “ “wide net wide net” ”

  • Any sealant material applied over

Any sealant material applied over carious lesion in human tooth without carious lesion in human tooth without prior removal of carious tissue prior removal of carious tissue

  • In vivo

In vivo

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SLIDE 7

SEARCH AND SEARCH AND ARTICLE RETRIEVAL ARTICLE RETRIEVAL

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SLIDE 8

Search Strategy Search Strategy

  • MEDLINE, EMBASE, and Cochrane

MEDLINE, EMBASE, and Cochrane Controlled Trial Register: 1966 to Controlled Trial Register: 1966 to June, 2005 June, 2005

  • Key search terms (NIH Caries

Key search terms (NIH Caries Consensus Conference): Consensus Conference):

  • Pit and fissure sealants

Pit and fissure sealants

  • Dental cements (not including pit

Dental cements (not including pit and fissure sealants) and fissure sealants)

  • Dental caries

Dental caries

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SLIDE 9

Search Results Search Results

  • 4000+ citations screened by 3

4000+ citations screened by 3 reviewers reviewers

  • Medline (n = 4350)

Medline (n = 4350)

  • Embase

Embase (n=71) (n=71)

  • Cochrane (n = 79)

Cochrane (n = 79)

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SLIDE 10

Screening Results Screening Results

  • 311 articles ordered and screened

311 articles ordered and screened

  • 25 qualifying studies were deemed

25 qualifying studies were deemed eligible for abstraction eligible for abstraction

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SLIDE 11

ABSTRACTION AND ABSTRACTION AND DESCRIPTION OF DESCRIPTION OF STUDIES STUDIES

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Abstraction Abstraction

  • Adopted form used in NIH Caries

Adopted form used in NIH Caries Consensus Conference Consensus Conference

  • 25 studies abstracted

25 studies abstracted

  • 2 independent reviewers

2 independent reviewers

  • Consensus reached

Consensus reached

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Final body of evidence Final body of evidence – – 22 22 studies studies

  • Caries progression

Caries progression – – 12 studies 12 studies

  • Caries progression and bacteria

Caries progression and bacteria activity activity – – 3 studies 3 studies

  • Bacteria activity

Bacteria activity – – 7 studies 7 studies

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15 studies examined caries 15 studies examined caries

  • Non comparative (n=2)

Non comparative (n=2)

  • Sealant vs. no sealant (n=12)

Sealant vs. no sealant (n=12)

  • % lesions progressing (n=10)

% lesions progressing (n=10)

  • Other outcome (n=2)

Other outcome (n=2)

  • Other comparisons (n=1)

Other comparisons (n=1)

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SLIDE 15

% Carious lesions % Carious lesions progressing progressing

  • Before after

Before after – – 4 studies 4 studies

  • Concurrent controls

Concurrent controls – – 6 studies 6 studies

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SUMMARIZING SUMMARIZING EVIDENCE EVIDENCE

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Assessing quality Assessing quality

  • Used USPSTF grading

Used USPSTF grading criteria criteria

  • “

“Good Good” ” – – meets all criteria meets all criteria

  • “

“Fair Fair” ” – – does not meet all criteria but does not meet all criteria but no fatal flaw that invalidates results no fatal flaw that invalidates results

  • “

“Poor Poor” ” – – fatal flaw fatal flaw

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Effect measure Effect measure -

  • % change in

% change in caries progression caries progression

1 g progressin lesions % g progressin lesions %

SEALED NOT SEALED

−

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SLIDE 19

Data did not support meta Data did not support meta-

  • analysis

analysis

  • Studies conducted analysis at tooth level

Studies conducted analysis at tooth level without adjusting for intra without adjusting for intra-

  • oral correlation
  • ral correlation
  • Number of subjects not reported

Number of subjects not reported

  • Studies varied in design

Studies varied in design

  • Parallel groups

Parallel groups -

  • 3

3

  • Split mouth

Split mouth -

  • 1

1

  • Parallel/split

Parallel/split -

  • 2

2

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Summary measure Summary measure

Median % reduction in caries Median % reduction in caries progression among 6 studies progression among 6 studies

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FINDINGS FINDINGS – – 6 STUDIES 6 STUDIES

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Characteristics Characteristics

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Sample size Sample size -

  • 1219 teeth

1219 teeth

Study Study #persons #persons #teeth #teeth #sites #sites

Florio Florio

31 31 98 98

  • Frenken

Frenken

NR NR 511 511

  • Gibson

Gibson

NR NR 79 79 111 111

Going Going

NR NR 67 67

  • Heller

Heller

71 71 436 436

  • M

M-

  • F

F 1986 1986

14 14 28 28

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Subjects Subjects

  • Ages ranged from 6 to 19 years

Ages ranged from 6 to 19 years

  • Background prevention exposure

Background prevention exposure

  • Water fluoridation

Water fluoridation – – Heller Heller

  • Prophylaxis every 3 months

Prophylaxis every 3 months – – Florio Florio

  • Negative control

Negative control – – Going Going

  • Not reported

Not reported – – Mertz Mertz-

  • Fairhurst

Fairhurst, , Frenken Frenken, , Gibson Gibson

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Baseline caries severity Baseline caries severity

