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Measurement of Oncostatin M, Leukemia Inhibitory Factor and Interleukin-11 Levels of Patients With Periodontal Disease

Primary Purpose

Chronic Periodontitis, Generalized, Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Initial Periodontal Therapy
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Chronic Periodontitis, Generalized focused on measuring Chronic Periodontitis, Gingival Crevicular Fluid, Leukemia Inhibitory Factor, Oncostatin M, Interleukin-11, Periodontal Therapy, Gingivitis

Eligibility Criteria

20 Years - 56 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • systemically healthy
  • non-smokers

Exclusion Criteria:

  • smokers
  • pregnancy or lactation
  • individuals with any systemic disease
  • individuals who have had periodontal treatment in the last six months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Healthy

    Gingivitis

    Chronic Periodontitis

    Arm Description

    included individuals with probing depth (PD) ≤3mm, no sites with attachment loss, and no radiographic evidence of alveolar bone resorption. They exhibited no sign of inflammation (GI=0).

    had varying degrees of gingival inflammation (GI≥1), PD≤3mm with no clinical attachment loss or with no alveolar bone destruction.

    was defined as those who were with PD ≥ 4mm, clinical attachment loss (CAL) ≥ 2mm, and who had bone loss affecting >30% of the existing teeth on clinical and radiographic examination.

    Outcomes

    Primary Outcome Measures

    Clinical attachment level baseline
    As described by Silness&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Scores 0: No plaque. scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. Scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. Scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas/4 plaque index individual= scores from 28 tooth/28
    Plaque index baseline
    As described by Silness&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Scores 0: No plaque. scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. Scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. Scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas. plaque index individual= scores from 28 tooth
    Gingival index baseline
    As described by Löe&Silness 1963; The bleeding is assessed by probing gently along the wall of soft tissue of the gingival sulcus. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Score 0 - Normal, healthy gingival with sharp, non-inflamed margins. score 1 - Marginal gingivitis with minimal inflammation and edema at the free gingival. No bleeding on probing. Score 2 - Moderate gingivitis with a wider band of inflammation and bleeding upon probing. Score 3 - Advanced gingivitis with inflammation clinically reaching the mucogingival junction usually with ulceration. Score 0 considered healthy gingiva, score 3 assessed advanced gingival disease. gingival index for a tooth=scores from 4 areas/4 gingival index individual= scores from 28 tooth/28
    Probing of depth baseline
    Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe
    Biochemical outcomes baseline
    In this study, biochemical parameters including OSM,LIF, IL-11 were measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) methods on Gingival Crevicular Fluid, saliva and serum at baseline

    Secondary Outcome Measures

    Clinical attachment level after 8 weeks
    Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe
    Plaque index after 8 weeks
    As described by Silness&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Scores 0: No plaque scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. Scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. Scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas/4 plaque index individual= scores from 28 tooth/28
    Gingival index after 8 weeks
    As described by Löe&Silness 1963; The bleeding is assessed by probing gently along the wall of soft tissue of the gingival sulcus. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Score 0 - Normal, healthy gingival with sharp, non-inflamed margins. score 1 - Marginal gingivitis with minimal inflammation and edema at the free gingival. No bleeding on probing. Score 2 - Moderate gingivitis with a wider band of inflammation and bleeding upon probing. Score 3 - Advanced gingivitis with inflammation clinically reaching the mucogingival junction usually with ulceration. Score 0 considered healthy gingiva, score 3 assessed advanced gingival disease. gingival index for a tooth=scores from 4 areas/4 gingival index individual= scores from 28 tooth/28
    Probing of dept after 8 weeks
    Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe
    Biochemical outcomes after 8 weeks
    In this study, biochemical parameters including OSM,LIF, IL-11 were measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) methods on Gingival Crevicular Fluid, saliva and serum at 8 weeks

    Full Information

    First Posted
    October 6, 2020
    Last Updated
    October 15, 2020
    Sponsor
    Ataturk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04597073
    Brief Title
    Measurement of Oncostatin M, Leukemia Inhibitory Factor and Interleukin-11 Levels of Patients With Periodontal Disease
    Official Title
    Measurement of Oncostatin M, Leukemia Inhibitory Factor and Interleukin-11 Levels in Serum, Saliva, and Gingival Crevicular Fluid of Patients With Periodontal Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (Actual)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study aims to determine Oncostatin M (OSM), Leukemia inhibitory factor (LIF), and Interleukin-11 (IL-11) levels in gingival crevicular fluid (GCF), saliva, and serum in periodontally healthy individuals and those with gingivitis and chronic periodontitis before and after periodontal treatment and to evaluate the relationship between these cytokine levels and clinical periodontal parameters.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis, Generalized, Gingivitis
    Keywords
    Chronic Periodontitis, Gingival Crevicular Fluid, Leukemia Inhibitory Factor, Oncostatin M, Interleukin-11, Periodontal Therapy, Gingivitis

