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Stress and Gingival Inflammation in Non-pregnant and Pregnant Women

Primary Purpose

Periodontal Diseases, Pregnancy Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
periodontal treatment
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring chromogranin A, stress, gingivitis, pregnancy

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Must be systemically healthy;
  2. Must be at least twenty teeth in the mouth;
  3. Clinical diagnosis of gingivitis;
  4. Must be the probing pocket depth (PPD)≤3 mm in all four quadrants.

Exclusion Criteria:

  • the use of anti-inflammatory,
  • antimicrobial and hormone therapy within the preceding 6 months,
  • having psychiatric disorders,
  • a systemic disease,
  • smoking cigarettes and
  • for the control group breastfeeding, pregnancy and menstrual periods.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pregnant group

    Non-Pregnant

    Arm Description

    Test group, non-surgical periodontal therapy (NPT) consisted of scaling and oral hygiene instruction was applied. IL- 1β AND IL-10 in the GCF and Cg A in saliva samples were taken before and after periodontal treatment.

    Control group, non-surgical periodontal therapy (NPT) consisted of scaling and oral hygiene instruction was applied. IL- 1β AND IL-10 in the GCF and Cg A in saliva samples were taken before and after periodontal treatment.

    Outcomes

    Primary Outcome Measures

    salivary Cg A hormone concentration
    Samples should be taken before and after treatment and evaluated using ELISA kits

    Secondary Outcome Measures

    IL-1β and IL-10 Cytokine levels in the GCF
    Samples should be taken before and after treatment and evaluated using ELISA kits

    Full Information

    First Posted
    November 2, 2017
    Last Updated
    November 6, 2017
    Sponsor
    Tokat Gaziosmanpasa University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03336957
    Brief Title
    Stress and Gingival Inflammation in Non-pregnant and Pregnant Women
    Official Title
    Effect of Non-Surgical Periodontal Therapy on Pregnancy-Related Degree of Gingival Inflammation and Stress Markers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (undefined)
    Primary Completion Date
    January 1, 2017 (Actual)
    Study Completion Date
    January 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tokat Gaziosmanpasa University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Background: The purpose of the present study is to research whether stress scale scores alter with relationship to gingival inflammation and examine the impact of non-surgical periodontal therapy during pregnancy on the levels of cytokines in gingival crevicular fluid (GCF) and on salivary stress-related hormones. Methods: 30 non-pregnant (control group) and 30 pregnant women (test group) who fulfilled the study inclusion criteria were chosen. The participants with moderate/severe gingivitis were included. Clinical data and samples of GCF and salivary were collected at baseline and after periodontal therapy. The levels of cytokines interleukin-1 beta (IL-1β) and IL-10, and concentration of salivary chromogranin A (Cg A) hormone were analyzed by enzyme-linked immunosorbent assay kits.
    Detailed Description
    Periodontal clinical measurements and periodontal treatment were applied by a previously trained and calibrated examiner. Clinical parameters measurements including; probing pocket depths (PPD; the distance from the gingival margin to the base of the gingival sulcus), clinical attachment level (CAL), full mouth gingival index (GI)21 and plaque index (PI)20 scores using a periodontal probe were registered following saliva and GCF sample collection. Then, non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction was applied. Clinical measurements, recruitment of GCF, and saliva samples were repeated after three weeks. Gingival Crevicular Fluid and Saliva Sample Collection Selected anterior teeth for GCF sampling were isolated from saliva using cotton rolls, a gentle stream of air was conducted parallel to the root surface for 5 to 10 seconds to dry the area. The periopaper strips were gently inserted into the gingival crevice until resistance was felt and were left in place for 30 s and were collected from mesio-buccal sulcus of teeth in the anterior region of each patient (two samples per patient and per visit). The samples containing blood were discarded and were placed in sterile Eppendorf tubes and were stored at -20°C until the assay procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Diseases, Pregnancy Gingivitis
    Keywords
    chromogranin A, stress, gingivitis, pregnancy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    2 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pregnant group
    Arm Type
    Experimental
    Arm Description
    Test group, non-surgical periodontal therapy (NPT) consisted of scaling and oral hygiene instruction was applied. IL- 1β AND IL-10 in the GCF and Cg A in saliva samples were taken before and after periodontal treatment.
    Arm Title
    Non-Pregnant
    Arm Type
    Active Comparator
    Arm Description
    Control group, non-surgical periodontal therapy (NPT) consisted of scaling and oral hygiene instruction was applied. IL- 1β AND IL-10 in the GCF and Cg A in saliva samples were taken before and after periodontal treatment.
    Intervention Type
    Procedure
    Intervention Name(s)
    periodontal treatment
    Intervention Description
    non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction
    Primary Outcome Measure Information:
    Title
    salivary Cg A hormone concentration
    Description
    Samples should be taken before and after treatment and evaluated using ELISA kits
    Time Frame
    up to 8 weeks
    Secondary Outcome Measure Information:
    Title
    IL-1β and IL-10 Cytokine levels in the GCF
    Description
    Samples should be taken before and after treatment and evaluated using ELISA kits
    Time Frame
    up to 8 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Must be systemically healthy; Must be at least twenty teeth in the mouth; Clinical diagnosis of gingivitis; Must be the probing pocket depth (PPD)≤3 mm in all four quadrants. Exclusion Criteria: the use of anti-inflammatory, antimicrobial and hormone therapy within the preceding 6 months, having psychiatric disorders, a systemic disease, smoking cigarettes and for the control group breastfeeding, pregnancy and menstrual periods.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    individual participant data for all primary and secondary outcome measures will be made available.
    Citations:
    PubMed Identifier
    30043934
    Citation
    Yarkac FU, Gokturk O, Demir O. Effect of non-surgical periodontal therapy on the degree of gingival inflammation and stress markers related to pregnancy. J Appl Oral Sci. 2018 Jul 23;26:e20170630. doi: 10.1590/1678-7757-2017-0630.
    Results Reference
    derived

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    Stress and Gingival Inflammation in Non-pregnant and Pregnant Women

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