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The Effect of Periodontal Treatment on Stress and Pregnancy Relationship

Primary Purpose

Pregnancy Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
Saliva samples
GCF samples
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Gingivitis focused on measuring Stress

Eligibility Criteria

24 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • being between the ages of 24-50
  • being pregnant for 23-30 weeks (for pregnant individuals)
  • not smoking.

Exclusion Criteria:

  • using antimicrobial or anti-inflammatory therapy within the previous 3 months,
  • having systemic disease,
  • having periodontitis,
  • having deep caries lesions, and remnant roots and
  • having lactation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Pregnancy Group

    Non-Pregnancy Group

    Arm Description

    GCF and saliva samples were taken from pregnant gingivitis patients before treatment and after 8 weeks. GCF and saliva samples were taken from pregnant periodontal healty individuals baseline and after 8 weeks. Intervention: Non-surgical periodontal treatment was performed for pregnant gingivitis patients. Gingival crevicular fluid (GCF) and saliva samples were taken.

    GCF and saliva samples were taken from non-pregnant gingivitis patients before treatment and after 8 weeks. GCF and saliva samples were taken from periodontal healty individuals baseline and after 8 weeks. Intervention: Non-surgical periodontal treatment was performed for non-pregnant gingivitis patients. Gingival crevicular fluid (GCF) and saliva samples were taken.

    Outcomes

    Primary Outcome Measures

    Dehydroepiandrosterone (DHEA)
    The changes in DHEA levels within 8 weeks. Higher values represent a worse outcome. The decrease in DHEA levels is expected after periodontal treatment.
    estrogen
    The changes in estrogen levels within 8 weeks. Higher values represent a worse outcome. The decrease in estrogen levels is expected after periodontal treatment.

    Secondary Outcome Measures

    Gingival index
    The changes in gingival index level after periodontal treatment. Gingival index was measured for determining the severity of disease and clinical outcome. Higher values represent a worse outcome. After periodontal treatment, a reduction in gingival index value is expected.

    Full Information

    First Posted
    March 18, 2020
    Last Updated
    March 19, 2020
    Sponsor
    Tokat Gaziosmanpasa University
    Collaborators
    Abant Izzet Baysal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04315532
    Brief Title
    The Effect of Periodontal Treatment on Stress and Pregnancy Relationship
    Official Title
    Relationship of Sex Steroid and Stress Markers in Saliva and Gingival Crevicular Fluid With Pregnancy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (Actual)
    Primary Completion Date
    October 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tokat Gaziosmanpasa University
    Collaborators
    Abant Izzet Baysal University

    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
    There is a relationship between stress and pregnancy gingivitis. This relationship may be double-sided.
    Detailed Description
    The aim of this clinical study was to determine the effect of non-surgical mechanical periodontal treatment on sex steroid and stress markers at pregnancy gingivitis. A total of 84 subjects; 22 pregnant women with gingivitis (group 1) and 25 pregnant women with periodontal healthy (pregnant group), group 2), 22 non-pregnant women with gingivitis (group 3) and 15 non-pregnant women with periodontal healthy (non-pregnant group), group 4) participated in this study. Clinically, plaque index, gingival index, and probing pocket depth were measured at baseline and after therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnancy Gingivitis
    Keywords
    Stress

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pregnancy Group
    Arm Type
    Active Comparator
    Arm Description
    GCF and saliva samples were taken from pregnant gingivitis patients before treatment and after 8 weeks. GCF and saliva samples were taken from pregnant periodontal healty individuals baseline and after 8 weeks. Intervention: Non-surgical periodontal treatment was performed for pregnant gingivitis patients. Gingival crevicular fluid (GCF) and saliva samples were taken.
    Arm Title
    Non-Pregnancy Group
    Arm Type
    Active Comparator
    Arm Description
    GCF and saliva samples were taken from non-pregnant gingivitis patients before treatment and after 8 weeks. GCF and saliva samples were taken from periodontal healty individuals baseline and after 8 weeks. Intervention: Non-surgical periodontal treatment was performed for non-pregnant gingivitis patients. Gingival crevicular fluid (GCF) and saliva samples were taken.
    Intervention Type
    Other
    Intervention Name(s)
    Non-surgical periodontal treatment
    Intervention Description
    Non-surgical periodontal treatment was performed for pregnant and non-pregnant gingivitis patients. Gingival crevicular fluid (GCF) and saliva samples were taken from all patients baseline and after 8 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Saliva samples
    Intervention Description
    Saliva samples were taken from patients for the evaluation of sex steroid and stress markers baseline and after 8 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    GCF samples
    Intervention Description
    GCF samples were taken from patients for the evaluation of stress markers baseline and after 8 weeks.
    Primary Outcome Measure Information:
    Title
    Dehydroepiandrosterone (DHEA)
    Description
    The changes in DHEA levels within 8 weeks. Higher values represent a worse outcome. The decrease in DHEA levels is expected after periodontal treatment.
    Time Frame
    Baseline and after 8 weeks
    Title
    estrogen
    Description
    The changes in estrogen levels within 8 weeks. Higher values represent a worse outcome. The decrease in estrogen levels is expected after periodontal treatment.
    Time Frame
    Baseline and after 8 weeks
    Secondary Outcome Measure Information:
    Title
    Gingival index
    Description
    The changes in gingival index level after periodontal treatment. Gingival index was measured for determining the severity of disease and clinical outcome. Higher values represent a worse outcome. After periodontal treatment, a reduction in gingival index value is expected.
    Time Frame
    Baseline and after 8 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    24 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: being between the ages of 24-50 being pregnant for 23-30 weeks (for pregnant individuals) not smoking. Exclusion Criteria: using antimicrobial or anti-inflammatory therapy within the previous 3 months, having systemic disease, having periodontitis, having deep caries lesions, and remnant roots and having lactation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ozge Gokturk
    Organizational Affiliation
    Abant Izzet Baysal
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Periodontal Treatment on Stress and Pregnancy Relationship

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