An abbreviated caries clinical trial design validated over 24 months.
Conventional caries trials last from 24 to 36 months. This study evaluated whether the previously established difference in efficacy between 1000- and 2500-ppm-fluoride dentifrices could be detected after 12 months. Caries was assessed by clinical visual assessment (CVA-simplified version of Dundee Selectable Threshold Method - DSTM), bitewing radiography, and Fiber Optic Transillumination (FOTI). Changes in status for individual surfaces were classified by means of pre-prepared matrices as 0 (unchanged), +1 (initiation or progression), or -1 (regression) and summed for each subject to yield an event score. Mean group event scores were calculated for each product. DSTM at the D(1) [enamel and dentin] threshold showed significant inter-group differences in mean event scores (p < 0.003) and D(1)MFS increment (< 0.007) at 12 months; these were confirmed at 24 months by traditional increment analysis (CVA & FOTI at the D(3) (dentin only) threshold + radiography, p < 0.03). This study confirms the validity of an abbreviated trial protocol.
Chesters
R K
RK
Unilever Dental Research, Port Sunlight, Quarry Road East, Bebington, Wirral CH63 3JW, UK. Richard.Chesters@Unilever.com
Pitts
N B
NB
Matuliene
G
G
Kvedariene
A
A
Huntington
E
E
Bendinskaite
R
R
Balciuniene
I
I
Matheson
J R
JR
Nicholson
J A
JA
Gendvilyte
A
A
Sabalaite
R
R
Ramanauskiene
J
J
Savage
D
D
Mileriene
J
J
D000293:Adolescent; D000704:Analysis of Variance; D002327:Cariostatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D004245:DMF Index; D003731:Dental Caries / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control*; D003733:Dental Caries Susceptibility; D003743:Dental Enamel / Q000473:pathology; D003793:Dental Restoration, Permanent; D003802:Dentifrices / Q000627:therapeutic use*; D003804:Dentin / Q000473:pathology; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005459:Fluorides / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D015588:Observer Variation; D016300:Radiography, Bitewing; D015203:Reproducibility of Results; D012107:Research Design; D013223:Statistics as Topic; D014081:Tooth Extraction; D014089:Tooth Remineralization; D014172:Transillumination; D016896:Treatment Outcome
D002327:Cariostatic Agents; D003802:Dentifrices; D005459:Fluorides