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Completed

NCT Number: NCT04597073

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INITIAL PERIODONTAL THERAPY

Procedure

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 outcomes

  1. Clinical attachment level baseline

    Time frame: baseline (before treatment)

    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

  2. Plaque index baseline

    Time frame: baseline (before treatment)

    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

  3. Gingival index baseline

    Time frame: baseline (before treatment)

    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

  4. Probing of depth baseline

    Time frame: baseline (before treatment)

    Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe

  5. Biochemical outcomes baseline

    Time frame: baseline (before treatment)

    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 outcomes

  1. Clinical attachment level after 8 weeks

    Time frame: 8 weeks after treatment

    Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe

  2. Plaque index after 8 weeks

    Time frame: 8 weeks after treatment

    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

  3. Gingival index after 8 weeks

    Time frame: 8 weeks after treatment

    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

  4. Probing of dept after 8 weeks

    Time frame: 8 weeks after treatment

    Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe

  5. Biochemical outcomes after 8 weeks

    Time frame: 8 weeks after treatment

    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

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Measurement of Oncostatin M, Leukemia Inhibitory Factor and Interleukin-11 Levels in Serum, Saliva, and Gingival Crevicular Fluid of Patients With Periodontal Disease

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 22, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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