Comparative efficacy of stabilized stannous fluoride/sodium hexametaphosphate dentifrice and sodium fluoride/triclosan/copolymer dentifrice for the prevention of periodontitis in xerostomic patients: a 2-year randomized clinical trial.
BACKGROUND
The primary objective of this study was to compare the efficacy of a stannous fluoride (SnF2) dentifrice relative to a positive control triclosan dentifrice for prevention of clinical attachment loss (CAL) in xerostomic patients. A secondary objective was to compare the dentifrices for root caries remineralization.


METHODS
This was a 2-year, randomized, double-masked, parallel-group study. A 0.454% SnF2/sodium hexametaphosphate dentifrice was tested versus a positive control dentifrice (sodium fluoride/0.30% triclosan/copolymer) in 440 medication-induced xerostomic adults identified in a 1-year, run-in phase (no treatment) as high risk for periodontitis and root caries. During the study phase, subjects were stratified based on gender and attachment level into two groups. Subjects brushed twice a day for 60 seconds using their assigned product. Clinical examinations including probing depth, attachment level, bleeding on probing, and root caries remineralization were performed at baseline and 1 and 2 years.


RESULTS
A total of 334 subjects were evaluable. During run-in, average CAL relative to initial examination was 1.33 mm. Probing depth increased 0.95 mm. At year 2 in the treatment phase, attachment gain was 0.77 mm for the test group and 0.79 mm for the control group versus baseline. Probing depth decreased 0.57 mm for the test group, similar to the control group (0.53 mm). These changes versus baseline were statistically significant (P <0.01) for each group. Products were not statistically significantly different from each other. Both treatments resulted in similar remineralization for root caries lesions at study completion (P = 0.40).


CONCLUSIONS
The results establish comparable benefits for the SnF2 dentifrice in preventing CAL and root caries versus the sodium fluoride/triclosan/copolymer control in xerostomic patients.
School of Dental Medicine, Tufts University, Boston, MA, USA.
Athena
A
Papas
Tao
T
He
Gianluca
G
Martuscelli
Mabi
M
Singh
Robert D
RD
Bartizek
Aaron R
AR
Biesbrock
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D002327:Cariostatic Agents / Q000627:therapeutic use*; D003802:Dentifrices / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005884:Gingival Hemorrhage / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D017622:Periodontal Attachment Loss / Q000517:prevention & control; D010514:Periodontal Pocket / Q000517:prevention & control; D010518:Periodontitis / Q000517:prevention & control*; D010710:Phosphates / Q000627:therapeutic use*; D017213:Root Caries / Q000517:prevention & control; D012969:Sodium Fluoride / Q000627:therapeutic use*; D014002:Tin Fluorides / Q000627:therapeutic use*; D014089:Tooth Remineralization / Q000379:methods; D014260:Triclosan / Q000627:therapeutic use*; D014987:Xerostomia / Q000150:complications*
D000891:Anti-Infective Agents, Local; D002327:Cariostatic Agents; D003802:Dentifrices; D010710:Phosphates; D014002:Tin Fluorides; D014260:Triclosan; D012969:Sodium Fluoride; C009285:sodium polymetaphosphate