Periodontal Health Status in Patients with Systemic Sclerosis

The EFFECTS of NON-SURGICAL PERIODONTAL TREATMENT in PATIENTS with SYSTEMIC SCLEROSIS

The aim of the research will be to evaluate the effects of NSPT on clinical periodontal parameters, level of antioxidants in unstimulated saliva and the levels of biomarkers (VEGF, TGF-β, IL-17) in the GCF in SSc patients in comparison with systemically healthy controls. Twenty systemic sclerosis patients with periodontitis (SS group) and twenty systemically healthy periodontitis patients (P group) will be enrolled in the present study. The results may indicate higher periodontal destruction and antioxidant perturbations in unstimulated saliva of systemic sclerosis patients with periodontitis compared to systemically healthy periodontitis patients.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Systemic Sclerosis
• Intervention / Treatment: Procedure: periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis; Diagnostic test: Activity of antioxidants in unstimulated saliva (GPX, SOD, UA); Diagnostic test: Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid; Procedure: Periodontal treatment

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natasa Nikolic Jakoba, DDS, PhD; Phone Number: +381112685288; Email: natasa.nikolic.jakoba@stomf.bg.ac.rs

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade
    • Contact: Stefan Sredojevic; Phone Number: +381113317988; Email: sredojevic43@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Patients with established diagnoses of systemic sclerosis according to the American Rheumatism Association criteria for scleroderma were referred from the Institut for rheumatology, Belgrade, Serbia to the Department of Periodontology, School of Dental Medicine, University of Belgrade, Serbia for screening.

After the exclusion of patients who did not meet the inclusion criteria or declined to participate, 2O systemic sclerosis patients with periodontitis were enrolled in the present study.

Twenty systemically healthy patients with periodontitis who were seeking care at the Department of Periodontology, School of Dental Medicine, University of Belgrade, Serbia were recruited in the control group.

Description

Inclusion Criteria:

• established diagnoses of systemic sclerosis and periodontitis (study group),
• age ≥ 18
• presence of minimum 12 teeth

Exclusion Criteria:

• concurrent inflammatory mediated rheumatic diseases
• pregnancy or lactation
• active cigarette smokers
• a history of periodontal, antibiotics or non-steroidal drug therapy in the past 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: systemic sclerosis group; Patients with established diagnoses of systemic sclerosis and periodontitis	Procedure: periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis; Periodontal parameters has been recorded on six sites of each tooth using a manual periodontal probe. Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) has been determined using the colorimetric method and commercial kits. Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits . The therapeutic procedure begun with ultrasonic scaling (MiniPiezon, EMS Electro Medical Systems, Switzerland), along with education and motivation of subjects to maintain oral hygiene properly. Periodontal debridement was carried out under local anesthesia, by quadrants, starting from the upper right quadrant at 7-day intervals until the completion of therapy. Instrumentation of all periodontal pockets was processed manually using specialized curettes.; Diagnostic test: Activity of antioxidants in unstimulated saliva (GPX, SOD, UA); Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) has been determined using the colorimetric method and commercial kits.; Diagnostic test: Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid; Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits .; Procedure: Periodontal treatment; The therapeutic procedure begun with ultrasonic scaling (MiniPiezon, EMS Electro Medical Systems, Switzerland), along with education and motivation of subjects to maintain oral hygiene properly. Periodontal debridement was carried out under local anesthesia, by quadrants, starting from the upper right quadrant at 7-day intervals until the completion of therapy. Instrumentation of all periodontal pockets was processed manually using specialized curettes.
Experimental: periodontitis group; Systemically healthy periodontitis patients	Procedure: periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis; Periodontal parameters has been recorded on six sites of each tooth using a manual periodontal probe. Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) has been determined using the colorimetric method and commercial kits. Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits . The therapeutic procedure begun with ultrasonic scaling (MiniPiezon, EMS Electro Medical Systems, Switzerland), along with education and motivation of subjects to maintain oral hygiene properly. Periodontal debridement was carried out under local anesthesia, by quadrants, starting from the upper right quadrant at 7-day intervals until the completion of therapy. Instrumentation of all periodontal pockets was processed manually using specialized curettes.; Diagnostic test: Activity of antioxidants in unstimulated saliva (GPX, SOD, UA); Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) has been determined using the colorimetric method and commercial kits.; Diagnostic test: Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid; Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits .; Procedure: Periodontal treatment; The therapeutic procedure begun with ultrasonic scaling (MiniPiezon, EMS Electro Medical Systems, Switzerland), along with education and motivation of subjects to maintain oral hygiene properly. Periodontal debridement was carried out under local anesthesia, by quadrants, starting from the upper right quadrant at 7-day intervals until the completion of therapy. Instrumentation of all periodontal pockets was processed manually using specialized curettes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level (CAL)	Measuring the CAL by periodontal probe, measured in mm	one day
Probing depth (PD)	Measuring the PD by periodontal probe, measured in mm	one day
Gingival margin level (GML)	Measuring the GML by periodontal probe, measured in mm	one day
The degree of gingival inflammation	The degree of gingival inflammation was assessed using the Loe and Silness (LSGI) gingival index.	one day
plaque index (PI)	Evaluation of oral hygiene status was recorded with a Silness Loe plaque index (PI).	one day
The concentration of vascular endothelial growth factor (VEGF)	The level of VEGF were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits.	baseline and two months after periodontal treatment
The concentration of transforming growth factor beta (TGF-β)	The level of TGF-β in gingival crevicular fluid was determined using commercial ELISA (enzyme-linked immunosorbent assay) kits at the Implant Research Center, School of Dental Medicine, University of Belgrade, following the manufacturer's instructions.	baseline and two months after periodontal treatment
The concentration of interleukin (IL)-17	interleukin (IL)-17 was determined using commercial ELISA (enzyme-linked immunosorbent assay) kits at the Implant Research Center, School of Dental Medicine, University of Belgrade, following the manufacturer's instructions.	baseline and two months after periodontal treatment
The concentration of glutathion peroxidase (GPX)	Activity level of GPX, determined using the colorimetric method and commercial kits.	one day
The concentration of uric acid (UA)	Activity level of UA, determined using the colorimetric method and commercial kits.	one day
The concentration of superoxide dismutase (SOD)	Activity level of SOD, determined using the colorimetric method and commercial kits.	one day
The concentration of tumor necrosis factor alpha		baseline and two months after periodontal treatment
The concentration of C reactive protein		baseline and two months after periodontal treatment
Erythrocyte sedimentation rate (ESR)		baseline and two months after periodontal treatment

Collaborators and Investigators

• Sponsor: University of Belgrade
• Investigators: Principal Investigator: Natasa Nikolic Jakoba, DDS, PhD, School of Dental Medicine, University of Belgrade, Serbia

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2019
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: periodontitis; antioxidants; systemic sclerosis; saliva
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Sclerosis; Periodontitis; Scleroderma, Systemic; Scleroderma, Diffuse; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: Unique Protocol ID: UBelgrade7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No