PeriodontitisNCT06175624
Effect of Non-Surgical Periodontal Treatment on Gingival Crevicular Fluid and Serum Biomarker Levels
A study testing Clinically Helathy, Gingivitis and Periodontitis in people with Periodontitis and Gingivitis, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Periodontal diseases are one of the most common inflammatory diseases. Periodontitis results from products and antigens of microorganisms, which stimulates the innate immune system and local inflammatory response; characterized by gingival inflammation, attachment loss, and alveolar bone destruction. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis, Healthy
- What is being tested?
- Clinically Helathy, Gingivitis and Periodontitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Jul 2024
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Periodontal healthy group
- Stage III Grade B Periodontitis Group
- To meet the above-mentioned periodontal health and disease criteria
Who cannot join
- Periodontal tissues, periodontal disease course, periodontal application training and to have,
- Chronic alcohol and cigarette use,
- Oral contraceptive use, pregnancy, pregnant,
- Use of antibiotics or anti-inflammatory drugs within the last 6 months,
- Having undergone periodontal treatment in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Biruni Üniversity
Istanbul, Zeytinburnu, 34025
About this study
Periodontal diseases are one of the most common inflammatory diseases. Periodontitis results from products and antigens of microorganisms, which stimulates the innate immune system and local inflammatory response; characterized by gingival inflammation, attachment loss, and alveolar bone destruction. Molecules that play a role in the pathogenesis of periodontal disease can be used as biomarkers in the early diagnosis of periodontitis, in determining the rate of periodontal destruction, and in evaluating the response to periodontal treatment.
CTRPs (C1q/TNF-related proteins), which are adiponectin paralogs, are involved in inflammation, lipid, and glucose metabolism, as well as physiological and pathological processes like vasodilation. CTRP-1 is a glycoprotein belonging to the CTRP family that can be detected in serum in the presence of certain antibodies. Serum CTRP-1 levels increase in type 2 diabetes, prediabetes, coronary artery diseases, congestive heart failure, and atherosclerosis. Lipopolysaccharides found in Gram-negative bacteria cell walls stimulate the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α and interleukin (IL)-1 β, as well as indirectly increasing the production of CTRP-1. CTRP-1 is a therapeutic target in many inflammatory diseases, including periodontal diseases. However, there are no clinical studies on the role of CTRP-1 in the pathogenesis of periodontal disease. Based on these findings, the goal of our research is to examine the effects of periodontal disease on CTRP-1, IL-10, and TNF-α levels in serum and gingival crevicular fluid samples taken before and after periodontal treatment from periodontally healthy individuals and individuals with gingivitis and periodontitis, and also determine whether CTRP-1 is a potential biomarker that can be used in the diagnosis of periodontal disease.
25 patients with periodontitis, 25 with gingivitis and 25 healthy periodontals (total of 75 individuals) will be included in our study. At the beginning of the study, periodontal clinical measurements (gingival index, plaque index, probing depth, gingival recession, clinical attachment level, and bleeding on probing), serum and gingival crevicular fluid samples will be taken from all individuals. Non-surgical periodontal treatment will be applied in quadrant wise within 2 weeks to individuals with gingivitis and periodontitis. 12 weeks after treatment; the clinical measurements and the collection of serum and gingival crevicular fluid will be repeated. Biomarkers in serum and gingival crevicular fluid samples will be examined by ELISA.
- Conditions
- Periodontitis, Gingivitis, Healthy
- Being tested
- Clinically Helathy, Gingivitis, Periodontitis
- Keywords
- Periodontitis, Periodontal Therapy, Biomarker
- Medical subject headings
- Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinically HelathyOther
Our study will include 25 people with clinically healthy patients.
Gingival crevicular fluid and serum will be collected during the clinical measurements Biomarkers in serum and gingival crevicular fluid samples will be examined by ELISA.
CTRP-1 levels will be examined to evaluate the effects of periodontal treatment in periodontal health, gingivitis and periodontitis.
Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and sample will be taken from all individuals at the beginning of the study.
GingivitisOther
Our study will include 25 people with gingivitis patients.
Gingival crevicular fluid and serum will be collected during the clinical measurements Biomarkers in serum and gingival crevicular fluid samples will be examined by ELISA.
CTRP-1 levels will be examined to evaluate the effects of periodontal treatment in periodontal health, gingivitis and periodontitis.
Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and sample will be taken from all individuals at the beginning of the study.
