Chronic Periodontitis Clinical Trial
Official title:
Evaluation of Antimicrobial Photodynamic Therapy in Multiples Episodes as an Adjunct to Non-surgical Periodontal Treatment in Smokers
The study proposes to assess the effect of multiple applications of antimicrobial Photodynamic Therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in smokers without use of antibiotics. Twenty smokers with a clinical diagnosis of chronic periodontitis will be treated in a split-mouth design study to either aPDT associated with scaling and root planing (SRP) or SRP only. aPDT will be performed by using a laser light source with 690 nm wavelength associated with a phenothiazine photosensitizer. The applications will occur in four episodes (at days 0, 2, 7 and 14). All patients will be monitored for 90 days. Plaque index, probing depth, clinical attachment level and bleeding on probing will be performed at baseline (pre-intervention period) and 30 and 90 days after the (nsPT). Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the nsPT) and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard hybridization. Gingival crevicular fluid samples will be collected (at Day 0, 14, 30 and 90 after the nsPT) and the levels of Interleukin 1 beta, Interleukin 10 and Tumor Necrosis Factor alpha (Luminex) will be evaluated. Salivary cotinine levels will also be evaluated at baseline. Data obtained will be statistically analyzed.
MATERIALS AND METHODS
Consent to search - All patients will receive detailed information about experiment (goals,
benefits, risks and discomforts) in accordance with a consent form in this research. All
procedures will be subject to approval of the Ethics Committee (CEP) of Ribeirão Preto Dental
School (FORP), University of São Paulo (USP).
Sample Size Calculation - The sample size was determined to provide 80% power to recognize a
significant difference of 1 mm (d) between groups with a 95% confidence interval (a = 0.05)
and standard deviation (s) of 1.0 mm. Considering the changes in mean clinical attachment
level (CAL) as the primary outcome variable and [Za (1.96) + Zb (0.84)]2 = 7.84. Size
calculation was based on the following formula: n = {2[(s)2/(d)2]} · (Za + Zb)2. Therefore, a
total of 16 patients were required. However, the number of patients enrolled in this study
was 20, considering that some patients could be lost during follow-up.
Experimental Design -The selected subjects will receive specific oral hygiene instruction and
supragingival scaling in all teeth, seven days before the start of interventions. The study
type will be split mouth with two pairs of contralateral uni-root teeth with proximal
periodontal sites presenting probing depth ≥ 5 mm for the clinical, microbiological and
immunological assessment. A random number table will be generated by a computer program, each
of the selected pairs dental receive the following treatments: SRP or SRP + several aPDT
episodes. The clinical, immunological and microbiological parameters will be evaluated at
baseline (pre-intervention) and after the completion of non-surgical periodontal therapy. The
periodontal clinical examinations (pre and post-intervention) will be performed by a single
trained and calibrated examiner, who unknown the experimental groups of this study. Examiners
are also blind to study the immunological and microbiological analyzes. SRP procedures and
use of the aPDT protocol should be performed by other trained operator for these purposes.
An impression with alginate will be performed in each patient to obtain the models of the
dental arches and development of a guide plate on acetate with reference grooves to
standardize the insertion and inclination of computerized periodontal probe (Florida Probe
System, Florida Probe Corporation , Gainesville, FL, USA). The visible plaque index of each
patient, will be assessed dichotomously (O'Leary et al., 1972) and determined by the
percentage of tooth surfaces with plaque. In 6 sites of each tooth (mesio-buccal, buccal,
distobuccal, mesio- lingual, lingual and disto-lingual) will be assessed clinical periodontal
parameters: Probing Depth (mm) that will be measured from the gingival margin to the pocket
bottom; relative Clinical Attachment Level (mm) that will be measured from the occlusal plate
guide to the pocket bottom; Bleeding on probing, rated dichotomously (Ainamo, Bay, 1976), the
presence of bleeding is considered positive when presented within 20s after the probe
insertion for measuring probing depth. These clinical parameters and each patient's plaque
index will be recorded at baseline (pre-intervention period) as well as +30 and +90 days
after the non-surgical periodontal therapy.
Examiner Calibration - The Kappa index will be used to evaluate the examiner calibration for
collection of clinical periodontal parameters in order to measure the intra-examiner
agreement. According to the World Health Organization (WHO) for diagnostic criteria,
acceptable index Kappa agreement must be greater or equal to 0.85 (WHO, 1997). This agreement
level will be used for calibration of the examiner in this project. Ten patients will be
selected, at least two pairs of contralateral teeth uni-roots with probe depth ≥5 mm in the
proximal sites. Each patient is scanned twice using computerized periodontal probe (Probe
Corporation Florida, Gainesville, FL, USA) with a 48-hour interval between the first and
second examination in order to obtain the intra-examiner reliability, which will be measured
by determining the Kappa index.
