Data Abstraction Form-Common Data for NCL Studies

Administrative Information

1. abstractor:____________________
2. date:_________________________
3. abbreviated study citation: ________________________________________________________
   first author   journal abbr.   year   volume    pages

Study Information

1. study design: RCT non-randomized CT case-control prospective cohort
   retrospective cohort other__________________________________________________ (circle one)
2. duration of evaluation period: ______months
3. country: __________________________________
4. site type(s):   rural (<5,000)   town (5,000-20,000)   city (20,001-100,000)   urban area (<100,000)
5. intervention(s): fluoride rinse/gel fluoride varnish chlorhexidine rinse/gel (circle all that apply)
       chlorhexidine varnish sealant other___________________________________
       combination 1 ______________________________________________________
       combination 2 ______________________________________________________
6. blinding:   examiners blind subjects blind both blind no blinding/unknown
7. treatment assignment method: random-intra individual paired lesions random-individual
         random-group non-random group other ____________________

Sample Information

1. description of population sampled: ___________________________________________________
2. subject sample selection: random systematic cluster convenience specific criteria unknown
   (If specific criteria, describe)_______________________________________________________________
3. subject age: mean:____________ range: _________
4. exclusion criteria: ________________________________________________________________
5. response rate: ___________% unknown
6. sample size:
   _____number of subjects involved
   _____number of lesions included (including control lesions)
7. background prevention exposure water fluoridation school rinsing school brushing
   school/community education other________________________
   combination __________________________________________

Examiner Information

1. number of examiners: ____
2. examiner professional training: DDS DH other unknown (circle one)
3. examiner(s) had previous experience in diagnostic task: yes no unknown (circle one)
4. examiner(s) received: training calibration standardization for this study? yes no unknown

Analysis Information

1. type of analysis: intention to treat all at final exam only full participants
2. exclusion from analysis criteria: _____________________________________________________
3. compliance estimate for those included in analysis: _________% unknown

Lesions Information

1. tooth type: permanent primary both
2. tooth location: posterior anterior both
3. tooth surfaces: occlusal occlusal+ pit/fissures proximal root other____________________
4. initial precavitated lesion designation:
   detection method: radiograph visual tactile other _____________ (circle all that apply)
   criteria: ___________________________________________________________________
5. change in precavitated lesion
   assessment method: radiograph visual tactile other _____________ (circle all that apply)
   criteria for arrested/no change: ________________________________________________
   criteria for reversed:_________________________________________________________
   criteria for progressed:_______________________________________________________

Data Collection Form -- Intervention for NCL Studies

Control Information

1. control intervention: nil placebo "active" _____________________(conc___________)

Varnish Information

1. varnish type: fluoride (conc_____) chlorhexidine (conc_____)
   both (fl conc__________) (ch conc____________)
2. brand name: _____________________
3. varnish vehicle: ________________________________________________________________
4. application method:______________________________________________________________
5. application pattern/frequency: _____________________________________________________
6. application personnel: DDS DH other_________________

Gel/Rinse Information

1. gel/rinse type: fluoride (conc_____) chlorhexidine (conc_____)
   both (fl conc__________) (ch conc____________)
2. brand name: __________________________
3. delivery method:
   gel: custom tray stock tray brushing other____________________________________
   rinse: swish and swallow swish and spit other_________________________________
4. application time: _________minutes
5. application pattern/frequency: ____________________________________________________
6. application personnel: DDS DH other_________________

Sealant Information

1. brand/type: _______________________________
2. application personnel:
   background: DDS DH other______________
   previous experience: yes no unknown
   training for this intervention: yes no unknown
3. repair/replacement procedure: none as needed unknown other ___________________________

Other Intervention

1. describe: _________________________________________________________________________

Data Abstraction Form -- Results for NCL Studies

1. intra-examiner reliability: ________ not reported (fill in mean percent, kappa score, or ICC, or circle not reported)
2. inter-examiner reliability: : ________ not reported (fill in percent, kappa score, or ICC, or circle not reported)
3. subject attrition (percent lost from initial sample):
   experimental ______%
   control ___________%
   statistical test:_________________ value_______ p value_______
4. percent sites arrested/no change:
   experimental ______%
   control ___________%
   statistical test:_________________ value_______ p value_______
5. percent sites reversed:
   experimental ______%
   control ___________%
   statistical test:_________________ value_______ p value_______
6. percent sites progressed: experimental ______%
   control ___________%
   statistical test:_________________ value_______ p value_______
7. adverse reactions/harms: none __________________________________________________

Data Abstraction Form-Common Data for Diagnostic Studies

Administrative Information

1. abstractor:____________________
2. date:_________________________
3. Abbreviated study citation: ________________________________________________________
   first author   journal abbr.   year   volume   pages

Study Type

1. setting: in vivo in vitro (circle one)
2. general description of diagnostic method(s) evaluated:

Validation Information

1. method: microscopy stereomicroscopy microradiography visual other_____ (circle one)
2. validation reliability: ________ not reported (fill in %, kappa, or ICC score, or circle not reported)
3. validation criteria for caries: into enamel to DEJ into dentin cavitation other ___________

Sample Information

1. population sampled, if known (age, etc)______________________________________________
2. sample selection: random systematic cluster convenience specific criteria unknown (circle one)
   (If specific criteria, describe)____________________________________________________________
3. sample size:
   _____number of teeth included

