Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03145610 |
| Other study ID # |
Triclosan Mucositis |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
April 27, 2017 |
| Last updated |
May 8, 2017 |
| Start date |
June 1, 2013 |
| Est. completion date |
January 14, 2015 |
Study information
| Verified date |
May 2017 |
| Source |
Paulista University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study was to evaluate the influence of a triclosan-containing toothpaste in
the profile of osteo-immunoinflammatory mediators in the peri-implant crevicular fluid
(PICF) and in the clinical parameters during the progression of experimental peri-implant
mucositis.
Description:
Study design This investigation 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 and in the clinical parameters during the
progression of experimental peri-implant mucositis. This study was approved by the ethics
committee of Paulista University (Protocol 97.117).
Population screening Patient recruitment started in June 2013 and was completed by the end
of May 2014. The clinical procedures and evaluations were carried out between August 2013
and June 2014. Data entry and statistical analyses were performed in January 2015. All the
patients in the study were recruited from the patients referred to Paulista University.
All eligible individuals were thoroughly informed of the nature, potential risks and
benefits of their participation in the study, and they each signed an informed consent
document.
Experimental groups During an experimental 3-week period of undisturbed plaque accumulation
in the implants, patients were randomly assigned to two groups, according to chemical plaque
control (three times per day): Triclosan (n=11): triclosan/copolymer/fluoride toothpaste or
Placebo (n=11): fluoride toothpaste. Undisturbed plaque accumulation was achieved only in
the nearby of dental implants by using an individual silicone tray involving the implant and
adjacent teeth covering 2-3mm of peri-implant mucosa. The same silicone tray was filled by
the respective toothpaste, according to the experimental group, during this period.
Following 3 weeks, a professional prophylaxis was performed and a wash-out period of 30 days
was established. Then, a second experimental 3-week period of undisturbed plaque
accumulation in the implants was established and the experimental groups were exchanged.
After that, a new professional prophylaxis was performed. All evaluations (clinical and
immunoenzimatic assays) were performed at baseline, 3, 7, 14 and 21 days of each period of
experimental mucositis induction.
The number of patients included in the present study was based on previous crossover
investigations that found differences in the clinical parameters and crevicular fluid levels
of osteo-immunoinflammatory markers in different clinical status.
Clinical examination The same examiner, who was blinded to the groups, performed all
measurements of clinical assessment. To perform the intra-examiner calibration, 15 non-study
individuals presenting dental implants were selected. The examiner measured the PD of all
patients twice within 24 hours. The examiner was judged to be reproducible after fulfilling
the pre-determined success criteria (the percentage of agreement within ± 1 mm between
repeated measurements had to be at least 90%). The intra-class correlation was calculated as
92% reproducibility.
An individual stent was prepared to standardize the location of periodontal probe (North
Carolina - Hu-Friedy, Chicago, IL, USA) 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/%): scored using a dichotomous plaque index along the mucosal margin around
implants, 2) bleeding index (BI/%): scored using dichotomous index of mucosal marginal
bleeding around implants, 3) Position of the peri-implant margin (PPM/mm), which was the
distance from the stent to the peri-implant margin; 4) Relative clinical attachment level
(RCAL/mm), which was the 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. The full
mouth plaque scores (FMPS) and bleeding scores (FMBS) were calculated before the beginning
of each period of experimental mucositis induction.
Osteo-immunoinflammatory profile assessment Peri-implant crevicular fluid was collected from
dental implant sites by the same examiner. The area was isolated, dried and fluid was
collected at two sites of the experimental dental implants (vestibular and lingual) by
placing filter paper strips (Periopaper, Oraflow, Plainview, NY, USA) into the sulcus until
the clinician perceived a slight resistance, and then leaving in place for 15 s. The fluid
volume was measured with a calibrated device (Periotron 8000, Oraflow, Plainview, NY, USA).
The strips were placed into sterile tubes containing 400 μL of phosphate-buffered saline
(PBS) with 0.05% Tween-20. Peri-implant crevicular fluid samples were immediately stored at
-20 °C.
Levels of interferon (INF), interleukin (IL)-4, IL-17, IL-1β, IL-10, IL-6, IL-23, tumor
necrosis factor (TNF)-α (Human Th17 HTH17MAG-14K, Millipore Corporation, Billerica, MA,
USA), osteoprotegerin (OPG), osteocalcin (OC), osteopontin (OPN) (Human Bone HBNMAG-51K,
Millipore Corporation, Billerica, MA, USA), matrix metalloproteinase (MMP)-2, MMP-9 (Human
MMP Panel 2 HMMP2MAG-55K, Millipore Corporation, Billerica, MA, USA), transforming growth
factor (TGF)-β (Multi-species TGFβ TGFBMAG-64K, Millipore Corporation, Billerica, MA, USA)
and crosslinked telopeptide of type I collagen (ICTP) (Uscn Life Science Inc. Wuhan, Hubei,
PRC) in the peri-implant fluid were determined using commercially available kits. Assays
were carried out according to the manufacturer's recommendations using the MAGpix™
instrument (MiraiBio, Alameda, CA, USA). The samples were individually analyzed, and
concentrations were estimated from the standard curve using a five-parameter polynomial
equation using Xponent® software (Millipore, Corporation, Billerica, MA, USA). The mean
concentration of each mediator was calculated using the individual as a statistical unit and
expressed as pg/ml.
Data analysis All analyses were performed using SAS program release 9.1 (Cary, NC, USA).
Data were firstly examined for normality using the Kolmogorov-Smirnov test, and the data
that achieved normality were analysed using parametric methods. The percentages of
experimental sites with visible plaque accumulation, BI and the PD means were computed for
each implant selected for peri-implant fluid sampling. Subsequently, clinical parameters and
the local levels of osteo-immunoinflammatory mediators were averaged into Placebo and
Triclosan groups. The differences in FMPS and FMBS - measured before the beginning of each
period of experimental mucositis induction.- between both groups were compared using the
Wilcoxon test. For the other clinical parameters (PI, BI, PPM, RCAL and PD), ANOVA/Tukey
test was used to detect differences between groups and periods. Concentrations 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% for all statistical analyses.
