search
Back to results

Clarithromycin as Adjuvant to Periodontal Debridement

Primary Purpose

Aggressive Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clarithromycin
Placebo
One-stage full-mouth ultrasonic debridement (FMUD)
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aggressive Periodontitis focused on measuring clarithromycin, periodontal debridement, aggressive periodontitis

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    clarithromycin group

    placebo group

    Arm Description

    20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.

    20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).

    Outcomes

    Primary Outcome Measures

    Clinical Attachment Level
    Distance from bottom of pocket to the cement-enamel junction (CEJ).

    Secondary Outcome Measures

    Probing Depth
    Distance from the bottom of sulcus/pocket to gingival margin

    Full Information

    First Posted
    July 8, 2016
    Last Updated
    October 18, 2017
    Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho
    Collaborators
    Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02829983
    Brief Title
    Clarithromycin as Adjuvant to Periodontal Debridement
    Official Title
    Clarithromycin as Adjuvant to Periodontal Debridement in the Treatment of Generalized Aggressive Periodontitis: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho
    Collaborators
    Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aggressive Periodontitis
    Keywords
    clarithromycin, periodontal debridement, aggressive periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    clarithromycin group
    Arm Type
    Active Comparator
    Arm Description
    20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.
    Arm Title
    placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
    Intervention Type
    Drug
    Intervention Name(s)
    Clarithromycin
    Other Intervention Name(s)
    macrolide
    Intervention Description
    Use of 500mg of Clarithromycin twice a day for 3 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Use of placebo tablets twice a day for 3 days.
    Intervention Type
    Other
    Intervention Name(s)
    One-stage full-mouth ultrasonic debridement (FMUD)
    Intervention Description
    One session of Periodontal debridement using ultrasonic device.
    Primary Outcome Measure Information:
    Title
    Clinical Attachment Level
    Description
    Distance from bottom of pocket to the cement-enamel junction (CEJ).
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Probing Depth
    Description
    Distance from the bottom of sulcus/pocket to gingival margin
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mauro P Santamaria, DDS, PhD
    Organizational Affiliation
    UPECLIN HC FM Botucatu Unesp
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Undecided
    Citations:
    PubMed Identifier
    22288485
    Citation
    Casarin RC, Peloso Ribeiro ED, Sallum EA, Nociti FH Jr, Goncalves RB, Casati MZ. The combination of amoxicillin and metronidazole improves clinical and microbiologic results of one-stage, full-mouth, ultrasonic debridement in aggressive periodontitis treatment. J Periodontol. 2012 Aug;83(8):988-98. doi: 10.1902/jop.2012.110513. Epub 2012 Jan 30.
    Results Reference
    result
    PubMed Identifier
    34790237
    Citation
    Hammami C, Nasri W. Antibiotics in the Treatment of Periodontitis: A Systematic Review of the Literature. Int J Dent. 2021 Nov 8;2021:6846074. doi: 10.1155/2021/6846074. eCollection 2021.
    Results Reference
    derived
    PubMed Identifier
    33197289
    Citation
    Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.
    Results Reference
    derived
    PubMed Identifier
    28671507
    Citation
    Andere NMRB, Castro Dos Santos NC, Araujo CF, Mathias IF, Taiete T, Casarin RCV, Jardini MAN, Shaddox LM, Santamaria MP. Clarithromycin as an Adjunct to One-Stage Full-Mouth Ultrasonic Periodontal Debridement in Generalized Aggressive Periodontitis: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Dec;88(12):1244-1252. doi: 10.1902/jop.2017.170165. Epub 2017 Jul 3.
    Results Reference
    derived

    Learn more about this trial

    Clarithromycin as Adjuvant to Periodontal Debridement

    We'll reach out to this number within 24 hrs