Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03132714 |
| Other study ID # |
rPDT&antibioticsCFA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
April 23, 2017 |
| Last updated |
April 26, 2017 |
| Start date |
March 2015 |
| Est. completion date |
October 2016 |
Study information
| Verified date |
April 2017 |
| Source |
Universidade Estadual Paulista Júlio de Mesquita Filho |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this project is to compare the efficacy and the local effect of the association
of single or repeated application of photodynamic therapy (PDT) with antibiotic agents using
Amoxicillin + Metronidazole or Clarithromycin in the treatment of patients with Generalized
Aggressive Periodontitis (GAgP).
Description:
The study methodology is according to CONSORT-STATEMENT 2010 and SPIRIT 2013 for randomized
controlled clinical trials.
Study Design
The study is designed as a prospective, interventional, parallel, blinded, randomized,
controlled clinical trial aimed to compare the efficacy and the local effect of the
association of single or repeated application of photodynamic therapy (PDT) with antibiotic
agents using Amoxicillin + Metronidazole or Clarithromycin in the treatment of patients with
Generalized Aggressive Periodontitis (GAgP).
Source of data
The population of this study will be recruited among patients referred to the Science and
Technology Institute (ICT) - São José dos Campos, College of Dentistry. Each one of 46
patients will have three pockets with probing depth and loss of clinical attachment level ≥5
mm and bleeding on probing not located at furcation sites randomly chosen.
Power calculation
A population of 46 patients (138 periodontal pockets, 3 per patient) that meet the
pre-established criteria will be considered. Considering α = 5% and a β = 5% to detect a
difference of 1 mm between groups in probing depth reduction of pockets ≥5 mm, for a
standard deviation of 0.8 mm, 14 patients will be needed in each group. With a sample of 46
patients (138 pockets), the study will have a power greater than 95%.
Clinical Parameters
All clinical parameters will be assessed by a single blinded, trained and calibrated
examiner (CFA) before periodontal therapy (baseline) and at 3 and 6 months after using a
manual probe. Measurements will be done at six sites per tooth (mesiobuccal, buccal,
disto-buccal, distolingual, lingual, and mesiolingual) in all teeth, except third molars.
The following clinical parameters will be evaluated: 1) Full-mouth plaque index (FMPI); 2)
Bleeding on probing (BoP); 3) Probing depth (PD): distance from the bottom of sulcus/pocket
to gingival margin; 4) Gingival recession (GM): distance from the free gingival margin to
cement-enamel junction (CEJ); 5) Clinical attachment level (CAL): distance from bottom of
sulcus/pocket to the CEJ. The CEJ will be identified by careful probe on cervical area.
Calibration and Randomization
Initially, a total of ten patients presenting with GAgP will be selected. The designated
examiner (CFA) will measure CAL and PD in all patients twice within 24 hours, with an
interval of ≥ 1 hour between examinations. Then, the measures will be submitted to
intraclass correlation test and the examiner will be judged calibrated if reaches 90%
agreement.
Patients will be allocated into two antibiotic groups (that will receive Amoxicillin +
Metronidazole or Clarithromycin) according to a computer-generated list. The allocation will
be implemented by an investigator (NCCS) who was not directly involved in the examination or
treatment procedures. All medication will be prepared and encased in identical opaque coded
bottles by a compounding pharmacy. The same person outside the project will generate a
random sequence regarding the type of PDT application for each patient, for the three
previously selected pockets (single or repeated application of PDT or control), which will
be revealed shortly after the periodontal debridement session.
Treatment Protocols
All patients will be treated with periodontal therapy through of the one-stage, full mouth,
ultrasonic debridement (FMUD). In a single session, patients will receive local anesthesia
and periodontal debridement with ultrasound equipment (Cavitron - Dentsply EUA) and
subgingival tips (UI25KSF10S, Hu-Friedy). All diseased sites will be instrumented in this
one session. The debridement session will be performed by a single experienced and trained
periodontist (NA), different from the examiner (ca). Immediately before the mechanical
therapy, patients will be allocated in one of the two treatment protocols: Clarithromycin
(CLM) group (n = 22): FMUD + CLM 500 mg bid, for 7 days or Amoxicillin (AMX) + metronidazole
(MET) group (n = 22): FMUD + (AMX 500 mg tid + MET 400 mg tid, both for 7 days. All patients
will start taking the pills immediately before the FMUD session.
After periodontal debridement (PD), two periodontal pockets from each patient will receive
the proposed PDT protocols to assist the decontamination of diseased sites. One pocket will
receive a single application of PDT (sPDT) (baseline only) and the other will receive
repeated application of PDT (rPDT). After subgingival irrigation with saline solution to
wash the pocket, the photosensitizer (methylene blue 10 mg / mL) will be applied to the
bottom of the pocket by buccal side until it is completely filled. After one minute, the
pocket will be washed with water and exposed to low-level laser (TheraLase - Brazil), with a
corresponding optical fiber of 600 um diameter, which will be inserted into the pocket. A
660 nm wavelength with a power of 60 milliwatts and a dose of 129 J / cm2 will be used for
one minute. The same procedure will be repeated by lingual site, totaling two minutes of
application per pocket. The repeated application protocol will consist of 5 applications on
different days, performed on the day of periodontal treatment (baseline - 0), 1, 2, 7 and 14
days after. Thus, the following comparative groups will be formed, totaling 138 pockets:
PD + (AMX + MET) (n = 23): periodontal pockets that will receive periodontal debridement
associated with Amoxicillin + Metronidazole;
PD + CLM (n = 23): periodontal pockets that will receive periodontal debridement associated
with the use of Clarithromycin;
PD + (AMX + MET) + sPDT (n = 23): periodontal pockets that will receive periodontal
debridement associated with Amoxicillin + Metronidazole and single application of PDT; PD +
CLM + sPDT (n = 23): periodontal pockets that will receive periodontal debridement
associated with the use of Clarithromycin and single application of PDT;
PD + (AMX + MET) + rPDT (n = 23) : periodontal pockets that will receive periodontal
debridement associated with Amoxicillin + Metronidazole and repeated application of PDT;
PD + CLM + rPDT (n = 23): periodontal pockets that will receive periodontal debridement
associated with Clarithromycin and repeated application of PDT
Statistical analysis
Mean and standard deviation will be calculated for each parameter. The normal distribution
of the data will be analyzed by Shapiro-Wilk test. Data from clinical measurements will be
subjected to analysis of variance (repeated measures) for inter and intra-group comparison.