Author; year; location Author; year; location Baseline caries Baseline caries Florio Florio; 2001; Brazil ; 2001; Brazil Non Non-

  • cavitated

cavitated Frenken Frenken; ; 1998; Zimbabwe 1998; Zimbabwe Non Non-

  • cavitated

cavitated Gibson Gibson; 1980; Canada ; 1980; Canada Non Non-

  • cavitated

cavitated Heller Heller; ; 1995; USA 1995; USA Non Non-

  • cavitated

cavitated Going; 1976; USA Going; 1976; USA Probably both Probably both Mertz Mertz-

  • Fairhurst

Fairhurst; 1986; USA ; 1986; USA Cavitated Cavitated

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Sealant material Sealant material

Studies Studies Material; repaired Material; repaired

Florio Florio

GIC: No GIC: No

Frenken Frenken

GIC; No GIC; No

Heller Heller

RB3; Yes RB3; Yes

Mertz Mertz-

  • Fairhurst

Fairhurst

RB3; NR RB3; NR

Gibson Gibson

RB2; NR RB2; NR

Going Going

RB1: No RB1: No

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Quality Quality – – “ “Fair Fair” ”

Study Study Quality score Quality score

Florio Florio Fair Fair Frenken Frenken Fair Fair Gibson Gibson Fair Fair Heller Heller Fair Fair Going Going Fair Fair Mertz Mertz-

  • Fairhurst

Fairhurst Fair Fair

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RESULTS RESULTS – – 6 6 STUDIES STUDIES

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% Caries reduction % Caries reduction

Study Study Months Months No Seal No Seal Seal Seal % % reduction reduction

M M-

  • F

F

11 11 1.00 1.00 0.29 0.29 71 71

Florio Florio

12 12 0.06 0.06 0.00 0.00 100 100

Going Going

12 12 0.19 0.19 0.07 0.07 62 62

Going Going

24 24 0.34 0.34 0.24 0.24 29 29

Gibson Gibson

30 30 0.77 0.77 0.19 0.19 76 76

Frenken Frenken

36 36 0.31 0.31 0.08 0.08 73 73

Heller Heller

60 60 0.52 0.52 0.11 0.11 79 79 Median Median 0.34 0.34 0.11 0.11 73 73

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% Reduction in caries progression % Reduction in caries progression

  • sealant material

sealant material

Material (#observations; Material (#observations; #studies) #studies) Median (range) Median (range) All (6; 7) All (6; 7) 73 (29 73 (29-

  • 100)

100) All RB (4; 5) All RB (4; 5) 71 (29 71 (29-

  • 79)

79) RB2 and RB3 (3; 3) RB2 and RB3 (3; 3) 76 (71 76 (71-

  • 79)

79) GIC (2; 2) GIC (2; 2) 87 (73 87 (73-

  • 100)

100)

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% Reduction in caries progression % Reduction in caries progression

  • time

time

Time (# studies; Time (# studies; #observations) #observations) Median (range) Median (range) All (6; 7) All (6; 7) 73 (29 73 (29-

  • 100)

100) 1 year (3; 3) 1 year (3; 3) 71 (62 71 (62-

  • 100)

100) 1 to 2 years (1; 1) 1 to 2 years (1; 1) 29 29 2 to 3 years (2; 2) 2 to 3 years (2; 2) 74 (73 74 (73-

  • 76)

76) 5 years (1; 1) 5 years (1; 1) 79 79

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% Reduction in caries % Reduction in caries progression progression

No matter how studies were grouped, No matter how studies were grouped, effect of sealants was strong and effect of sealants was strong and consistent consistent

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CONCLUSIONS CONCLUSIONS

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Limitations Limitations

  • No studies met current definitions of

No studies met current definitions of high quality high quality

  • Notable differences in sealant

Notable differences in sealant materials, study design and duration, materials, study design and duration, and study methods over time and study methods over time

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Main findings Main findings

  • Sealed lesions consistently had better

Sealed lesions consistently had better

  • utcomes than not sealed lesions
  • utcomes than not sealed lesions
  • % of sealed carious surfaces progressing

% of sealed carious surfaces progressing was low was low

  • Median reduction = 74% (30%, 100%)

Median reduction = 74% (30%, 100%)

  • Evidence for frank, cavitated lesions

Evidence for frank, cavitated lesions limited to: limited to:

  • Mertz

Mertz-

  • Fairhurst

Fairhurst: 14 persons; 28 teeth : 14 persons; 28 teeth

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Implications for practice Implications for practice

F Findings suggest that sealing non

indings suggest that sealing non-

  • cavitated lesions results in better

cavitated lesions results in better

  • utcomes than not sealing.
  • utcomes than not sealing.
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Acknowledgements Acknowledgements

  • Sylvia

Sylvia Bickley Bickley, Trials Search Coordinator , Trials Search Coordinator Cochrane Group Cochrane Group

  • Laurie Barker, Mathematical Statistician,

Laurie Barker, Mathematical Statistician, CDC CDC

  • Kari Jones, Quantitative Health Research

Kari Jones, Quantitative Health Research