NCT04647123

Brief Summary

The aim of this study was to compare IMA, MDA, CAT, GSH and ADA levels in gingival crevicular fluid, serum and saliva of periodontally hopeless, periodontitis and gingivitis teeth with healthy control groups.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

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

January 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

1.1 years

First QC Date

November 17, 2020

Last Update Submit

November 21, 2020

Conditions

Keywords

periodontitiscatalasemalondialdehide

Outcome Measures

Primary Outcomes (5)

  • adenosine deaminase

    Adenosine deaminase (ADA) is an enzyme involved in proliferation and differentiation. Although ADA has been investigated in different inflammatory and infectious diseases and has been defined as an immunoenzyme biomarker, its role in periodontitis has not been fully elucidated yet.

    1 year

  • catalase

    Catalase (CAT) decomposes H2O2 catalyzed by superoxide dismutase (SOD) into H2O and O2. (13) It is stated in the literature that CAT, SOD and total oxidant state are important biomarkers that can be used in the diagnosis of periodontal disease and evaluation of treatment results. (14)

    1 year

  • Ischemia-modified albumin

    Ischemia-modified albumin (IMA) is suggested as an oxidative stress marker and an indicator of inflammatory diseases. It has been reported in the literature that the serum IMA level increases significantly in the case of periodontal disease and decreases after treatment. In this respect, it has been stated that IMA can be an indicator of systemic inflammation caused by periodontal disease.

    1 year

  • malondialdehide

    In periodontal disease, an increase in reactive oxygen species and a decrease in antioxidant activity are observed because this disease is thought to be associated with an imbalance between antioxidants and oxidants. (8) Lipid peroxidation is a result of periodontitis. Free radicals that lead to the production of toxic and reactive aldehyde metabolites such as malondialdehyde (MDA) cause lipid peroxidation. (9) It is among the information in the literature that MDA levels increase in the case of periodontal inflammation and that MDA can be considered as an oxidative stress marker for periodontitis. (10-12)

    1 year

  • glutathione

    Glutathione (GSH) acts as a coenzyme in the oxidation-reduction process. (15) GSH is a critical redox regulator and important for the health of peridontium

    1 year

Study Arms (4)

Hopeless teeth

The teeth that can not be treated periodontally and who are desperate for extraction will be included in this group.

Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)

Periodontitis

Teeth diagnosed with periodontitis will be included in this group.

Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)

Gingivitis

Teeth diagnosed with gingivitis will be included in this group.

Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)

Healthy

Teeth diagnosed with helthy will be included in this group.

Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)

Interventions

No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)

GingivitisHealthyHopeless teethPeriodontitis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Systemically healhty ,non-smokers,non-pregnants will be included in the study

You may qualify if:

  • Systemically healhty non-smokers non-pregnants -

You may not qualify if:

  • \- Patients with systemic disease smokers pregnants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van yuzuncu yil university

Van, 65080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • hacer sahin aydınyurtt, assoc. prof

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hacer sahin aydınyurt

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
15 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

November 17, 2020

First Posted

November 30, 2020

Study Start

January 1, 2020

Primary Completion

February 1, 2021

Study Completion

March 1, 2021

Last Updated

November 30, 2020

Record last verified: 2020-11

Locations