Effect of two new chlorhexidine mouthrinses on the development of dental plaque, gingivitis, and discolouration. A randomized, investigator-blind, placebo-controlled, 3-week experimental gingivitis study.
OBJECTIVE
The aim of this experimental gingivitis study was to assess the efficacy and safety of two new chlorhexidine (CHX) mouthrinses.


METHODS
Ninety volunteers participated in this investigator-blind, randomized, clinical-controlled trial in parallel groups. During the treatment period, no oral hygiene measures except rinsing with non-alcoholic 0.2% CHX or 0.2% CHX/0.055% sodium fluoride mouthrinses, a positive control, or a negative control were permitted. The primary parameter was the gingival index; the secondary parameters were plaque index, discolouration index, and bleeding on probing. Clinical examinations were conducted 14 days before the start of the study, at baseline, and after 7, 14, and 21 days. The two sample t-test, anova, and ancova were used for the statistical analysis.


RESULTS
No difference in efficacy was found between the two new CHX formulations and the positive control. On day 21, statistically significantly less gingival inflammation and plaque accumulation compared with placebo were observed. Besides discolouration and taste irritations, no adverse events were recorded.


CONCLUSIONS
The two new CHX mouthrinses were able to inhibit plaque re-growth and gingivitis. Neither the omission of alcohol nor the supplementation with sodium fluoride had weakened the clinical efficacy of CHX with respect to the analysed clinical parameters.
Lorenz
K
K
Department of Conservative Dentistry Medical Faculty, Dresden University of Technology, Dresden, Germany. kl4@rcs.urz.tu-dresden.de
Bruhn
G
G
Heumann
C
C
Netuschil
L
L
Brecx
M
M
Hoffmann
T
T
D000293:Adolescent; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage / Q000627:therapeutic use*; D002327:Cariostatic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D002710:Chlorhexidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003773:Dental Plaque / Q000517:prevention & control*; D003774:Dental Plaque Index; D005260:Female; D005500:Follow-Up Studies; D005884:Gingival Hemorrhage / Q000517:prevention & control; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000627:therapeutic use*; D010512:Periodontal Index; D010919:Placebos; D012449:Safety; D016037:Single-Blind Method; D012969:Sodium Fluoride / Q000008:administration & dosage / Q000627:therapeutic use; D013649:Taste / Q000187:drug effects; D014075:Tooth Discoloration / Q000139:chemically induced*; D016896:Treatment Outcome
D000891:Anti-Infective Agents, Local; D002327:Cariostatic Agents; D009067:Mouthwashes; D010919:Placebos; D012969:Sodium Fluoride; C010882:chlorhexidine gluconate; D002710:Chlorhexidine