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

Gingivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597073
• Other study ID #: OncosM,LIF,IL-11
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: August 2014

Study information

• Verified date: October 2020
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 56 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Chronic Periodontitis, Generalized
• Gingivitis
• Leukemia
• Periodontal Diseases
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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