NCT05215431

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

November 1, 2023

Enrollment Period

5.7 years

First QC Date

January 18, 2022

Last Update Submit

September 16, 2024

Conditions

Systemic SclerosisPeriodontitis

Keywords

systemic sclerosisperiodontitisantioxidantssaliva

Outcome Measures

Primary Outcomes (14)

  • 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

Study Arms (2)

systemic sclerosis group

EXPERIMENTAL

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 periodontitisDiagnostic Test: Activity of antioxidants in unstimulated saliva (GPX, SOD, UA)Diagnostic Test: Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluidProcedure: Periodontal treatment

periodontitis group

EXPERIMENTAL

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 periodontitisDiagnostic Test: Activity of antioxidants in unstimulated saliva (GPX, SOD, UA)Diagnostic Test: Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluidProcedure: Periodontal treatment

Interventions

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

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.

periodontitis groupsystemic sclerosis group
Activity of antioxidants in unstimulated saliva (GPX, SOD, UA)DIAGNOSTIC_TEST

Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) has been determined using the colorimetric method and commercial kits.

periodontitis groupsystemic sclerosis group
Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluidDIAGNOSTIC_TEST

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

periodontitis groupsystemic sclerosis group
Periodontal treatmentPROCEDURE

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 groupsystemic sclerosis group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Belgrade, 11000, Serbia

RECRUITING

MeSH Terms

Conditions

Scleroderma, SystemicPeriodontitis

Interventions

Vascular Endothelial Growth Factor AInterleukin-17Periodontal Index

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Vascular Endothelial Growth FactorsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsInterleukinsCytokinesDental Health SurveysHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDentistryPeriodonticsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Dentistry

Study Officials

  • Natasa Nikolic Jakoba, DDS, PhD

    School of Dental Medicine, University of Belgrade, Serbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasa Nikolic Jakoba, DDS, PhD

CONTACT

+381112685288natasa.nikolic.jakoba@stomf.bg.ac.rs

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 31, 2022

Study Start

February 5, 2019

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

September 19, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)