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Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment

Primary Purpose

Generalized Aggressive Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
amoxicillin and metronidazole
Placebos
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Aggressive Periodontitis focused on measuring Aggressive periodontitis, anti-infective agents, debridement, randomized clinical trial, ultrasonic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of GAgP;
  • presence of 20 teeth;
  • presence of teeth presenting PD>5 mm with bleeding on probing (BOP) and 2 teeth 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.

Exclusion Criteria:

  • were pregnant or lactating;
  • were suffering from any other systemic diseases (e.g., cardiovascular, diabetes);
  • received antimicrobials in the previous 3 months;
  • were taking long-term anti-inflammatory drugs;
  • received a course of periodontal treatment within the last 6 months;
  • smoked

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Placebo Comparator

    Arm Label

    FMUD + AM

    FMUD

    SRP + AM

    SRP

    Arm Description

    One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days.

    One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.

    Four sessions (1/week) of scaling and root planning, plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the last session of treatment and taken every 8 hours for 7 days.

    Four sessions (1/week) of scaling and root planning, plus two distinct placebo pills prescribed on the last session of treatment and taken every 8 hours for 7 days.

    Outcomes

    Primary Outcome Measures

    Change of the baseline relative clinical attachment level at 6 months
    distance from the bottom of the pocket to the stent margin.

    Secondary Outcome Measures

    Change of the baseline probing depth at 6 months
    Distance from the bottom of pocket to gingival margin;
    Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) at 6 months
    Concentration of IL-1β, IL-10 released in gingival crevicular fluid
    Change in the microbial composition at 6 months
    Concentration of bacteria in the subgingival biofilm

    Full Information

    First Posted
    April 29, 2019
    Last Updated
    May 9, 2019
    Sponsor
    University of Campinas, Brazil
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03933501
    Brief Title
    Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment
    Official Title
    The Use of Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2006 (Actual)
    Primary Completion Date
    December 1, 2008 (Actual)
    Study Completion Date
    December 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Campinas, Brazil

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    This study is designed as a parallel, masked, randomized, placebo-controlled clinical trial to assess the clinical, microbiological, and immunological outcomes of scaling and root planning (SRP) or full-mouth ultrasonic debridement (FMUD) with AM (Amoxicillin + Metronidazole) for the treatment of Generalized Aggressive Periodontitis (GAgP).
    Detailed Description
    Forty eight GAgP patients were divided into 4 groups: the SRP group (n = 12), which received SRP plus placebo, and the SRP+AM group (n = 12), which received SRP and 375mg amoxicillin plus 250 mg metronidazole for 7 days, the FMUD group (n = 12), which received FMUD plus placebo, and the FMUD+AM group (n = 12), which received FMUD and 375mg amoxicillin plus 250 mg metronidazole for 7 days. The following clinical outcomes were tested: plaque and bleeding on probing indices, pocket probing depth (PD), relative gingival margin position (GMP), and relative clinical attachment level (CAL). The total amount of Porphyromonas gingivalis (Pg), Aggregatibacter actinomycetemcomitans (Aa), Tannerella forsythia (Tf), and gingival crevicular fluid (GCF) concentration of interleukin (IL)-10 and IL-1b were also determined. All clinical, microbiological, and immunological parameters were assessed at baseline and at 3 and 6 months post-therapy. The ANOVA/Tukey test was used for statistical analysis (a = 5%).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Generalized Aggressive Periodontitis
    Keywords
    Aggressive periodontitis, anti-infective agents, debridement, randomized clinical trial, ultrasonic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FMUD + AM
    Arm Type
    Experimental
    Arm Description
    One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days.
    Arm Title
    FMUD
    Arm Type
    Placebo Comparator
    Arm Description
    One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.
    Arm Title
    SRP + AM
    Arm Type
    Experimental
    Arm Description
    Four sessions (1/week) of scaling and root planning, plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the last session of treatment and taken every 8 hours for 7 days.
    Arm Title
    SRP
    Arm Type
    Placebo Comparator
    Arm Description
    Four sessions (1/week) of scaling and root planning, plus two distinct placebo pills prescribed on the last session of treatment and taken every 8 hours for 7 days.
    Intervention Type
    Drug
    Intervention Name(s)
    amoxicillin and metronidazole
    Intervention Description
    375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Intervention Description
    Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.
    Primary Outcome Measure Information:
    Title
    Change of the baseline relative clinical attachment level at 6 months
    Description
    distance from the bottom of the pocket to the stent margin.
    Time Frame
    Baseline, 3 months and 6 months
    Secondary Outcome Measure Information:
    Title
    Change of the baseline probing depth at 6 months
    Description
    Distance from the bottom of pocket to gingival margin;
    Time Frame
    Baseline, 3 months and 6 months
    Title
    Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) at 6 months
    Description
    Concentration of IL-1β, IL-10 released in gingival crevicular fluid
    Time Frame
    Baseline, 3 months and 6 months
    Title
    Change in the microbial composition at 6 months
    Description
    Concentration of bacteria in the subgingival biofilm
    Time Frame
    Baseline, 3 months and 6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of GAgP; presence of 20 teeth; presence of teeth presenting PD>5 mm with bleeding on probing (BOP) and 2 teeth 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. Exclusion Criteria: were pregnant or lactating; were suffering from any other systemic diseases (e.g., cardiovascular, diabetes); received antimicrobials in the previous 3 months; were taking long-term anti-inflammatory drugs; received a course of periodontal treatment within the last 6 months; smoked

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31448837
    Citation
    Taiete T, Monteiro MF, Casati MZ, do Vale HF, Ambosano GMB, Nociti FH, Sallum EA, Casarin RCV. Local IL-10 level as a predictive factor in generalized aggressive periodontitis treatment response. Scand J Immunol. 2019 Dec;90(6):e12816. doi: 10.1111/sji.12816. Epub 2019 Oct 3.
    Results Reference
    derived

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    Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment

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