search
Back to results

Nonsurgical Periodontal Treatment Associated or Not With Systemic Antibiotics and Photodynamic Therapy

Primary Purpose

Aggressive Periodontitis, Generalized

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
periodontal debridement
photodynamic therapy
systemic clarithromycin
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, Generalized focused on measuring clarithromycin, photodynamic therapy, Antimicrobial therapy, Periodontal pocket

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosis of GagP
  • presence of ≥20 teeth
  • <35 years of age
  • periodontal pockets with probing depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm with concomitant bleeding on probing (BOP) in single-rooted teeth from different quadrants - 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 3

    Arm 4

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Periodontal debridement

    Periodontal debridement + CLM

    Periodontal debridement + PDT

    Periodontal debridement + CLM + PDT

    Arm Description

    Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).

    Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours) for 3 days.

    Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days) and a single application of PDT (Photodynamic Therapy).

    Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours for 3 days) and single application of PDT.

    Outcomes

    Primary Outcome Measures

    Clinical attachment level
    distance from bottom of pocket to the cement-enamel junction

    Secondary Outcome Measures

    Probing depth
    distance from the bottom of sulcus/pocket to gingival margin

    Full Information

    First Posted
    May 2, 2017
    Last Updated
    May 4, 2017
    Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03142776
    Brief Title
    Nonsurgical Periodontal Treatment Associated or Not With Systemic Antibiotics and Photodynamic Therapy
    Official Title
    Evaluation of the Local Effect of Nonsurgical Periodontal Treatment of Generalized Aggressive Periodontitis Associated or Not With Systemic Antibiotics and Photodynamic Therapy.: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To assess the local effect of the antimicrobial therapy using clarithromycin association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP).
    Detailed Description
    The aim of the present study was to evaluate the local effect of the antimicrobial therapy using clarithromycin (CLM) association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP). Sixty periodontal pockets were select and randomly assigned into four groups: Periodontal Debridement (PD) (n=15): periodontal pockets that received periodontal debridement (PD) with placebo; PD+CLM (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin; PD+PDT (n=15): periodontal pockets that received periodontal debridement associated with photodynamic therapy; PD+CLM+PDT (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin and photodynamic therapy. 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, Generalized
    Keywords
    clarithromycin, photodynamic therapy, Antimicrobial therapy, Periodontal pocket

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Periodontal debridement
    Arm Type
    Placebo Comparator
    Arm Description
    Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
    Arm Title
    Periodontal debridement + CLM
    Arm Type
    Active Comparator
    Arm Description
    Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours) for 3 days.
    Arm Title
    Periodontal debridement + PDT
    Arm Type
    Active Comparator
    Arm Description
    Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days) and a single application of PDT (Photodynamic Therapy).
    Arm Title
    Periodontal debridement + CLM + PDT
    Arm Type
    Active Comparator
    Arm Description
    Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours for 3 days) and single application of PDT.
    Intervention Type
    Procedure
    Intervention Name(s)
    periodontal debridement
    Other Intervention Name(s)
    Ultrassonic periodontal debridement
    Intervention Type
    Procedure
    Intervention Name(s)
    photodynamic therapy
    Other Intervention Name(s)
    antimicrobial photodynamic therapy
    Intervention Type
    Drug
    Intervention Name(s)
    systemic clarithromycin
    Other Intervention Name(s)
    antibiotic
    Primary Outcome Measure Information:
    Title
    Clinical attachment level
    Description
    distance from bottom of pocket to the cement-enamel junction
    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 GagP presence of ≥20 teeth <35 years of age periodontal pockets with probing depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm with concomitant bleeding on probing (BOP) in single-rooted teeth from different quadrants - 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
    Citations:
    PubMed Identifier
    24493231
    Citation
    Arweiler NB, Pietruska M, Pietruski J, Skurska A, Dolinska E, Heumann C, Auschill TM, Sculean A. Six-month results following treatment of aggressive periodontitis with antimicrobial photodynamic therapy or amoxicillin and metronidazole. Clin Oral Investig. 2014 Dec;18(9):2129-35. doi: 10.1007/s00784-014-1193-6. Epub 2014 Feb 4.
    Results Reference
    background

    Learn more about this trial

    Nonsurgical Periodontal Treatment Associated or Not With Systemic Antibiotics and Photodynamic Therapy

    We'll reach out to this number within 24 hrs