Periodontal Debridement Associated With Systemic Antibiotics and Single/Repeated PDT to Treat Aggressive Periodontitis
Launched by UNIVERSIDADE ESTADUAL PAULISTA JÚLIO DE MESQUITA FILHO · Apr 26, 2017
Trial Information
Current as of April 27, 2025
Completed
Keywords
ClinConnect Summary
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 recruit...
Gender
ALL
Eligibility 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.
About Universidade Estadual Paulista Júlio De Mesquita Filho
Universidade Estadual Paulista Júlio de Mesquita Filho (UNESP) is a prominent public research university in Brazil, recognized for its commitment to advancing scientific knowledge and innovation in various fields, including health sciences. As a clinical trial sponsor, UNESP leverages its extensive academic resources and interdisciplinary expertise to conduct rigorous clinical research aimed at improving patient outcomes and advancing medical practices. The university fosters collaboration among researchers, healthcare professionals, and industry partners, ensuring adherence to ethical standards and regulatory compliance throughout the research process. UNESP's dedication to excellence in clinical trials contributes significantly to the global body of medical knowledge and public health advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sao Jose Dos Campos, Sp, Brazil
Patients applied
Trial Officials
Mauro P Santamaria, DDS, PhD
Principal Investigator
Universidade Estadual Paulista Júlio de Mesquita Filho
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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