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The Effect of Time on the Outcome of Periodontal Treatment.

Primary Purpose

Periodontitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Periodontal treatment
Sponsored by
251 Hellenic Air Force & VA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periodontitis focused on measuring Periodontitis, Re-evaluation, Non-surgical periodontal treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Systematically healthy adults Informed consent form completion Periodontitis Diagnosis Patients not having received periodontal treatment since 12 months before Exclusion Criteria: Medical History that interferes with wound healing Antibiotic and anti-inflammatory drugs intake Medication that induces gingival enlargement Pregnancy/ Lactation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Periodontitis patients

    Arm Description

    Periodontitis patients receiving non-surgical periodontal treatment.

    Outcomes

    Primary Outcome Measures

    Probing Pocket Depth 0
    The distance between the gingival margin and the base of the sulcus/pocket
    Probing Pocket Depth 1
    The distance between the gingival margin and the base of the sulcus/pocket
    Probing Pocket Depth 2
    The distance between the gingival margin and the base of the sulcus/pocket
    Probing Pocket Depth 3
    The distance between the gingival margin and the base of the sulcus/pocket

    Secondary Outcome Measures

    Clinical attachment level
    The distance between cementoenamel junction and the base of the sulcus/pocket
    Plaque Index
    Number of sites with presence of dental plaque/ total number of sites
    Bleeding on Probing
    Number of sites with presence of bleeding/total number of sites
    Tooth Mobility
    degree of tooth mobility
    Furcation involvement
    Presence or absence of furcation involvement and degree of furcation defect
    matrix metalloproteinase
    matrix metalloproteinase 8 levels in whole saliva
    Oral Health Impact Profile (OHIP)-14 Questionnaire
    Questionnaire

    Full Information

    First Posted
    November 28, 2022
    Last Updated
    July 11, 2023
    Sponsor
    251 Hellenic Air Force & VA General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05643287
    Brief Title
    The Effect of Time on the Outcome of Periodontal Treatment.
    Official Title
    The Effect of Time on the Outcome of Periodontal Treatment.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    251 Hellenic Air Force & VA General Hospital

    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
    Re-evaluation after non-surgical periodontal treatment remains an integral part of comprehensive periodontal therapy. This re-evaluation determines if a patient is in need either of surgical periodontal therapy or a personalized program of supportive periodontal treatment. However important, this time point is yet to be determined.This interventional study aims to clarify which is the best time to re-evaluate the therapeutic result after non-surgical periodontal treatment.
    Detailed Description
    This randomized clinical trial aims to clarify which is the best time to re-evaluate the therapeutic result after non-surgical periodontal treatment. For this purpose the participants will be recruited among people who come to the Periodontal Department of 251 Hellenic Air Force Hospital for periodontal treatment. Each participant is going to submit informed consent in order to be included in the study. Patients with the diagnosis of Periodontitis will be submitted to non-surgical periodontal treatment with ultrasonic and manual scalers within two sessions, under local anaesthesia. The result of the treatment is going to be evaluated at 6, 12 and 24 weeks after treatment completion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis
    Keywords
    Periodontitis, Re-evaluation, Non-surgical periodontal treatment

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Periodontitis patients
    Arm Type
    Experimental
    Arm Description
    Periodontitis patients receiving non-surgical periodontal treatment.
    Intervention Type
    Procedure
    Intervention Name(s)
    Periodontal treatment
    Intervention Description
    Non-surgical periodontal treatment
    Primary Outcome Measure Information:
    Title
    Probing Pocket Depth 0
    Description
    The distance between the gingival margin and the base of the sulcus/pocket
    Time Frame
    Baseline
    Title
    Probing Pocket Depth 1
    Description
    The distance between the gingival margin and the base of the sulcus/pocket
    Time Frame
    6 weeks after periodontal treatment
    Title
    Probing Pocket Depth 2
    Description
    The distance between the gingival margin and the base of the sulcus/pocket
    Time Frame
    12 weeks after periodontal treatment
    Title
    Probing Pocket Depth 3
    Description
    The distance between the gingival margin and the base of the sulcus/pocket
    Time Frame
    24 weeks after periodontal treatment
    Secondary Outcome Measure Information:
    Title
    Clinical attachment level
    Description
    The distance between cementoenamel junction and the base of the sulcus/pocket
    Time Frame
    Baseline, 6, 12, 24 weeks after treatment
    Title
    Plaque Index
    Description
    Number of sites with presence of dental plaque/ total number of sites
    Time Frame
    Baseline, 6, 12, 24 weeks after treatment
    Title
    Bleeding on Probing
    Description
    Number of sites with presence of bleeding/total number of sites
    Time Frame
    Baseline, 6, 12, 24 weeks after treatment
    Title
    Tooth Mobility
    Description
    degree of tooth mobility
    Time Frame
    Baseline, 6, 12, 24 weeks after treatment
    Title
    Furcation involvement
    Description
    Presence or absence of furcation involvement and degree of furcation defect
    Time Frame
    Baseline, 6, 12, 24 weeks after treatment
    Title
    matrix metalloproteinase
    Description
    matrix metalloproteinase 8 levels in whole saliva
    Time Frame
    Baseline, 6, 12, 24 weeks after treatment
    Title
    Oral Health Impact Profile (OHIP)-14 Questionnaire
    Description
    Questionnaire
    Time Frame
    Baseline, 6, 12, 24 weeks after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Systematically healthy adults Informed consent form completion Periodontitis Diagnosis Patients not having received periodontal treatment since 12 months before Exclusion Criteria: Medical History that interferes with wound healing Antibiotic and anti-inflammatory drugs intake Medication that induces gingival enlargement Pregnancy/ Lactation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Georgia Malamoudi, DDS,MSc
    Phone
    6983394983
    Ext
    0030
    Email
    georgia.malamoudi@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    George Koukos, DDS,PhD
    Phone
    6983520282
    Ext
    0030
    Email
    gkoukos1977@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    George Koukos, DDS, PhD
    Organizational Affiliation
    251 Hellenic Air Force & VA Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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