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Trial registered on ANZCTR


Registration number
ACTRN12618001738213
Ethics application status
Approved
Date submitted
24/09/2018
Date registered
23/10/2018
Date last updated
30/01/2020
Date data sharing statement initially provided
1/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of IL-17 and IL-35 associations in saliva and gingival crevicular fluid in patients with periodontitis as smokers and non-smokers.
Scientific title
Evaluation of IL-17 and IL-35 associations in saliva and gingival crevicular fluid in patients with periodontitis as smokers and non-smokers
Secondary ID [1] 296149 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
periodontitis 309746 0
Condition category
Condition code
Oral and Gastrointestinal 308548 308548 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A total of 60 subjects will be grouped as: 20 non-smoker patients with periodontitis (Group 1), 20 smoker patients with periodontitis (Group 2), 20 non-smoker and periodontally healthy individuals who will refer to clinic of Gazi University Dentistry Faculty Periodontology Department for control. To determine the periodontal health status of each individual, Plaque Index (Silness and Leech, 1964), Gingival Index (Löe and Silness, 1963), Pocket Depth, Bleeding in Probing Index (Ainamo & Bay, 1976), Clinical Attachment Level will be measured and recorded. Systemic anamnesis will be taken and recorded in order to learn the general systemic status of the participants. In order to evaluate the patients in terms of periodontal disease, treatment history and individual oral hygiene applications, the latest dentist control, the last periodontal treatment history, the frequency of tooth brushing, the frequency of using the interface cleaning tools will be recorded. Smoking status (and the amount) of individuals who will participate in the study, will be determined by oral anamnesis. Spitting method will be used for collecting saliva samples; accordingly, the saliva will be allowed to accumulate in the base of the mouth, then individual will spit into the polypropylene tube every 60 seconds for 5 minutes. Tubes will be kept at -30 ° C until they are examined. The paper strip method will be used for gingival crevicular fluid (GCF) sample collection; samples will be taken from the mesial and distal surfaces of the teeth (healthy or have greater than or equal to 5mm pocket depth) after isolation from the saliva. Paper strips contaminated with saliva and blood will not be included in the study. Then the strips will be weighed and the amount of GCF will be calculated. Paper strips will be transferred to polypropylene tubes and stored at -30 ° C until inspection. ELISA kits will be used for the detection of saliva and GCF’s IL-17 and IL-35. The approximate length of involvement will be 40 minutes for each participants.
Intervention code [1] 312476 0
Early Detection / Screening
Intervention code [2] 312486 0
Diagnosis / Prognosis
Comparator / control treatment
20 individuals without periodontitis will be taken as a control group.
Control group
Active

Outcomes
Primary outcome [1] 307525 0
IL-17 levels in gingival crevicular fluid by ELISA
Timepoint [1] 307525 0
Baseline
Primary outcome [2] 307721 0
IL-17 levels in saliva by ELISA
Timepoint [2] 307721 0
Baseline
Secondary outcome [1] 352200 0
IL-35 levels in gingival crevicular fluid by ELISA
Timepoint [1] 352200 0
Baseline
Secondary outcome [2] 352637 0
IL-35 levels in saliva by ELISA
Timepoint [2] 352637 0
Baseline
Secondary outcome [3] 353149 0
Plaque Index by using Williams periodontal probe.
Timepoint [3] 353149 0
Baseline
Secondary outcome [4] 353150 0
Gingival Index by using Williams periodontal probe.
Timepoint [4] 353150 0
Baseline
Secondary outcome [5] 353151 0
Pocket Depth by using Williams periodontal probe.
Timepoint [5] 353151 0
Baseline
Secondary outcome [6] 353152 0
Bleeding in Probing Index by using Williams periodontal probe.
Timepoint [6] 353152 0
Baseline
Secondary outcome [7] 353153 0
Clinical Attachment Level by using Williams periodontal probe.
Timepoint [7] 353153 0
Baseline

Eligibility
Key inclusion criteria
To be volunteer to participate in the study
To be over 18
Being systemically healthy
Having greater than or equal to 15 teeth out of 3rd molar teeth
To have localized or generalized periodontitis for the experimental group (clinical attachment loss in at least 6 surrounding areas and presence of greater than or equal to 5 mm periodontal pocket)
For Smoking group; more than 10 cigarettes a day for more than 5 years
For non-smokers; have not smoked for at least 5 years.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have any systemic disease affecting periodontal condition
To receive periodontal treatment in the last 6 months
Use any medication that may affect the inflammatory process in the last 3 months
Use local or systemic antibiotics in the last 3 months
Pregnancy or lactation for female patients
Regular use of mouthwash

Study design
Purpose
Screening
Duration
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/10/2018
Actual
17/12/2018
Date of last participant enrolment
Anticipated
Actual
14/06/2019
Date of last data collection
Anticipated
20/03/2020
Actual
Sample size
Target
60
Accrual to date
Final
57
Recruitment outside Australia
Country [1] 20865 0
Turkey
State/province [1] 20865 0

Funding & Sponsors
Funding source category [1] 300736 0
Self funded/Unfunded
Name [1] 300736 0
Ezgi Sila TASKALDIRAN
Country [1] 300736 0
Turkey
Funding source category [2] 300749 0
Self funded/Unfunded
Name [2] 300749 0
Gülay TÜTER
Country [2] 300749 0
Turkey
Primary sponsor type
University
Name
Gazi University Scientific Research Projects
Address
Gazi University Main Campus, Bandirma Street, No: 6/1 06500 Yenimahalle / ANKARA
Country
Turkey
Secondary sponsor category [1] 300273 0
None
Name [1] 300273 0
None
Address [1] 300273 0
None
Country [1] 300273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301518 0
Gazi University Dentistry Faculty Ethics Committee of Clinical Research
Ethics committee address [1] 301518 0
Ethics committee country [1] 301518 0
Turkey
Date submitted for ethics approval [1] 301518 0
31/08/2018
Approval date [1] 301518 0
23/11/2018
Ethics approval number [1] 301518 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87262 0
Mrs Ezgi Sila TASKALDIRAN
Address 87262 0
Gazi University Dentistry Faculty Department of Periodontology, Biskek Street, 1st Street. No:4
06510
Ankara/Turkey
Country 87262 0
Turkey
Phone 87262 0
+905556312089
Fax 87262 0
Email 87262 0
ezgisilasoyluoglu@gmail.com
Contact person for public queries
Name 87263 0
Gülay TÜTER
Address 87263 0
Gazi University Dentistry Faculty Department of Periodontology, Biskek Street, 1st Street. No:4
06510
Ankara/Turkey
Country 87263 0
Turkey
Phone 87263 0
+903122034240
Fax 87263 0
Email 87263 0
gulay@gazi.edu.tr
Contact person for scientific queries
Name 87264 0
Ezgi Sila TASKALDIRAN
Address 87264 0
Gazi University Dentistry Faculty Department of Periodontology, Biskek Street, 1st Street. No:4
06510
Ankara/Turkey
Country 87264 0
Turkey
Phone 87264 0
+905556312089
Fax 87264 0
Email 87264 0
ezgisilasoyluoglu@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.