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 Gooch, W Kohn
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 � of Dentistry of Dentistry � Domenick Domenick Zero Zero , DDS, MS; Indiana University , DDS, MS; Indiana University � School of Dentistry School of Dentistry
Tasks Tasks Develop objective, search strategy, and Develop objective, search strategy, and 1. 1. criteria for ordering articles* criteria for ordering articles* Run search and establish criteria for first Run search and establish criteria for first 2. 2. screening of articles* screening of articles* Screen articles and finalize abstraction Screen articles and finalize abstraction 3. 3. form and criteria for eligibility into body of form and criteria for eligibility into body of evidence* evidence* Abstract studies and prepare preliminary Abstract studies and prepare preliminary 4. 4. report* report* Finalize summary of evidence and Finalize summary of evidence and 5. 5. implications for practice implications for practice *Feedback from Expert Work Group Feedback from Expert Work Group *
OBJECTIVES AND OBJECTIVES AND INCLUSION CRITERIA INCLUSION CRITERIA
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
Inclusion criteria Inclusion criteria Cast “ “wide net wide net” ” � Cast � � 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 �
SEARCH AND SEARCH AND ARTICLE RETRIEVAL ARTICLE RETRIEVAL
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 �
Search Results Search Results 4000+ citations screened by 3 4000+ citations screened by 3 � � reviewers reviewers Medline (n = 4350) Medline (n = 4350) � � Embase (n=71) (n=71) Embase � � Cochrane (n = 79) Cochrane (n = 79) � �
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
ABSTRACTION AND ABSTRACTION AND DESCRIPTION OF DESCRIPTION OF STUDIES STUDIES
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 �
Final body of evidence – – 22 22 Final body of evidence studies studies � Caries progression Caries progression – – 12 studies 12 studies � � Caries progression and bacteria Caries progression and bacteria � activity – – 3 studies 3 studies activity � Bacteria activity Bacteria activity – – 7 studies 7 studies �
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) �
% Carious lesions % Carious lesions progressing progressing Before after – – 4 studies 4 studies � Before after � Concurrent controls – – 6 studies 6 studies � Concurrent controls �
SUMMARIZING SUMMARIZING EVIDENCE EVIDENCE
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 �
Effect measure - - % change in % change in Effect measure caries progression caries progression % lesions progressin g − SEALED 1 % lesions progressin g NOT SEALED
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- -oral correlation oral correlation without adjusting for intra � 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 �
Summary measure Summary measure Median % reduction in caries Median % reduction in caries progression among 6 studies progression among 6 studies
– 6 STUDIES 6 STUDIES FINDINGS – FINDINGS
Characteristics Characteristics
Sample size - - 1219 teeth 1219 teeth Sample size Study #persons #teeth #sites Study #persons #teeth #sites Florio Florio 31 98 -- 31 98 -- Frenken Frenken NR 511 -- NR 511 -- Gibson Gibson NR 79 111 NR 79 111 Going Going NR 67 - NR 67 - Heller Heller 71 436 -- 71 436 -- M- -F F M 14 28 -- 14 28 -- 1986 1986
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
Baseline caries severity Baseline caries severity Author; year; location Baseline caries Author; year; location Baseline caries Florio; 2001; Brazil ; 2001; Brazil Non- -cavitated cavitated Florio Non Frenken; ; 1998; Zimbabwe 1998; Zimbabwe Non- -cavitated cavitated Frenken Non Gibson; 1980; Canada ; 1980; Canada Non- -cavitated cavitated Gibson Non Heller; ; 1995; USA 1995; USA Non- -cavitated cavitated Heller Non Going; 1976; USA Probably both Going; 1976; USA Probably both Mertz- -Fairhurst Fairhurst; 1986; USA ; 1986; USA Cavitated Mertz Cavitated
Sealant material Sealant material Studies Material; repaired Studies Material; repaired Florio Florio GIC: No GIC: No Frenken Frenken GIC; No GIC; No Heller Heller RB3; Yes RB3; Yes Mertz- - Mertz RB3; NR RB3; NR Fairhurst Fairhurst Gibson Gibson RB2; NR RB2; NR Going Going RB1: No RB1: No
Quality – – “ “Fair Fair” ” Quality Study Quality score Study Quality score Florio Fair Florio Fair Frenken Fair Frenken Fair Gibson Fair Gibson Fair Heller Fair Heller Fair Going Fair Going Fair Mertz- -Fairhurst Fairhurst Fair Mertz Fair
– 6 6 RESULTS – STUDIES STUDIES RESULTS
% Caries reduction % Caries reduction Study Months No Seal Seal % Study Months No Seal Seal % reduction reduction M- -F F M 11 1.00 0.29 71 11 1.00 0.29 71 Florio Florio 12 0.06 0.00 100 12 0.06 0.00 100 Going Going 12 0.19 0.07 62 12 0.19 0.07 62 Going Going 24 0.34 0.24 29 24 0.34 0.24 29 Gibson Gibson 30 0.77 0.19 76 30 0.77 0.19 76 Frenken Frenken 36 0.31 0.08 73 36 0.31 0.08 73 Heller Heller 60 0.52 0.11 79 60 0.52 0.11 79 Median 0.34 0.11 73 Median 0.34 0.11 73
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