title: Effects of 0.12% chlorhexidine gluconate on experimental gingivitis in non-human primates: clinical and microbiological alterations.
abstract: OBJECTIVE
  This study examined the efficacy of 0.12% chlorhexidine gluconate (Peridex) to reduce gingival inflammation in the absence of mechanical hygiene and its effect on the oral microbial ecology in a non-human primate (NhP) model of gingivitis.
  
  
  METHODS
  Twelve NhP were stratified based on existing inflammation into two groups of six NhP per group. Oral hygiene was performed on both groups so as to reach a level of gingival health (BOP < or = 0.3) at the conclusion of the hygiene phase. One group received 30 ml of 0.12% chlorhexidine gluconate twice daily 7 days/week, and a second group received 30 ml of placebo (distilled water colored to match the active) using the same regimen for 10 weeks. MEASUREMENT OUTCOMES: Clinical parameters including plaque (PLI), pocket depth (PD), attachment level (AL), and bleeding on probing (BOP) were evaluated at 2-week intervals. Subgingival plaque samples were collected by paper point at 2-week intervals and cultured for predominant cultivable bacteria.
  
  
  RESULTS
  By week 2, there was a difference in BOP between the groups, which reached statistical significance by week 4. This difference in BOP was maintained throughout the course of the study. Chlorhexidine gluconate (0.12%) had no significant effect on PLI, PD, or AL; although PD was greater in the placebo group after week 2 and throughout the study. Microbiologically, at week 4, the treatment group had a reduction in total bacterial counts, as well as Gram positive bacteria, and total black pigmented bacteria, compared to the placebo group. However, only the differences in Actinomyces spp. reached significance. Interestingly, when both groups received only one treatment/day on the weekends (i.e., day 6 and 7), an associated loss of statistically significant differences between the two groups was observed. Additional experiments dosing the non-human primates once daily, 5 days/week yielded no significant differences in clinical parameters, including bleeding, when compared with the placebo group.
  
  
  CONCLUSIONS
  Non-human primates provided a model system of gingivitis for testing antimicrobial agent effects on the subgingival ecology and accompanying inflammatory responses. Chlorhexidine gluconate (0.12%), even in the absence of mechanical hygiene, was effective in inhibiting clinical signs of inflammation, associated with alterations in the subgingival microbial ecology, most notably Actinomyces spp.
authors.affiliation: Department of Periodontics, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78284, USA.
authors.forename: D
authors.initials: D
authors.lastname: Cappelli
authors.forename: S C
authors.initials: SC
authors.lastname: Holt
authors.forename: R E
authors.initials: RE
authors.lastname: Singer
authors.forename: H M
authors.initials: HM
authors.lastname: Pickrum
authors.forename: J L
authors.initials: JL
authors.lastname: Ebersole
mesh_terms: D000190:Actinomyces / Q000145:classification / Q000187:drug effects; D000818:Animals; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D001419:Bacteria / Q000187:drug effects; D016009:Chi-Square Distribution; D002710:Chlorhexidine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D015169:Colony Count, Microbial; D016001:Confidence Intervals; D003773:Dental Plaque / Q000382:microbiology; D003774:Dental Plaque Index; D004195:Disease Models, Animal; D004463:Ecology; D005260:Female; D005884:Gingival Hemorrhage / Q000382:microbiology / Q000517:prevention & control; D005891:Gingivitis / Q000382:microbiology / Q000517:prevention & control*; D006094:Gram-Positive Bacteria / Q000187:drug effects / Q000254:growth & development; D008252:Macaca fascicularis; D009067:Mouthwashes / Q000627:therapeutic use*; D016017:Odds Ratio; D009910:Oral Hygiene; D017622:Periodontal Attachment Loss / Q000382:microbiology / Q000517:prevention & control; D010514:Periodontal Pocket / Q000382:microbiology / Q000517:prevention & control; D010919:Placebos
chemical_list: D000891:Anti-Infective Agents, Local; D009067:Mouthwashes; D010919:Placebos; C010882:chlorhexidine gluconate; D002710:Chlorhexidine