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Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02969928
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief Summary:
The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic debridement combined with clarithromycin or amoxicillin + metronidazole association for the treatment of generalized aggressive periodontitis (GAgP).

Condition or disease Intervention/treatment Phase
Aggressive Periodontitis Procedure: Full-mouth ultrasonic debridement Drug: Clarithromycin Drug: Amoxicillin Drug: Metronidazole Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Full-mouth Periodontal Debridement Associated With Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis: Randomized Controlled Clinical Trial
Study Start Date : March 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Amoxicillin and Metronidazole
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Procedure: Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Other Name: Periodontal debridement

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

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

Experimental: Clarithromycin
In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Procedure: Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Other Name: Periodontal debridement

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




Primary Outcome Measures :
  1. Change in Clinical Attachment Level (CAL) [ Time Frame: Baseline, 3 and 6 months ]
    Evaluate the difference between baseline and 6 months CAL measures.


Secondary Outcome Measures :
  1. Change in Probing Depth (PB) [ Time Frame: Baseline, 3 and 6 months ]
    Evaluate the difference between baseline and 6 months PB measures.

  2. Change in Bleeding on Probe (BoP) [ Time Frame: Baseline, 3 and 6 months ]
    Evaluate the difference between baseline and 6 months BoP measures.


Other Outcome Measures:
  1. Compliance [ Time Frame: One week post treatment ]
    After 7 days of periodontal treatment, patients will be asked to return any medication not taken and/or the empty bottles. The number of pills not taken by the subject will be documented in order to evaluate compliance.

  2. Adverse Effects That May be Related to Antibiotic Treatment [ Time Frame: One week post treatment ]
    Patients will be instructed to fill a self-report form about any possible adverse effects in order to help evaluate their adherence to the systemic antimicrobial regimen.



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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:

  1. diagnosis of GAgP (AAP, 1999);
  2. presence of ≥20 teeth;
  3. presence of ≥ 6 sites presenting PD ≥ 5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to other two non-contiguous teeth);
  4. good general health;
  5. ≤ 35 years old; and
  6. agree to participate in the study and sign a written informed consent. All subjects will be individually informed about the objectives, probable risks and benefits of the protocol treatment (according to Resolution nº196 of October 1996 and to the Professional Code of Dental Ethics - 179/93).

Exclusion Criteria:

  1. pregnancy or lactating;
  2. suffer from any systemic disease (e.g. cardiovascular disorders, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease;
  3. took antimicrobials in the previous 6 months;
  4. taking long-term anti-inflammatory drugs;
  5. previous periodontal treatment within the last 12 months;
  6. smokers.

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): NCT02969928


Locations
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Brazil
College of Dentistry - São José dos Campos, Sao Paulo State University
São José dos Campos, SP, Brazil, 12245-310
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Principal Investigator: Mauro P Santamaria, PhD Universidade Estadual Paulista Júlio de Mesquita Filho
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mauro Pedrine Santamaria, Professor, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT02969928    
Other Study ID Numbers: AmxMetClmCFA
First Posted: November 21, 2016    Key Record Dates
Results First Posted: September 7, 2020
Last Update Posted: September 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho:
Full-mouth ultrasonic debridement
Clarithromycin
Amoxicillin
Metronidazole
Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms
Amoxicillin
Metronidazole
Clarithromycin
Anti-Bacterial Agents
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