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

Measurement of Oncostatin M, Leukemia Inhibitory Factor and Interleukin-11 Levels in Serum, Saliva, and Gingival Crevicular Fluid 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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Chronic Periodontitis, Generalized
• Intervention / Treatment: Procedure: Initial Periodontal Therapy

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 56 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Healthy; 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).
EXPERIMENTAL: Gingivitis; had varying degrees of gingival inflammation (GI≥1), PD≤3mm with no clinical attachment loss or with no alveolar bone destruction.	Procedure: Initial Periodontal Therapy; 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
EXPERIMENTAL: Chronic Periodontitis; 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.	Procedure: Initial Periodontal Therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline (before treatment)
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	baseline (before treatment)
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	baseline (before treatment)
Probing of depth baseline	Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe	baseline (before treatment)
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	baseline (before treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks after treatment
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	8 weeks after treatment
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	8 weeks after treatment
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	8 weeks after treatment
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	8 weeks after treatment

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2014
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (ACTUAL): October 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Gingivitis; Periodontal Therapy; Chronic Periodontitis; Gingival Crevicular Fluid; Interleukin-11; Oncostatin M; Leukemia Inhibitory Factor
• Additional Relevant MeSH Terms: Infections; Neoplasms by Histologic Type; Neoplasms; Stomatognathic Diseases; Mouth Diseases; Gingival Diseases; Periodontitis; Leukemia; Gingivitis; Periodontal Diseases; Chronic Periodontitis
• Other Study ID Numbers: OncosM,LIF,IL-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No