PeriodontitisOther
Our study will include 25 people with periodontitis patients.
Non-surgical periodontal treatment will be applied to individuals with periodontitis, serum and gingival crevicular fluid samples will be collected before the treatment, clinical measurements and gingival crevicular fluid and serum collection will be repeated 12 weeks after the treatment. CTRP-1 analysis will be performed by ELISA.
CTRP-1 levels will be examined to evaluate the effects of periodontal treatment in periodontal health, gingivitis and periodontitis.
Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Healthy | Active comparator | Our study will include 25 people with clinically healthy patients. Receives: Other: Clinically Helathy |
| Gingivitis | Experimental | Our study will include 25 people with gingivitis patients. Receives: Other: Gingivitis |
| Periodontitis | Experimental | Our study will include 25 people with periodontitis patients. Receives: Other: Periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination of CTRP-1 levels of periodontal disease and clinically healthy
Examination of CTRP-1 levels, which are stated to be associated with periodontal disease, in gingival crevicular fluid and serum samples obtained from individuals with periodontitis.
Measured: up to 1 year
Evaluation of the effect of non-surgical periodontal treatment on changes in CTRP-1 level.
Evaluation of the effect of non-surgical periodontal treatment on changes in CTRP-1 level.
Measured: up to 1 year
Comparison biomarkers of study groups.
Comparison of gingival crevicular fluid and serum samples taken before treatment in individuals with periodontitis in terms of CTRP-1 levels.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Dec 2023
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 25 patients with periodontitis, 25 with gingivitis and 25 healthy periodontals (total of 75 individuals) will be included in our study. At the beginning of the study, periodontal clinical measurements (gingival index, plaque index, probing depth, gingival recession, clinical attachment level, and bleeding on probing), serum and gingival crevicular fluid samples will be taken from all individuals. Non-surgical periodontal treatment will be applied in quadrant wise within 2 weeks to individuals with gingivitis and periodontitis. 12 weeks after treatment; the clinical measurements and the collection of serum and gingival crevicular fluid will be repeated. Biomarkers in serum and gingival crevicular fluid samples will be examined by ELISA.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu KARADUMAN, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175624
- Sponsor's protocol ID
- 2015-KAEK-79-23-07
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Surgical Periodontal Treatment on Gingival Crevicular Fluid and Serum Biomarker Levels
- ClinicalTrials.gov ID
- NCT06175624
- Acronym / sponsor ID
- 2015-KAEK-79-23-07
- Conditions
- Periodontitis, Gingivitis, Healthy
- Keywords
- Periodontitis, Periodontal Therapy, Biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 19 Dec 2023 (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.
Periodontal diseases are one of the most common inflammatory diseases. Periodontitis results from products and antigens of microorganisms, which stimulates the innate immune system and local inflammatory response; characterized by gingival inflammation, attachment loss, and alveolar bone destruction. Molecules that play a role in the pathogenesis of periodontal disease can be used as biomarkers in the early diagnosis of periodontitis, in determining the rate of periodontal destruction, and in evaluating the response to periodontal treatment.
CTRPs (C1q/TNF-related proteins), which are adiponectin paralogs, are involved in inflammation, lipid, and glucose metabolism, as well as physiological and pathological processes like vasodilation. CTRP-1 is a glycoprotein belonging to the CTRP family that can be detected in serum in the presence of certain antibodies. Serum CTRP-1 levels increase in type 2 diabetes, prediabetes, coronary artery diseases, congestive heart failure, and atherosclerosis. Lipopolysaccharides found in Gram-negative bacteria cell walls stimulate the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α and interleukin (IL)-1 β, as well as indirectly increasing the production of CTRP-1. CTRP-1 is a therapeutic target in many inflammatory diseases, including periodontal diseases. However, there are no clinical studies on the role of CTRP-1 in the pathogenesis of periodontal disease. Based on these findings, the goal of our research is to examine the effects of periodontal disease on CTRP-1, IL-10, and TNF-α levels in serum and gingival crevicular fluid samples taken before and after periodontal treatment from periodontally healthy individuals and individuals with gingivitis and periodontitis, and also determine whether CTRP-1 is a potential biomarker that can be used in the diagnosis of periodontal disease.
25 patients with periodontitis, 25 with gingivitis and 25 healthy periodontals (total of 75 individuals) will be included in our study. At the beginning of the study, periodontal clinical measurements (gingival index, plaque index, probing depth, gingival recession, clinical attachment level, and bleeding on probing), serum and gingival crevicular fluid samples will be taken from all individuals. Non-surgical periodontal treatment will be applied in quadrant wise within 2 weeks to individuals with gingivitis and periodontitis. 12 weeks after treatment; the clinical measurements and the collection of serum and gingival crevicular fluid will be repeated. Biomarkers in serum and gingival crevicular fluid samples will be examined by ELISA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- 25 patients with periodontitis, 25 with gingivitis and 25 healthy periodontals (total of 75 individuals) will be included in our study. At the beginning of the study, periodontal clinical measurements (gingival index, plaque index, probing depth, gingival recession, clinical attachment level, and bleeding on probing), serum and gingival crevicular fluid samples will be taken from all individuals. Non-surgical periodontal treatment will be applied in quadrant wise within 2 weeks to individuals with gingivitis and periodontitis. 12 weeks after treatment; the clinical measurements and the collection of serum and gingival crevicular fluid will be repeated. Biomarkers in serum and gingival crevicular fluid samples will be examined by ELISA.
| Arm | Type | Receives |
|---|---|---|
| Clinical Healthy | Active comparator | Other: Clinically HelathyOur study will include 25 people with clinically healthy patients. |
| Gingivitis | Experimental | Other: GingivitisOur study will include 25 people with gingivitis patients. |
| Periodontitis | Experimental | Other: PeriodontitisOur study will include 25 people with periodontitis patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Periodontal healthy group
- Stage III Grade B Periodontitis Group
- To meet the above-mentioned periodontal health and disease criteria
Key exclusion criteria (5 listed)
- Periodontal tissues, periodontal disease course, periodontal application training and to have,
- Chronic alcohol and cigarette use,
- Oral contraceptive use, pregnancy, pregnant,
- Use of antibiotics or anti-inflammatory drugs within the last 6 months,
- Having undergone periodontal treatment in the last 6 months.
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 |
|---|---|---|
| Clinically HelathyOur study will include 25 people with clinically healthy patients. Gingival crevicular fluid and serum will be collected during the clinical measurements Biomarkers in serum and gingival crevicular fluid samples will be examined by ELISA. CTRP-1 levels will be examined to evaluate the effects of periodontal treatment in periodontal health, gingivitis and periodontitis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and sample will be taken from all individuals at the beginning of the study. | Other | Clinical Healthy |
| GingivitisOur study will include 25 people with gingivitis patients. Gingival crevicular fluid and serum will be collected during the clinical measurements Biomarkers in serum and gingival crevicular fluid samples will be examined by ELISA. CTRP-1 levels will be examined to evaluate the effects of periodontal treatment in periodontal health, gingivitis and periodontitis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and sample will be taken from all individuals at the beginning of the study. | Other | Gingivitis |
| PeriodontitisOur study will include 25 people with periodontitis patients. Non-surgical periodontal treatment will be applied to individuals with periodontitis, serum and gingival crevicular fluid samples will be collected before the treatment, clinical measurements and gingival crevicular fluid and serum collection will be repeated 12 weeks after the treatment. CTRP-1 analysis will be performed by ELISA. CTRP-1 levels will be examined to evaluate the effects of periodontal treatment in periodontal health, gingivitis and periodontitis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study. | Other | Periodontitis |
Primary outcome
Examination of CTRP-1 levels of periodontal disease and clinically healthy
Time frame: up to 1 year
Examination of CTRP-1 levels, which are stated to be associated with periodontal disease, in gingival crevicular fluid and serum samples obtained from individuals with periodontitis.
Evaluation of the effect of non-surgical periodontal treatment on changes in CTRP-1 level.
Time frame: up to 1 year
Evaluation of the effect of non-surgical periodontal treatment on changes in CTRP-1 level.
Comparison biomarkers of study groups.
Time frame: up to 1 year
Comparison of gingival crevicular fluid and serum samples taken before treatment in individuals with periodontitis in terms of CTRP-1 levels.
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 22 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Clinically Helathy, Gingivitis and Periodontitis in people with Periodontitis and Gingivitis, run by Biruni 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 3 inclusion and 5 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 22 Jun 2025. 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?
Examination of CTRP-1 levels of periodontal disease and clinically healthy (time frame: up to 1 year). 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 22 Jun 2025.