Immunologic Analysis - At baseline and on days +14, +30 and +90, after non-surgical
periodontal therapy will be collected GCF samples from selected teeth. The supragingival
plaque these elements will be removed and the sites will be gently dried with air jets and
subsequently isolated using sterile cotton rolls. The GCF samples are obtained from the
mesial and distal sites to the use of Periopaper strips (Oralflow Inc., Amityville, NY, USA).
The strips will be carefully placed on the margin of the gingival sulcus for 30 seconds. The
amount of absorbed gingival fluid will be determined by an electronic meter of wet mass
Periotron (Oralflow Inc., Amityville, NY). The strips are placed in sterile eppendorf vials
of the type which will be stored at a temperature of 80C for later quantification of
cytokines (pg/ml) TNF-α, IL-1β and IL-10. Cytokine levels are determined using a 3-plex kit
Millipore (Millipore Corporation, Billerica, MA, USA) 100TM and the Luminex system (Luminex,
MiraiBio, Alameda, CA, USA).
Salivary Cotinine analysis - Cotinine is a metabolite of nicotine which allows monitoring
patient exposure to nicotine (McGuire et al., 1989). Cotinine levels will be identified at
baseline by immunoenzymatic analysis (ELISA) (Salimetrics Inc., State College, PA, USA) using
a kit for the quantitative analysis of cotinine in saliva according to the manufacturer's
instructions.
Microbiological Analysis - At baseline and on days +30 and +90, after performing non-surgical
periodontal therapy, subgingival plaque samples of the selected teeth will be collected at
the proximal periodontal pockets (mesial and distal). Counts of 40 subgingival species will
be determined in each sample using the method checkerboard DNA-DNA hybridization (Birth et
al., 2008). For the collection of subgingival plaque, the sites will be isolated with sterile
cotton rollers and dry with air jets. The supragingival plaque will be removed carefully
using a sterile curette. Subsequently, another sterile curette is used to collect subgingival
plaque, starting from the deepest portion of the pocket to the coronal region. The samples
will be transported in sterile Eppendorf vials and processing in Dental Molecular Diagnostics
Laboratory of the School of Dentistry of Ribeirão Preto-USP
Non-surgical Periodontal Therapy - At 7 day prior to the non-surgical periodontal therapy all
patients will pefrom a complete periapical radiographic examination of the entire mouth. They
will be grouped into an oral hygiene program (OHP) according to the specific needs. In this
program patients will receive instructions for effective self-plaque, including information
about Bass technique (Bass, 1954) and interproximal cleaning with dental floss and
interdental brushes. They will also be encouraged to brush the tongue once a day and receive
a single dentifrice to be used during the whole experimental period (Colgate Total, Anakol
Ind. Com. Ltda - Kolynos do Brasil - Colgate Palmolive Co., São Bernardo do Campo, SP,
Brasil). After the completion of this oral hygiene program, patients will be submitted to
evaluation of clinical periodontal parameters previously described, and also will be
collected subgingival plaque and GCF samples on selected sites (baseline - pre-intervention
period). Soon after, will receiving supragingival scaling and polishing with a coronary
rubber cups in all teeth in the oral cavity.
Non-surgical periodontal therapy is initiated 7 days after the execution of the OHP and
initial supragingival scaling. The treatment will be made by one skilled in Periodontology,
at an interval of 24 hours by scaling (supragingival and subgingival) and root planing of all
teeth with periodontal disease, using hand (Curetas Gracey, Hu-Friedy, Chicago, IL, EUA) and
ultrasonic tools. The instrumentation will be held quadrant by quadrant, until adequate
cleaning of the area and root planing, which will be checked with the help of an explorer.
Individuals will receive professional cleaning biweekly up to three months after the end of
nonsurgical periodontal therapy. In Fortnightly control and evaluation, patient cooperation
towards the study will be monitored, verifying the state of oral hygiene.
Statistical Analysis - Normality and homoscedasticity of the data will be checked. The inter-
and intra-group comparisons in different time intervals will be achieved through adequate
parametric or non-parametric tests. For all statistical analysis will use a 5% significance
level. All calculations are performed using SPSS software (SPSS, Chicago IL, EUA).
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