title: Do active ingredients in non alcoholic chlorhexidine mouth wash provide added effectiveness? Observations from a randomized controlled trial.
abstract: OBJECTIVE
  Chlorhexidine (CHX) is the most tested and leading oral antiseptic agent. Zinc as an active ingredient has shown additive and synergistic effect and when Sodium fluoride (NaF) was used it failed to show added effectiveness and the combined effect of NaF and Zinc chloride (ZnCl2) both as active ingredients has never been evaluated. The present study assessed the effectiveness of active ingredients and to compare the frequency of adverse events occurring with traditional CHX and CHX+NaF+ZnCl2.
  
  
  METHODS
  A randomized double blind crossover trial was executed with 24 subjects participating in two consecutive experimental phases of 21 days each with CHX and CHX+NaF+ZnCl2 mouth rinses. Each individual was assessed for gingivitis, plaque, supragingival calculus and extrinsic stains at baseline and after experimental phase and adverse events experienced were recorded.
  
  
  RESULTS
  There was a significant difference (p = 0.014) between the two experimental mouth rinses for their effectiveness on gingivitis. In the CHX group, the gingival score on D21 was significantly greater by 0.13 than DO while with CHX+NaF+ZnCl2 there was a decrease in gingival score by 0.09 which was insignificant. No significant difference was observed between the interventions for plaque accumulation and formation of extrinsic stains. The difference in the mean calculus score at baseline and after experimental phase was 1.47 for CHX+NaF+ZnCl2 in contrast to 1.93 among CHX group. Oral itching, oral soreness, apthous ulcers and dryness were reported by many subjects while burning sensation was reported by very few volunteers. There was no significant difference for occurrence of adverse events between the two experimental mouthrinses.
  
  
  CONCLUSIONS
  CHX+NaF+ZnCl2 mouth rinse was found to be significantly more effective in the reduction of gingivitis and supragingival calculus. No significant difference was found for the occurrence of dental plaque, extrinsic stains and adverse events between the interventions.
authors.affiliation: Vishnu Dental College, Bhimavaram, India.
authors.forename: K
authors.initials: K
authors.lastname: Santhosh
authors.forename: L
authors.initials: L
authors.lastname: Surbhi
authors.forename: T
authors.initials: T
authors.lastname: Harish
authors.forename: T
authors.initials: T
authors.lastname: Jyothi
authors.forename: T
authors.initials: T
authors.lastname: Arvind
authors.forename: D
authors.initials: D
authors.lastname: Prabu
authors.forename: K
authors.initials: K
authors.lastname: Suhas
mesh_terms: D016009:Chi-Square Distribution; D002710:Chlorhexidine / Q000009:adverse effects / Q000627:therapeutic use*; D002712:Chlorides / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003728:Dental Calculus / Q000188:drug therapy; D003773:Dental Plaque / Q000188:drug therapy; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005891:Gingivitis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D009067:Mouthwashes / Q000009:adverse effects / Q000737:chemistry* / Q000627:therapeutic use*; D012969:Sodium Fluoride / Q000009:adverse effects / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D017967:Zinc Compounds / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D002712:Chlorides; D004338:Drug Combinations; D009067:Mouthwashes; D017967:Zinc Compounds; C016837:zinc chloride; D012969:Sodium Fluoride; D002710:Chlorhexidine