Data Abstraction Form-Data for Radiographic Method

Radiographic Methods Information

1. film/screen type: D E CCD SPS other_________ unknown (circle one)
2. projection: bitewing periapical other__________unknown (circle one)

Criteria

1. general diagnostic criteria set cited ________________________________
2. extent of caries to be identified: into enamel to DEJ into dentin cavitation other ___________
3. special instructions to examiners :

Examiners

1. number of examiners (observers): ____
2. examiner professional training: DDS DH other unknown (circle one)
3. examiner(s) had previous experience in diagnostic task yes no unknown (circle one)
4. examiner(s) received: training calibration standardization for this study? yes no unknown
   (circle one, if yes, circle applicable activity)

Site Description

1. tooth type: permanent primary (circle one, if both are included, abstract results separately)
2. tooth location: posterior anterior (circle one, if both are included, abstract results separately)
3. tooth surfaces:
   trial A: N=___ Surfaces: occlusal occlusal+ pit/fissures, proximal root other________
   trial B: N=___ Surfaces: occlusal occlusal+ pit/fissures, proximal root other________
   trial C: N=___ Surfaces: occlusal occlusal+ pit/fissures, proximal root other________
4. caries prevalence in sample (as determined by the validation method. Express in units used in the analysis, i.e., percent of surfaces examined. Report for level of caries being identified)
   trial A: _____ unreported
   trial B: _____ unreported
   trial C: _____ unreported

Results

1. intra-examiner reliability: ________ not reported (fill in mean percent or kappa score, or circle not reported)
2. inter-examiner reliability: : ________ not reported (fill in percent or kappa score, or circle not reported)
3. mean (across examiners) sensitivity:
   trial A: _____
   trial B: _____
   trial C: _____
4. mean (across examiners) specificity:
   trial A: _____
   trial B: _____
   trial C: _____
5. adverse reactions/harms: none __________________________________________________

Data Abstraction Form-Data for Conductance Method

Instrument

1. machine: Vanguard ECM I ECM II Caries Meter L other_________ (circle one)

Criteria

1. extent of caries to be identified: into enamel to DEJ into dentin cavitation other ___________
2. general approach to setting criteria for classification: ________________________________
3. special instructions to examiners :

Examiners

1. number of examiners (observers): ____
2. examiner professional training: DDS DH other unknown (circle one)
3. examiner(s) had previous experience in diagnostic task yes no unknown (circle one)
4. examiner(s) received: training calibration standardization for this study? yes no unknown (circle one, if yes, circle applicable activity)

Site Description

1. tooth type: permanent primary (circle one, if both are included, abstract results separately)
2. tooth location: posterior anterior (circle one, if both are included, abstract results separately)
3. tooth surfaces:
   trial A: N=___ Surfaces: occlusal occlusal+ pit/fissures, proximal root other________
   trial B: N=___ Surfaces: occlusal occlusal+ pit/fissures, proximal root other________
   trial C: N=___ Surfaces: occlusal occlusal+ pit/fissures, proximal root other________
4. caries prevalence in sample (as determined by the validation method. Express in units used in the analysis, i.e., percent of surfaces examined. Report for level of caries being identified)
   trial A: _____ unreported
   trial B: _____ unreported
   trial C: _____ unreported

Results

1. intra-examiner reliability: ________ not reported (fill in mean percent or kappa score, or circle not reported
2. inter-examiner reliability: : ________ not reported (fill in percent or kappa score, or circle not reported)
3. mean (across examiners) sensitivity:
   trial A: _____
   trial B: _____
   trial C: _____
4. mean (across examiners) specificity:
   trial A: _____
   trial B: _____
   trial C: _____
5. adverse reactions/harms: none __________________________________________________

Data Abstraction Form-Data for Visual-Tactile Method

General Method

1. probe used: yes no (circle one)
2. probe description:

Criteria

1. general diagnostic criteria set cited ________________________________
2. extent of caries to be identified: into enamel to DEJ into dentin cavitation other ___________
3. special instructions to examiners :

Examiners

1. number of examiners (observers): ____
2. examiner professional training: DDS DH other unknown (circle one)
3. examiner(s) had previous experience in diagnostic task yes no unknown (circle one)
4. examiner(s) received: training calibration standardization for this study? yes no unknown (circle one, if yes, circle applicable activity)

Site Description

1. tooth type: permanent primary (circle one, if both are included, abstract results separately)
2. tooth location: posterior anterior (circle one, if both are included, abstract results separately)
3. tooth surfaces:
   trial A: N=___ Surfaces: occlusal occlusal+ pit/fissures, proximal root other________
   trial B: N=___ Surfaces: occlusal occlusal+ pit/fissures, proximal root other________
   trial C: N=___ Surfaces: occlusal occlusal+ pit/fissures proximal root other________
4. caries prevalence in sample (as determined by the validation method. Express in units used in the analysis, i.e., percent of surfaces examined. Report for level of caries being identified)
   trial A: _____ unreported
   trial B: _____ unreported
   trial C: _____ unreported

Results

1. intra-examiner reliability: ________ not reported (fill in mean percent or kappa score, or circle not reported)
2. inter-examiner reliability: : ________ not reported (fill in percent or kappa score, or circle not reported)
3. mean (across examiners) sensitivity:
   trial A: _____
   trial B: _____
   trial C: _____
4. mean (across examiners) specificity:
   trial A: _____
   trial B: _____
   trial C: _____
5. adverse reactions/harms: none __________________________________________________