- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05774925
Evaluation of Salivary Biomarker Levels of Individuals With Different Periodontal Diseases
April 12, 2023 updated by: Ece Ozer, Izmir Katip Celebi University
Assessment of Saliva Leucine Rich α-2 Glycoprotein1 (LRG1) And C Reactive Protein (CRP) Levels In Individuals With Different Periodontal Diseases
The aim of this study is; detection of leucine rich α-2 glycoprotein1 (LRG1), c-reactive protein (CRP) levels in saliva samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases.
Materials and methods: Samples of saliva were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20).
Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded.
Enzyme-linked immunosorbent assay (ELISA) was used to determine LRG and CRP levels in the biological samples.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Çiğli
-
İzmir, Çiğli, Turkey, 35640
- Izmir Katip Çelebi University Department of Periodontology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)
- At least twenty permanent teeth in the mouth
- Non-smoker
- No medication for continuous use
- Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
- Not in pregnancy or lactation period.
- For the periodontitis group that has not received periodontal treatment in the last 6 months
- For the periodontitis group; According to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss
- For the gingivitis group; According to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss
- For healthy group; According to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.
Exclusion Criteria:
- Any oral or systemic disease
- Regularly using a systemic medication
- During pregnancy or lactation
- Received periodontal treatment within the last 6 months.
- Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
- Smokers are not included in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Periodontium
Full-mouth clinical periodontal measurements recorded and saliva obtained.
|
The patient was asked to sit upright and tilt his/her head forward to collect saliva samples.
İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth.
The accumulated saliva was collected in a sterile container.
It was then transferred to a propylene tube.
The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube.
Tubes were stored at -80ºC until the day of analysis.
|
Experimental: Gingivitis
Full-mouth clinical periodontal measurements recorded and saliva obtained.
|
The patient was asked to sit upright and tilt his/her head forward to collect saliva samples.
İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth.
The accumulated saliva was collected in a sterile container.
It was then transferred to a propylene tube.
The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube.
Tubes were stored at -80ºC until the day of analysis.
|
Experimental: Periodontitis
Full-mouth clinical periodontal measurements recorded and saliva obtained.
|
The patient was asked to sit upright and tilt his/her head forward to collect saliva samples.
İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth.
The accumulated saliva was collected in a sterile container.
It was then transferred to a propylene tube.
The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube.
Tubes were stored at -80ºC until the day of analysis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The total amount of LRG1 in saliva
Time Frame: 24 hours after taking the clinical measurements at the first visit
|
The total amount of leucine rich α-2 glycoprotein1 in saliva
|
24 hours after taking the clinical measurements at the first visit
|
The total amount of CRP in saliva
Time Frame: 24 hours after taking the clinical measurements at the first visit
|
The total amount of C-reactive protein in saliva
|
24 hours after taking the clinical measurements at the first visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mehmet Sağlam, Izmir Katip Celebi University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 8, 2021
Primary Completion (Actual)
March 20, 2023
Study Completion (Actual)
April 10, 2023
Study Registration Dates
First Submitted
March 7, 2023
First Submitted That Met QC Criteria
March 7, 2023
First Posted (Actual)
March 20, 2023
Study Record Updates
Last Update Posted (Estimate)
April 13, 2023
Last Update Submitted That Met QC Criteria
April 12, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-TDU-DİŞF-0016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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