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

NCT04597073 | Completed

• 1 other identifier: OncosM,LIF,IL-11
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Periodontitis, Generalized; Gingivitis

Keywords

Chronic Periodontitis; Gingival Crevicular Fluid; Leukemia Inhibitory Factor; Oncostatin M; Interleukin-11; Periodontal Therapy; Gingivitis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Clinical attachment level after 8 weeks

  8 weeks after treatment

• Plaque index after 8 weeks

  8 weeks after treatment

• Gingival index after 8 weeks

  8 weeks after treatment

• Probing of dept after 8 weeks

  8 weeks after treatment

• Biochemical outcomes after 8 weeks

  8 weeks after treatment

Study Arms (3)

Healthy

NO INTERVENTION

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).

Gingivitis

EXPERIMENTAL

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

Chronic Periodontitis

EXPERIMENTAL

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

Interventions

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

Chronic Periodontitis; Gingivitis

Eligibility Criteria

• Age: 20 Years - 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• systemically healthy
• non-smokers

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

MeSH Terms

Conditions

Chronic Periodontitis; Gingivitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Gingival Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 22, 2020
• Study Start: March 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 22, 2020

Record last verified: 2020-10