Periodontal Debridement Associated With Systemic Antibiotics and Single/Repeated PDT to Treat Aggressive Periodontitis
NCT ID: NCT03132714
Last Updated: 2017-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
46 participants
INTERVENTIONAL
2015-03-31
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PD + (AMX + MET)
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg
Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Amoxicillin 500mg
Administration of Amoxicillin 500mg tid for 7 days
Metronidazole 400mg
Administration of Metronidazole 400mg tid for 7 days.
PD + CLM
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic clarithromycin 500 mg
Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Clarithromycin 500mg
Administration of Clarithromycin 500mg bid for 7 days
PD + (AMX + MET) + sPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg and single application of PDT
Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Amoxicillin 500mg
Administration of Amoxicillin 500mg tid for 7 days
Metronidazole 400mg
Administration of Metronidazole 400mg tid for 7 days.
Single application of PDT
Single application of photodynamic therapy (PDT) at day 0.
PD + CLM + sPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Clarithromycin 500 mg and single application of PDT
Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Clarithromycin 500mg
Administration of Clarithromycin 500mg bid for 7 days
Single application of PDT
Single application of photodynamic therapy (PDT) at day 0.
PD + (AMX + MET) + rPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg and repeated application of PDT
Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Amoxicillin 500mg
Administration of Amoxicillin 500mg tid for 7 days
Metronidazole 400mg
Administration of Metronidazole 400mg tid for 7 days.
Repeated application of PDT
Repeated application of photodynamic therapy (PDT) at 0, 1, 2, 7 and 14 days post-operatively.
PD + CLM + rPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Clarithromycin 500 mg and repeated application of PDT
Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Clarithromycin 500mg
Administration of Clarithromycin 500mg bid for 7 days
Repeated application of PDT
Repeated application of photodynamic therapy (PDT) at 0, 1, 2, 7 and 14 days post-operatively.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Amoxicillin 500mg
Administration of Amoxicillin 500mg tid for 7 days
Metronidazole 400mg
Administration of Metronidazole 400mg tid for 7 days.
Clarithromycin 500mg
Administration of Clarithromycin 500mg bid for 7 days
Single application of PDT
Single application of photodynamic therapy (PDT) at day 0.
Repeated application of PDT
Repeated application of photodynamic therapy (PDT) at 0, 1, 2, 7 and 14 days post-operatively.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* presence of ≥20 teeth, excluding third molars and teeth indicated for extraction;
* presence of ≥6 sites presenting PD ≥5 mm with bleeding on probing and ≥2 sites with PD ≥7 mm (including incisors and first molars, in addition to two other non-contiguous teeth between them);
* presence of three non-adjacent periodontal pockets with probing depth ≥5 mm and bleeding on probing not located in furcation area;
* good general health (ASA I/II);
* 18-35 years old;
* agree to participate in the study and sign a written consent (Resolution # 196 of October 1996 and the Brazilian Professional Code of Dental Ethics - 179/93).
Exclusion Criteria
* suffer from any systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc - ASA III/IV/V);
* antimicrobials or anti-inflammatory drugs in the previous 6 months;
* periodontal treatment within the last 12 months;
* smoke ≥10 cigarettes/day;
* reported allergy to amoxicillin, metronidazole or clarithromycin;
* required antibiotic prophylaxis;
* current use of any medication that could interfere with periodontal response were excluded from the study.
18 Years
35 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidade Estadual Paulista Júlio de Mesquita Filho
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mauro Pedrine Santamaria
PhD Adjunct professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mauro P Santamaria, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade Estadual Paulista Júlio de Mesquita Filho
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
College of Dentistry - São José dos Campos, São Paulo State University
São José dos Campos, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lulic M, Leiggener Gorog I, Salvi GE, Ramseier CA, Mattheos N, Lang NP. One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial. J Clin Periodontol. 2009 Aug;36(8):661-6. doi: 10.1111/j.1600-051X.2009.01432.x. Epub 2009 Jun 25.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
rPDT&antibioticsCFA
Identifier Type: -
Identifier Source: org_study_id