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Clarithromycin as Adjuvant to Periodontal Debridement

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ClinicalTrials.gov Identifier: NCT02829983
Recruitment Status : Completed
First Posted : July 12, 2016
Results First Posted : October 17, 2017
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

Study Description
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Brief Summary:
To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.

Condition or disease Intervention/treatment Phase
Aggressive Periodontitis Drug: Clarithromycin Drug: Placebo Other: One-stage full-mouth ultrasonic debridement (FMUD) Not Applicable

Detailed Description:
To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.Forty patients were select and randomly assigned into two groups: Group clarithromycin with 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days; group placebo with 20 subjects that received FMUD associated with placebo. Probing depth (PD), gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Clarithromycin as Adjuvant to Periodontal Debridement in the Treatment of Generalized Aggressive Periodontitis: Randomized Clinical Trial
Study Start Date : March 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2015

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: clarithromycin group
20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.
 Drug: Clarithromycin
Use of 500mg of Clarithromycin twice a day for 3 days
Other Name: macrolide

Other: One-stage full-mouth ultrasonic debridement (FMUD)
One session of Periodontal debridement using ultrasonic device.
Placebo Comparator: placebo group
20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
 Drug: Placebo
Use of placebo tablets twice a day for 3 days.

Other: One-stage full-mouth ultrasonic debridement (FMUD)
One session of Periodontal debridement using ultrasonic device.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Attachment Level [ Time Frame: 6 months ]
    Distance from bottom of pocket to the cement-enamel junction (CEJ).


Secondary Outcome Measures :
  1. Probing Depth [ Time Frame: 6 months ]
    Distance from the bottom of sulcus/pocket to gingival margin


Eligibility Criteria
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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 Generalized Aggressive Periodontitis
  • presence of ≥20 teeth
  • presence of ≥ 6 sites presenting probing depth (PD) ≥5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to two other non-contiguous teeth between them)
  • good general health
  • <35 years of age
  • agree to participate in the study and sign a written consent

Exclusion Criteria:

  • pregnant or lactating
  • suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
  • received antimicrobials in the previous 6 months
  • taking long-term anti-inflammatory drugs
  • received a course of periodontal treatment within the last 12 months
  • smoked
Contacts and Locations
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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): NCT02829983


Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
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Study Director: Mauro P Santamaria, DDS, PhD UPECLIN HC FM Botucatu Unesp
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mauro Pedrine Santamaria, DDS,MS,PhD, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT02829983    
Other Study ID Numbers: NMRBA
First Posted: July 12, 2016    Key Record Dates
Results First Posted: October 17, 2017
Last Update Posted: November 21, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided
Keywords provided by Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho:
clarithromycin
periodontal debridement
aggressive periodontitis
Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms
Clarithromycin
 Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors