Periodontal InflammationNCT03345745
Saliva Levels of S100A12, CRP, Fetuin-A in Periodontal Disease Patients
An observational study of Periodontal Inflammation, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontal Inflammation
- What is being tested?
- salivary samples
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 1 Sep 2017
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Short-Term Effects of Non-Surgical Periodontal Therapy on The Saliva Levels of S100A12, High-Sensitivity C-Reactive Protein and Fetuin-A in Patients With Gingivitis and Chronic Periodontitis
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.
- Conditions
- Periodontal Inflammation
- Being tested
- salivary samples
- Keywords
- Fetuin-A, S100A12, C-Reactive Protein, Chronic Periodontitis
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Periodontally healthy subjects | Salivary samples Receives: Diagnostic Test: salivary samples | |
| Chronic periodontitis patients | Salivary samples Receives: Diagnostic Test: salivary samples | |
| Gingivitis patients | Salivary samples Receives: Diagnostic Test: salivary samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary acute phase proteins
Fetuin-A
Measured: Baseline - a month after the periodontal treatments
Salivary acute phase proteins
S100A12
Measured: Baseline - a month after the periodontal treatments
Salivary acute phase proteins
C-Reactive Protein
Measured: Baseline
Secondary outcomes (5)
Evaluating periodontal health
plaque index
Measured: Baseline - a month after the periodontal treatments
Evaluating periodontal health
gingival index
Measured: Baseline - a month after the periodontal treatments
Evaluating periodontal health
probing depth
Measured: Baseline
Evaluating periodontal health
clinical attachment level
Measured: Baseline - a month after the periodontal treatments
Evaluating periodontal health
gingival bleeding on probing
Measured: Baseline - a month after the periodontal treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Feb 2017
- Primary completion1 Jun 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cankat Kara, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345745
- Sponsor's protocol ID
- OrduUniversityDentistry
- Status last verified
- Nov 2017
- First submitted
- 13 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short-Term Effects of Non-Surgical Periodontal Therapy on The Saliva Levels of S100A12, High-Sensitivity C-Reactive Protein and Fetuin-A in Patients With Gingivitis and Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03345745
- Acronym / sponsor ID
- OrduUniversityDentistry
- Conditions
- Periodontal Inflammation
- Keywords
- Fetuin-A, S100A12, C-Reactive Protein, Chronic Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontally healthy subjects | – | Diagnostic Test: salivary samplesSalivary samples |
| Chronic periodontitis patients | – | Diagnostic Test: salivary samplesSalivary samples |
| Gingivitis patients | – | Diagnostic Test: salivary samplesSalivary samples |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salivary samplesSalivary Hs-CRP, Fetuin-A and S100A12 levels and salivary flow rates were evaluated at baseline and a month after the treatments | Diagnostic test | Chronic periodontitis patients, Gingivitis patients, Periodontally healthy subjects |
Primary outcome
Salivary acute phase proteins
Time frame: Baseline - a month after the periodontal treatments
Fetuin-A
Salivary acute phase proteins
Time frame: Baseline - a month after the periodontal treatments
S100A12
Salivary acute phase proteins
Time frame: Baseline
C-Reactive Protein
5 secondary outcomes
Evaluating periodontal health
Time frame: Baseline - a month after the periodontal treatments
Evaluating periodontal health
Time frame: Baseline - a month after the periodontal treatments
Evaluating periodontal health
Time frame: Baseline
Evaluating periodontal health
Time frame: Baseline - a month after the periodontal treatments
Evaluating periodontal health
Time frame: Baseline - a month after the periodontal treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Inflammation, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary acute phase proteins (time frame: Baseline - a month after the periodontal treatments). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.