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Periodontal Debridement Associated With Systemic Antibiotics and Single/Repeated PDT to Treat Aggressive Periodontitis

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ClinicalTrials.gov Identifier: NCT03132714
Recruitment Status : Completed
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief 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).

Condition or disease Intervention/treatment Phase
Aggressive Periodontitis, Generalized Procedure: Full-mouth ultrasonic debridement Drug: Amoxicillin 500mg Drug: Metronidazole 400mg Drug: Clarithromycin 500mg Procedure: Single application of PDT Procedure: Repeated application of PDT Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Local Effect of Periodontal Debridement Associated With Different Systemic Antibiotic Protocols and Single or Repeated Application of Photodynamic Therapy to Treat Generalized Aggressive Periodontitis: Randomized Controlled Clinical Trial
Study Start Date : March 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: PD + (AMX + MET)
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg
Procedure: Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Other Name: Periodontal debridement

Drug: Amoxicillin 500mg
Administration of Amoxicillin 500mg tid for 7 days
Other Name: Amoxil

Drug: Metronidazole 400mg
Administration of Metronidazole 400mg tid for 7 days.
Other Name: Flagyl

Active Comparator: PD + CLM
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic clarithromycin 500 mg
Procedure: Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Other Name: Periodontal debridement

Drug: Clarithromycin 500mg
Administration of Clarithromycin 500mg bid for 7 days
Other Name: Biaxin

Active Comparator: 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
Procedure: Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Other Name: Periodontal debridement

Drug: Amoxicillin 500mg
Administration of Amoxicillin 500mg tid for 7 days
Other Name: Amoxil

Drug: Metronidazole 400mg
Administration of Metronidazole 400mg tid for 7 days.
Other Name: Flagyl

Procedure: Single application of PDT
Single application of photodynamic therapy (PDT) at day 0.

Active Comparator: PD + CLM + sPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Clarithromycin 500 mg and single application of PDT
Procedure: Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Other Name: Periodontal debridement

Drug: Clarithromycin 500mg
Administration of Clarithromycin 500mg bid for 7 days
Other Name: Biaxin

Procedure: Single application of PDT
Single application of photodynamic therapy (PDT) at day 0.

Active Comparator: 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
Procedure: Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Other Name: Periodontal debridement

Drug: Amoxicillin 500mg
Administration of Amoxicillin 500mg tid for 7 days
Other Name: Amoxil

Drug: Metronidazole 400mg
Administration of Metronidazole 400mg tid for 7 days.
Other Name: Flagyl

Procedure: Repeated application of PDT
Repeated application of photodynamic therapy (PDT) at 0, 1, 2, 7 and 14 days post-operatively.

Active Comparator: PD + CLM + rPDT
periodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Clarithromycin 500 mg and repeated application of PDT
Procedure: Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Other Name: Periodontal debridement

Drug: Clarithromycin 500mg
Administration of Clarithromycin 500mg bid for 7 days
Other Name: Biaxin

Procedure: Repeated application of PDT
Repeated application of photodynamic therapy (PDT) at 0, 1, 2, 7 and 14 days post-operatively.




Primary Outcome Measures :
  1. Change in Probing Depth (PD) [ Time Frame: 0, 3 and 6 post-operatively ]
    Evaluate the difference between baseline and 6 months PD measures.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosis of GAgP (Armitage, 1999; American Academy of Periodontology, 2015);
  • 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:

  • pregnant or nursing;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132714


Locations
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Brazil
College of Dentistry - São José dos Campos, São Paulo State University
Sao Jose dos Campos, SP, Brazil, 12245-000
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Principal Investigator: Mauro P Santamaria, DDS, PhD Universidade Estadual Paulista Júlio de Mesquita Filho

Publications:
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Responsible Party: Mauro Pedrine Santamaria, PhD Adjunct professor, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03132714     History of Changes
Other Study ID Numbers: rPDT&antibioticsCFA
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho:
Full-mouth ultrasonic debridement
Clarithromycin
Amoxicillin
Metronidazole
Antimicrobial therapy
Photodynamic therapy
Low-level laser therapy

Additional relevant MeSH terms:
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Periodontitis
Aggression
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms
Anti-Bacterial Agents
Amoxicillin
Metronidazole
Clarithromycin
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors