NCT03345745

Brief Summary

Hs-CRP, Fetuin-A and S100A12 are acute phase proteins associated with many systemic diseases and conditions. The aim of this study was to determine the clinical parameters and salivary Hs-CRP, Fetuin-A and S100A12 levels before and after non-surgical periodontal treatments in the patients with periodontal diseases. A total of 54 subjects were divided in to three groups; periodontally healthy (n: 18), gingivitis (n: 18), chronic periodontitis (n: 18). Clinical periodontal parameters, salivary Hs-CRP, Fetuin-A and S100A12 levels and salivary flow rates were evaluated at baseline and a month after the treatments. Salivary Hs-CRP, Fetuin-A and S100A12 levels were assayed by ELISA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

4 months

First QC Date

November 13, 2017

Last Update Submit

November 16, 2017

Conditions

Periodontal Inflammation

Keywords

Fetuin-AS100A12C-Reactive ProteinChronic Periodontitis

Outcome Measures

Primary Outcomes (3)

  • Salivary acute phase proteins

    Fetuin-A

    Baseline - a month after the periodontal treatments

  • Salivary acute phase proteins

    S100A12

    Baseline - a month after the periodontal treatments

  • Salivary acute phase proteins

    C-Reactive Protein

    Baseline

Secondary Outcomes (5)

  • Evaluating periodontal health

    Baseline - a month after the periodontal treatments

  • Evaluating periodontal health

    Baseline - a month after the periodontal treatments

  • Evaluating periodontal health

    Baseline

  • Evaluating periodontal health

    Baseline - a month after the periodontal treatments

  • Evaluating periodontal health

    Baseline - a month after the periodontal treatments

Study Arms (3)

Periodontally healthy subjects

Salivary samples

Diagnostic Test: salivary samples

Chronic periodontitis patients

Salivary samples

Diagnostic Test: salivary samples

Gingivitis patients

Salivary samples

Diagnostic Test: salivary samples

Interventions

salivary samplesDIAGNOSTIC_TEST

Salivary Hs-CRP, Fetuin-A and S100A12 levels and salivary flow rates were evaluated at baseline and a month after the treatments

Chronic periodontitis patientsGingivitis patientsPeriodontally healthy subjects

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Fifty-four patients (27 women) aged 25-45 years who had presented to our faculty for periodontal and other dental problems and consented to participate were enrolled in the study. Group 1 - subjects with healthy periodontal status Group 2 - subjects with untreated gingivitis Group 3 - subjects with untreated chronic periodontitis (indicted by radiographic evidence of bone loss and clinical attachment loss \> 5 mm in more than six teeth)

You may qualify if:

  • never-smokers no history of systemic disease no patients had been under periodontal therapy and medicine for at least 6 months before the study no pregnancy or lactation no alcohol or antioxidant vitamin consumption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 17, 2017

Study Start

February 1, 2017

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

TU(1)