Triclosan Toothpaste as a Preventive Strategy of Mucositis in Smokers
Condition: Dental Implants; Cigarette Smoking
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      The purpose of this trial was to determine the effect of a triclosan-containing toothpaste in
      the clinical parameters and in the profile of osteo-immunoinflammatory mediators in the
      peri-implant crevicular fluid (PICF) as a preventive therapy of peri-implant experimental
      mucositis in cigarette smokers
    

Detailed description: 
      This study was designed as double-blind, randomized, crossover study to evaluate the
      influence of a triclosan-containing toothpaste in the profile of osteo-immunoinflammatory
      mediators in the PICF of smoker individuals and in the clinical measurements during the
      progression of experimental peri-implant mucositis. This investigation was approved by the
      ethics committee of Paulista University . Patient recruitment started in July 2013 and was
      completed by the end of September 2014. Clinical procedures and evaluations were carried out
      between September 2013 and November 2014. Data entry and statistical analyses were performed
      in April 2015. All the patients in the study were recruited from the patients referred to
      Paulista University. Patients were thoroughly informed of the nature, potential risks and
      benefits of their participation in the study, and they each signed an informed consent
      document. During this 3-week period, participants were randomly assigned to two groups by a
      computer-generated list: Triclosan (n=13): triclosan/copolymer/fluoride toothpaste or Placebo
      (n=13): fluoride toothpaste, by filling the individual silicone stent with the respective
      toothpaste, according to the experimental group, and allowing it to come into contact with
      the implant area for 2 min, three times per day. Conventional tooth brushing was performed in
      the non-stent areas.

      After 3 weeks, a professional prophylaxis was performed and a wash-out period of 30 days was
      established. All patients restarted their optimal mechanical plaque control practices to
      reach pre-experimental levels of oral cleanliness and gingival/mucosal health. Then, a second
      experimental 3-week period of undisturbed plaque accumulation around the implants was
      established and the experimental groups were exchanged. After that, a new professional
      prophylaxis was performed. Patients were blinded to the therapies.All evaluations (clinical
      and immunoenzimatic) were performed at baseline, 3, 7, 14 and 21 days of each period of
      experimental mucositis induction. Levels of osteo-immunoinflammatory mediators were
      considered primary outcome variable. The number of patients included was based on previous
      crossover investigations that found differences in the crevicular fluid levels of
      osteo-immunoinflammatory markers in different clinical status. The same examiner (SPP), who
      was blinded to the groups, performed all clinical measurements. To perform the intra-examiner
      calibration, 15 non-study individuals presenting dental implants were selected. The examiner
      measured the PD of all individuals twice within 24 hours. The intra-class correlation was
      calculated as 95% reproducibility.

      Individual stents were prepared to standardize the location of periodontal probe in order to
      evaluate the following parameters at four sites of the experimental dental implants at
      baseline, 3, 7, 14, 21 days follow-ups: 1) plaque index (PI/%): dichotomous plaque index
      along the mucosal margin around implants, 2) Bleeding on probing (BOP,%):dichotomous index of
      bleeding during probing around implants, 3) Position of the peri-implant margin (PPM/mm):
      distance from the stent to the peri-implant margin; 4) Relative clinical attachment level
      (RCAL/mm): distance from the stent to the bottom of the peri-implant pocket; and 5)
      Peri-implant Probing depth (PD,mm): calculated by deducting PPM from RCAL.

      Levels of interferon, interleukin (IL)-17, IL-1β, IL-10, IL-6, IL-8, tumor necrosis factor
      (TNF)-α , osteoprotegerin (OPG), osteocalcin (OC), osteopontin (OPN) , matrix
      metalloproteinase (MMP)-2, MMP-9 , transforming growth factor (TGF)-β , soluble receptor
      activator of nuclear factor ligand (RANKL) and crosslinked telopeptide of type I collagen
      (ICTP) in the PICF were determined using the MAGpix™ instrument and Xponent® software . The
      mean concentration of each mediator was calculated using the individual as a statistical unit
      and expressed as pg/ml.

      All analyses were completed using SAS program release 9.1 . Data were examined for normality
      using the Kolmogorov-Smirnov test, and those that achieved normality were analysed using
      parametric methods. FMPS and FMBS measured before the beginning of each period of
      experimental mucositis in both groups were compared using the Wilcoxon test. For the other
      clinical parameters (PI, BoP, PPM, RCAL and PD), ANOVA two way/Tukey test was used to detect
      differences between groups and periods. Levels of osteo-immunoinflammatory markers between
      groups and among follow-ups were compared using the Wilcoxon and Friedman test, respectively.
      An experimental level of significance was determined at 5%.
    

Intervention name(s): Placebo toothpaste; triclosan/copolymer/fluoride toothpaste
Intervention type(s): Other; Other
Intervention description(s): During an experimental 3-week period of undisturbed mechanical plaque accumulation in the implants, implants randomly assigned to Placebo group will be submitted to a chemical plaque control (three times per day) using a placebo toothpaste.; During an experimental 3-week period of undisturbed mechanical plaque accumulation in the implants, implants randomly assigned to triclosan/copolymer/fluoride group will be submitted to a chemical plaque control (three times per day) using a triclosan/copolymer/fluoride toothpaste.
Intervention MeSH terms: Triclosan; Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This investigation was designed as double-blind, randomized, crossover study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment