Aggressive Periodontitis Clinical Trial
Official title:
Clinical, Microbiological and Immunological Effects of Antimicrobial Photodynamic Therapy on Non-surgical Treatment of Aggressive Periodontitis: a Double-blind Split-mouth Randomized Controlled Clinical Trial.
The treatment of aggressive periodontitis (AgP) represents a challenge for clinicians, because there are no standardized protocols for efficient control of the disease. The aim of this study is to evaluate the effect of multiple applications of antimicrobial photodynamic therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in patients diagnosed with AgP. Twenty patients with a clinical diagnosis of AgP will be treated in a split-mouth design study to either aPDT associated with scaling and root planning (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 (days 0, 2, 7 and 14). All patients will be monitored for 90 days. Clinical assessment of 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 baseline and 14, 30 and 90 after the nsTP) for evaluation the volume of fluid (Periotron) and the levels of Interleukin 1 beta, Interleukin 10 and Tumor Necrosis Factor alpha (Luminex). Data obtained will be statistically analyzed.
Non-Surgical Periodontal Therapy
Seven days prior to the non-surgical periodontal therapy, periapical radiographs will be
taken from the whole mouth of all patients. They will be set in an oral hygiene program
(OHP) according to their specific needs. In this program, patients will be instructed about
an effective self-performed plaque control, including information about the Bass Technique
(Bass, 1954) and interproximal cleaning with dental floss and interdental brushes. They will
be also motivated to brush the dorsal surface of the tongue once a day and will receive a
dentifrice that shall be used throughout the experimental period (Colgate Total®, Anakol
Ind. Com Ltda - Brazil's Kolynos - Colgate Palmolive Co., Sao Bernardo do Campo, SP,
Brazil). After the OHP, subjects will undergo the assessment of clinical periodontal
parameters previously described and the collection of subgingival plaque and GCF in selected
sites (baseline) will be performed. Shortly, patients will receive supragingival scaling and
coronal polishing with prophy cup on all the teeth present in the oral cavity. The
non-surgical periodontal therapy will initiate 7 days after the OHP and initial
supragingival scaling. Within 24 hours, a specialist in Periodontics will perform supra and
subgingival scaling and root planing of all teeth with periodontal involvement, using hand
(Gracey Curettes, Hu-Friedy, Chicago, IL, USA) and ultrasonic instruments. The
instrumentation will be performed on each quadrant until achievement of an adequate cleaning
and root planing, which will be verified with a dental explorer. Individuals will receive
professional prophylaxis biweekly during three months after the end of the nonsurgical
periodontal therapy. On biweekly follow-up visits, patient's cooperation will be monitored
by verifying the status of oral hygiene.
Antimicrobial photodynamic Therapy
After a full-mouth scaling and root planning (SRP), the periodontal pockets of teeth
selected to receive antimicrobial photodynamic therapy (aPDT) will be irrigated with
distilled water. Shortly thereafter, the dye will be applied (phenothiazine hydrochloride-
10mg/mL) from the bottom of the pocket. After 1 minute, irrigation will be performed with
distilled water to remove the excess of dye. The stained area will be irradiated with a
diode laser (660 nm and a 60 mW/cm²). Six sites per tooth under treatment will be irradiated
(10 seconds/ site). The applications of aPDT will be repeated in the same way until the
second week (days: 2, 7,14). Before the application, the supragingival plaque will be
removed.
Each patient will be impressed with alginate in order to obtain models of the dental arches
and elaborate a guide plate made of acetate. This plate will present grooves that will be
used as references to standardize the insertion and tilt of the automated periodontal probe
(Florida Probe System, Florida Probe Corporation, Gainesville, FL, USA). The visible plaque
index for each patient, rated dichotomously (O'Leary et al. 1972), will be determined by the
percentage of tooth surfaces with deposits of plaque stained with disclosing solution.
Clinical monitoring
The following clinical periodontal parameters will be assessed at 6 sites of each tooth
(mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual): (i) probing
pocket depth (PPD): it will be measured from the gingival margin to the bottom of the
pocket; (ii) gingival recession (GR): it will be measured from the enamelcement junction to
the bottom of the pocket; (iii) clinical attachment level (CAL): it will be measured as PPD
+ GR (GR will be equal to 0 whenever the cementenamel junction is covered); (iv) bleeding on
probing (BOP): it will be evaluated dichotomously: the presence of the bleeding will be
considered positive when occurring within 30 seconds from the insertion of the probe for
probing depth; (v) Plaque index (PI): it will be evaluated dichotomously. BOP, PPD, CAL and
GR will be measured at six sites per tooth (mesio-buccal, buccal, disto-buccal,
disto-lingual, lingual and mesio-lingual). All probing measurements will be performed using
an automated periodontal probe.
The clinical periodontal parameters and the plaque index of each patient will be recorded at
baseline (pre-intervention), as well as +30 and +90 days after the non-surgical periodontal
therapy. The Kappa index will be used to evaluate the examiner calibration on clinical
periodontal parameters collection in order to calculate the intra-examiner agreement.
According to the World Health Organization (WHO) criteria for diagnosis, the acceptable
Kappa index of agreement must be greater than or equal to 0.85 (WHO, 1997). This level of
agreement will be used for calibration of the examiner in this project. Ten patients, each
one showing at least two pairs of contralateral single-rooted teeth with PD ≥ 5 mm on
interproximal sites, will be selected to calibrate the examiner. Each patient will be
evaluated on two separate occasions 48 hours apart in order to obtain the intra-examiner
reliability through the Kappa index.
Immunological monitoring
At baseline and +14 and +30 and +90 days after the non-surgical periodontal therapy, GCF
samples will be obtained from eight interproximal sites of each patient. The supragingival
plaque from selected teeth will be removed and the sites will be carefully dried with air
jets, and subsequently isolated with sterile cotton rolls. Samples of GCF will be obtained
with papers strips (Periopaper® -Oralflow Inc., Amityville, NY, USA). The papers strips will
be gently inserted into the orifice of the periodontal pocket, remaining 30 seconds
subgingivally. The amount of GCF absorbed will be determined by an electronic measurer of
humid mass (Periotron® -Oralflow Inc., Amityville, NY, USA). Samples will be placed in
sterile Eppendorf tubes stored at - 80°C for cytokines (IL-1β, IL-10 and TNF-a)
quantification (pg/μl) at Genese Laboratory (Genese Produtos Diagnosticos LTDA, Sao Paulo,
SP, Brazil). Cytokines levels will be determined using a three-plex Millipore kit (Millipore
Corporation, Billerica, MA, USA) and the Luminex 100TM system (Luminex, MiraiBio, Alameda,
CA, USA).
Microbiological monitoring
At baseline and +30 and +90 days after the non-surgical periodontal therapy, samples of
subgingival plaque will be obtained from eight interproximal sites of each patient. Samples
will be individually analyzed for their content of 40 subgingival bacterial species using
the checkerboard DNA-DNA hybridization technique (Socransky et al., 2004a; Socransky et al.,
2004b). The selected teeth will be isolated with sterile cotton rolls and dried with air
jets. Then, the supragingival plaque will be carefully removed using a sterile curette.
Another sterile curette will be used to collect the subgingival plaque, starting from the
bottom of the periodontal pocket to its coronal portion. The samples will be stored in
sterilized Eppendorf tubes and will be processed at the Microbiology Laboratory of the
Guarulhos University (UNG, Guarulhos, SP, Brazil).
Statistical analysis
The normality and homoscedasticity of the data obtained will be checked. Comparisons within
groups and among groups at different time intervals will be performed through parametric or
non-parametric appropriate tests. The significance level will be set at 5% in all tests. All
calculations will be performed by SPSS software (SPSS, Chicago IL, USA).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05043935 -
The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Aggressive Periodontitis
|
N/A | |
Terminated |
NCT01993368 -
Analysis of Osteoimmune Interactions Linking Inflammation and Bone Destruction in Aggressive Periodontitis
|
N/A | |
Completed |
NCT02282800 -
Immunolocalization of 1,25,Dihydroxyvitamin D3 in Aggressive Periodontitis Patients
|
N/A | |
Recruiting |
NCT02833285 -
B Cell Functions in Periodontitis
|
||
Completed |
NCT02127203 -
Nitro-oxidative Stress in Periodontitis
|
N/A | |
Completed |
NCT02223702 -
Alternative Antibiotic Regime in the Treatment of GAgP
|
Phase 4 | |
Completed |
NCT03093246 -
Omega-3 Plus Low-dose Aspirin Daily Supplementation in Non-surgical Therapy to Treat Aggressive Periodontitis
|
Phase 2/Phase 3 | |
Completed |
NCT03093207 -
Omega-3 Fatty Acids Plus Low-dose Aspirin Daily Supplementation in Surgical Therapy to Treat Aggressive Periodontitis
|
Phase 2/Phase 3 | |
Completed |
NCT05295576 -
Effect of Non Surgical Periodontal Therapy on Inflammatory Markers in Chronic Periodontitis Patients
|
||
Completed |
NCT05297084 -
Non Surgical Periodontal Treatment Effect on Il-17 and Il-18 in Aggressive Periodontitis
|
||
Completed |
NCT02969928 -
Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis
|
Phase 2/Phase 3 | |
Completed |
NCT02829983 -
Clarithromycin as Adjuvant to Periodontal Debridement
|
N/A | |
Completed |
NCT02927704 -
Gingival Crevicular Fluid Levels Of Monocyte Chemoattractant Protein-1
|
N/A | |
Completed |
NCT02817568 -
Frequency Of MCP-1 And CCR2 Gene Polymorphisms And Its Effect On Gene Expression In Patients With AgP
|
N/A | |
Active, not recruiting |
NCT04051255 -
Influence of Smoking on Clinical, Microbiological and Immunologic Parameters in Patients With Aggressive Periodontitis.
|
N/A | |
Completed |
NCT05001919 -
Concentrated Growth Factors in Treatment of Intrabony Defects in Localized Aggressive Periodontitis
|
Phase 1/Phase 2 | |
Completed |
NCT03727620 -
Doxycycline in the Treatment of Aggressive Periodontitis
|
Phase 1/Phase 2 | |
Completed |
NCT04223869 -
IL-34 Levels in Various Types of Periodontitis
|
N/A | |
Completed |
NCT03034824 -
Effects of Er,Cr:YSGG, Diode Lasers on GCF Cytokines Levels
|
N/A | |
Recruiting |
NCT01510808 -
The Affect of Orthodontic Treatment on the Periodontal Status of Patients With Aggressive Periodontitis
|
N/A |