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Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis)

Primary Purpose

Aggressive Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
antimicrobial photodynamic therapy
systemic antibiotics
Sponsored by
University of Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aggressive Periodontitis focused on measuring Photodynamic therapy, Antibiotic therapy

Eligibility Criteria

18 Years - 38 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: aggressive periodontitis (stage III, grade C periodontitis) nonsmokers at least 20 teeth in oral cavity systemically healthy Exclusion Criteria: any previous periodontal treatment smoking pregnancy ingestion of systemic antibiotics within three months before therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    ANTIMICROBIAL PHOTODYNAMIC THERAPY

    SYSTEMIC ANTIBIOTICS

    Arm Description

    The patients received antimicrobial photodynamic therapy after non-surgical periodontal treatment

    The patients received systemic antibiotics after non-surgical periodontal treatment

    Outcomes

    Primary Outcome Measures

    Probing depth reduction
    Change in probing depth
    Bleeding on probing
    Bleeding after measurement of probing depth

    Secondary Outcome Measures

    Clinical attachment loss
    Change in clinical attachment

    Full Information

    First Posted
    November 23, 2022
    Last Updated
    December 8, 2022
    Sponsor
    University of Ljubljana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05655338
    Brief Title
    Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis)
    Official Title
    Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis): A Comparison Between Photodynamic Therapy and Antibiotic Therapy as an Adjunct to Non-Surgical Periodontal Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 2015 (Actual)
    Primary Completion Date
    June 30, 2016 (Actual)
    Study Completion Date
    June 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Ljubljana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.
    Detailed Description
    Background: Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Materials and methods: Twenty subjects with untreated aggressive periodontitis (stage III, grade C periodontitis) were divided into two groups: the test group (TG) received non-surgical therapy and two sessions of aPDT using a laser (HELBO TheraLite laser) with a wavelength of 670nm associated with HELBO Blue photosensitizer, and the control group (CG) received non-surgical therapy and antibiotics (amoxicillin 500mg and metronidazole 400mg, 7 days). Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aggressive Periodontitis
    Keywords
    Photodynamic therapy, Antibiotic therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Masking Description
    The blindness of the examiner was ensured by restriction of access to the patients' data. Only the supervisor (MP) had access to the allocation data and therefore knew which patients received additional aPDT treatment. Periodontal examinations of 5 randomly selected individuals were carried out twice by the same examiner, and the second measurements were repeated after two weeks. The reproducibility of assessing all periodontal parameters was tested. Intra-examiner calibration scores were 0.95.
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ANTIMICROBIAL PHOTODYNAMIC THERAPY
    Arm Type
    Experimental
    Arm Description
    The patients received antimicrobial photodynamic therapy after non-surgical periodontal treatment
    Arm Title
    SYSTEMIC ANTIBIOTICS
    Arm Type
    Experimental
    Arm Description
    The patients received systemic antibiotics after non-surgical periodontal treatment
    Intervention Type
    Device
    Intervention Name(s)
    antimicrobial photodynamic therapy
    Other Intervention Name(s)
    HELBO TheraLite Laser
    Intervention Type
    Drug
    Intervention Name(s)
    systemic antibiotics
    Other Intervention Name(s)
    Amoxicillin (Hiconcil), Metronidazole (Efloran)
    Primary Outcome Measure Information:
    Title
    Probing depth reduction
    Description
    Change in probing depth
    Time Frame
    3 months
    Title
    Bleeding on probing
    Description
    Bleeding after measurement of probing depth
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Clinical attachment loss
    Description
    Change in clinical attachment
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: aggressive periodontitis (stage III, grade C periodontitis) nonsmokers at least 20 teeth in oral cavity systemically healthy Exclusion Criteria: any previous periodontal treatment smoking pregnancy ingestion of systemic antibiotics within three months before therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Boris Gaspirc, Assoc.prof.
    Organizational Affiliation
    University of Ljubljana
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis)

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