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy
    Arm Type
    No Intervention
    Arm Description
    included individuals with probing depth (PD) ≤3mm, no sites with attachment loss, and no radiographic evidence of alveolar bone resorption. They exhibited no sign of inflammation (GI=0).
    Arm Title
    Gingivitis
    Arm Type
    Experimental
    Arm Description
    had varying degrees of gingival inflammation (GI≥1), PD≤3mm with no clinical attachment loss or with no alveolar bone destruction.
    Arm Title
    Chronic Periodontitis
    Arm Type
    Experimental
    Arm Description
    was defined as those who were with PD ≥ 4mm, clinical attachment loss (CAL) ≥ 2mm, and who had bone loss affecting >30% of the existing teeth on clinical and radiographic examination.
    Intervention Type
    Procedure
    Intervention Name(s)
    Initial Periodontal Therapy
    Intervention Description
    Oral hygiene education, including the use of toothbrushes and dental floss and/or interproximal brushes, was given to them. After one week Chronic Periodontitis group received nonsurgical periodontal therapy consisting of scaling and root planing (quadrant by quadrant) using manual scalers and curettes under local anesthesia. No antibiotics or any medications were prescribed during the treatment. Periodontal treatment was performed by the same investigator
    Primary Outcome Measure Information:
    Title
    Clinical attachment level baseline
    Description
    As described by Silness&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Scores 0: No plaque. scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. Scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. Scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas/4 plaque index individual= scores from 28 tooth/28
    Time Frame
    baseline (before treatment)
    Title
    Plaque index baseline
    Description
    As described by Silness&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Scores 0: No plaque. scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. Scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. Scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas. plaque index individual= scores from 28 tooth
    Time Frame
    baseline (before treatment)
    Title
    Gingival index baseline
    Description
    As described by Löe&Silness 1963; The bleeding is assessed by probing gently along the wall of soft tissue of the gingival sulcus. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Score 0 - Normal, healthy gingival with sharp, non-inflamed margins. score 1 - Marginal gingivitis with minimal inflammation and edema at the free gingival. No bleeding on probing. Score 2 - Moderate gingivitis with a wider band of inflammation and bleeding upon probing. Score 3 - Advanced gingivitis with inflammation clinically reaching the mucogingival junction usually with ulceration. Score 0 considered healthy gingiva, score 3 assessed advanced gingival disease. gingival index for a tooth=scores from 4 areas/4 gingival index individual= scores from 28 tooth/28
    Time Frame
    baseline (before treatment)
    Title
    Probing of depth baseline
    Description
    Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe
    Time Frame
    baseline (before treatment)
    Title
    Biochemical outcomes baseline
    Description
    In this study, biochemical parameters including OSM,LIF, IL-11 were measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) methods on Gingival Crevicular Fluid, saliva and serum at baseline
    Time Frame
    baseline (before treatment)
    Secondary Outcome Measure Information:
    Title
    Clinical attachment level after 8 weeks
    Description
    Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe
    Time Frame
    8 weeks after treatment
    Title
    Plaque index after 8 weeks
    Description
    As described by Silness&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Scores 0: No plaque scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. Scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. Scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas/4 plaque index individual= scores from 28 tooth/28
    Time Frame
    8 weeks after treatment
    Title
    Gingival index after 8 weeks
    Description
    As described by Löe&Silness 1963; The bleeding is assessed by probing gently along the wall of soft tissue of the gingival sulcus. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Score 0 - Normal, healthy gingival with sharp, non-inflamed margins. score 1 - Marginal gingivitis with minimal inflammation and edema at the free gingival. No bleeding on probing. Score 2 - Moderate gingivitis with a wider band of inflammation and bleeding upon probing. Score 3 - Advanced gingivitis with inflammation clinically reaching the mucogingival junction usually with ulceration. Score 0 considered healthy gingiva, score 3 assessed advanced gingival disease. gingival index for a tooth=scores from 4 areas/4 gingival index individual= scores from 28 tooth/28
    Time Frame
    8 weeks after treatment
    Title
    Probing of dept after 8 weeks
    Description
    Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe
    Time Frame
    8 weeks after treatment
    Title
    Biochemical outcomes after 8 weeks
    Description
    In this study, biochemical parameters including OSM,LIF, IL-11 were measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) methods on Gingival Crevicular Fluid, saliva and serum at 8 weeks
    Time Frame
    8 weeks after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    56 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: systemically healthy non-smokers Exclusion Criteria: smokers pregnancy or lactation individuals with any systemic disease individuals who have had periodontal treatment in the last six months

    12. IPD Sharing Statement

    Learn more about this trial

    Measurement of Oncostatin M, Leukemia Inhibitory Factor and Interleukin-11 Levels of Patients With Periodontal Disease

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