Periodontal Debridement Associated With Systemic Antibiotics and Single/Repeated PDT to Treat Aggressive Periodontitis
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
1 other identifier
interventional
46
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 23, 2017
CompletedFirst Posted
Study publicly available on registry
April 28, 2017
CompletedApril 28, 2017
April 1, 2017
1.6 years
April 23, 2017
April 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Probing Depth (PD)
Evaluate the difference between baseline and 6 months PD measures.
0, 3 and 6 post-operatively
Study Arms (6)
PD + (AMX + MET)
ACTIVE COMPARATORperiodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg
PD + CLM
ACTIVE COMPARATORperiodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic clarithromycin 500 mg
PD + (AMX + MET) + sPDT
ACTIVE COMPARATORperiodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg and single application of PDT
PD + CLM + sPDT
ACTIVE COMPARATORperiodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Clarithromycin 500 mg and single application of PDT
PD + (AMX + MET) + rPDT
ACTIVE COMPARATORperiodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Amoxicillin 500 mg + Metronidazole 400 mg and repeated application of PDT
PD + CLM + rPDT
ACTIVE COMPARATORperiodontal pockets that will receive full-mouth ultrasonic debridement associated with systemic Clarithromycin 500 mg and repeated application of PDT
Interventions
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Administration of Amoxicillin 500mg tid for 7 days
Administration of Metronidazole 400mg tid for 7 days.
Administration of Clarithromycin 500mg bid for 7 days
Single application of photodynamic therapy (PDT) at day 0.
Repeated application of photodynamic therapy (PDT) at 0, 1, 2, 7 and 14 days post-operatively.
Eligibility Criteria
You may qualify if:
- 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);
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
College of Dentistry - São José dos Campos, São Paulo State University
São José dos Campos, São Paulo, 12245-000, Brazil
Related Publications (1)
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.
PMID: 19563331BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mauro P Santamaria, DDS, PhD
Universidade Estadual Paulista Júlio de Mesquita Filho
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Adjunct professor
Study Record Dates
First Submitted
April 23, 2017
First Posted
April 28, 2017
Study Start
March 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
April 28, 2017
Record last verified: 2017-04