Periodontal Health Status in Patients with Systemic Sclerosis

NCT ID: NCT05215431

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-05

Study Completion Date

2024-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Sclerosis Periodontitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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systemic sclerosis group

Patients with established diagnoses of systemic sclerosis and periodontitis

Group Type EXPERIMENTAL

periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis

Intervention Type PROCEDURE

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.

Activity of antioxidants in unstimulated saliva (GPX, SOD, UA)

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits .

Periodontal treatment

Intervention Type PROCEDURE

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.

periodontitis group

Systemically healthy periodontitis patients

Group Type EXPERIMENTAL

periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis

Intervention Type PROCEDURE

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.

Activity of antioxidants in unstimulated saliva (GPX, SOD, UA)

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid were determined using commercial ELISA (enzyme-linked immunosorbent assay) kits .

Periodontal treatment

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type 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 .

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Belgrade

OTHER

Sponsor Role lead

Responsible Party

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Natasa Nikolic Jakoba

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Natasa Nikolic Jakoba, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Dental Medicine, University of Belgrade, Serbia

Locations

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Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade

Belgrade, , Serbia

Site Status RECRUITING

Countries

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Serbia

Central Contacts

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Natasa Nikolic Jakoba, DDS, PhD

Role: CONTACT

+381112685288

Facility Contacts

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Stefan Sredojevic

Role: primary

+381113317988

Other Identifiers

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Unique Protocol ID: UBelgrade7

Identifier Type: -

Identifier Source: org_study_id

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