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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

Tracking Information
First Submitted Date  ICMJE July 8, 2016
First Posted Date  ICMJE July 12, 2016
Results First Submitted Date  ICMJE May 9, 2017
Results First Posted Date  ICMJE October 17, 2017
Last Update Posted Date November 21, 2017
Study Start Date  ICMJE March 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
Clinical Attachment Level [ Time Frame: 6 months ]
Distance from bottom of pocket to the cement-enamel junction (CEJ).
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2016)
Clinical Attachment Level [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
Probing Depth [ Time Frame: 6 months ]
Distance from the bottom of sulcus/pocket to gingival margin
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2016)
Probing Depth [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clarithromycin as Adjuvant to Periodontal Debridement
Official Title  ICMJE Clarithromycin as Adjuvant to Periodontal Debridement in the Treatment of Generalized Aggressive Periodontitis: Randomized Clinical Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Aggressive Periodontitis
Intervention  ICMJE
  • Drug: Clarithromycin
    Use of 500mg of Clarithromycin twice a day for 3 days
    Other Name: macrolide
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Clarithromycin
    • Other: One-stage full-mouth ultrasonic debridement (FMUD)
  • Placebo Comparator: placebo group
    20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
    Interventions:
    • Drug: Placebo
    • Other: One-stage full-mouth ultrasonic debridement (FMUD)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2016)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02829983
Other Study ID Numbers  ICMJE NMRBA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Undecided
Responsible Party Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
Study Sponsor  ICMJE Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators  ICMJE Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators  ICMJE
Study Director: Mauro P Santamaria, DDS, PhD UPECLIN HC FM Botucatu Unesp
PRS Account Universidade Estadual Paulista Júlio de Mesquita Filho
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP