HealthyNCT06178081
Effect of Non-Surgical Periodontal Treatment on Biomarker Levels
A study testing Periodontal Healthy in people with Healthy and Periodontitis, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis is a destructive disease that follows untreated gingivitis and is characterized by gingival inflammation, clinical attachment loss, alveolar bone loss and periodontal pocket formation, increased tooth mobility and tooth loss. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Periodontitis
- What is being tested?
- Periodontal Healthy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 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 and C Periodontitis Group
- To meet the above-mentioned periodontal health and disease criteria
Who cannot join
- Chronic alcohol use,
- Oral contraceptive use, pregnancy, pregnant,
- Last 6 months antibiotic or anti-inflammatory drug use,
- To have periodontal therapy in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Non-Surgical Periodontal Treatment on Biomarker Levels in Smoker and Non-Smoker Periodontitis Patients
Periodontitis is a destructive disease that follows untreated gingivitis and is characterized by gingival inflammation, clinical attachment loss, alveolar bone loss and periodontal pocket formation, increased tooth mobility and tooth loss. Although the primary etiological factor is microbial dental plaque, the host response plays an important role in the transition from periodontal health to disease. Smoking is a major risk factor for periodontitis and affects the formation and severity of the disease and healing after periodontal treatment by changing the host response to plaque. Proinflammatory and antiinflammatory cytokines have an important role in the pathogenesis of periodontal disease. Among these cytokines, interleukin (IL)-1β, IL-10 and currently IL-39 have been associated with periodontal disease. Further studies with post-treatment longitudinal evaluation are needed to elucidate the functions of IL-39 and its possible role in the pathogenesis of periodontal diseases. In this study, it was aimed to investigate the effects of non-surgical periodontal treatment on salivary and gingival crevicular fluid (GCF) IL-39, IL-1β and IL-10 levels in smokers and non-smokers with Stage 3 Grade B periodontitis and periodontally healthy individuals, both smokers and non-smokers. To the best of our knowledge, there is no study investigating the effects of non-surgical periodontal treatment and smoking on IL-39.
50 individuals with periodontitis and 50 periodontally healthy individuals (total 100 individuals) will be included in our study, and these two groups will be divided into two sub-groups as smokers and non-smokers. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing), saliva and GCF samples will be taken from all individuals at the beginning of the study. Non-surgical periodontal treatment will be performed in individuals with periodontitis. Saliva and GCF samples will be collected before treatment. The clinical measurements, saliva and GCF collection will be repeated 12 weeks after the treatment. The saliva and GCF levels of IL-39, IL-1β and IL-10 will be analyzed by ELISA. Cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis.
With this study, we aimed to develop IL-39 diagnostic kits for the diagnosis of periodontal diseases, detection of disease activity, follow-up of response to treatment and healing.
- Conditions
- Healthy, Periodontitis
- Being tested
- Periodontal Healthy
- Keywords
- periodontal therapy, biomarker, periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal HealthyOther
Also called Periodontitis
Non surgical periodontal therapy
| Study group | Role | What they receive |
|---|---|---|
| Clinical Healthy | Active comparator | Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and gingival crevicular fluid will be taken from all individuals at the beginning of the study. IL-39 and cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and gingival crevicular fluid will be collected from the clinically healthy group. Receives: Other: Periodontal Healthy |
| Periodontitis | Experimental | Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and gingival crevicular fluid will be repeated 12 weeks after the treatment. IL-39 analysis will be performed by ELISA in saliva and gingival crevicular fluid of individuals. IL-39 and cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health 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. Receives: Other: Periodontal Healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination of IL-39 levels of periodontal disease and clinically healthy
Examination of IL-39 levels, which are stated to be associated with periodontal disease, in gingival crevicular fluid and saliva samples obtained from individuals with periodontitis.
Measured: up to 1 year
Secondary outcomes (1)
Evaluation of the effect of non-surgical periodontal treatment on changes in IL-39 level.
Evaluation of the effect of non-surgical periodontal treatment on changes in IL-39 level.
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 posted20 Dec 2023
- Study start1 Jan 2024
- 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 HealthyStudies 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
- Our study will include 50 people with periodontitis and 50 healthy periodontal patients (100 individuals in total), and these two groups will be divided into two as smokers and non-smokers. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and gingival cerevicular fluid will be taken from all individuals at the beginning of the study. Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and gingival crevicular fluid will be repeated 12 weeks after the treatment. IL-39 analysis will be performed by ELISA in saliva and gingival crevicular fluid of individuals. IL-39 and cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 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
- NCT06178081
- Sponsor's protocol ID
- 2015-KAEK-79-23-08
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 25 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Surgical Periodontal Treatment on Biomarker Levels in Smoker and Non-Smoker Periodontitis Patients
- ClinicalTrials.gov ID
- NCT06178081
- Acronym / sponsor ID
- 2015-KAEK-79-23-08
- Conditions
- Healthy, Periodontitis
- Keywords
- periodontal therapy, biomarker, periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 20 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.
Periodontitis is a destructive disease that follows untreated gingivitis and is characterized by gingival inflammation, clinical attachment loss, alveolar bone loss and periodontal pocket formation, increased tooth mobility and tooth loss. Although the primary etiological factor is microbial dental plaque, the host response plays an important role in the transition from periodontal health to disease. Smoking is a major risk factor for periodontitis and affects the formation and severity of the disease and healing after periodontal treatment by changing the host response to plaque. Proinflammatory and antiinflammatory cytokines have an important role in the pathogenesis of periodontal disease. Among these cytokines, interleukin (IL)-1β, IL-10 and currently IL-39 have been associated with periodontal disease. Further studies with post-treatment longitudinal evaluation are needed to elucidate the functions of IL-39 and its possible role in the pathogenesis of periodontal diseases. In this study, it was aimed to investigate the effects of non-surgical periodontal treatment on salivary and gingival crevicular fluid (GCF) IL-39, IL-1β and IL-10 levels in smokers and non-smokers with Stage 3 Grade B periodontitis and periodontally healthy individuals, both smokers and non-smokers. To the best of our knowledge, there is no study investigating the effects of non-surgical periodontal treatment and smoking on IL-39.
50 individuals with periodontitis and 50 periodontally healthy individuals (total 100 individuals) will be included in our study, and these two groups will be divided into two sub-groups as smokers and non-smokers. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing), saliva and GCF samples will be taken from all individuals at the beginning of the study. Non-surgical periodontal treatment will be performed in individuals with periodontitis. Saliva and GCF samples will be collected before treatment. The clinical measurements, saliva and GCF collection will be repeated 12 weeks after the treatment. The saliva and GCF levels of IL-39, IL-1β and IL-10 will be analyzed by ELISA. Cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis.
With this study, we aimed to develop IL-39 diagnostic kits for the diagnosis of periodontal diseases, detection of disease activity, follow-up of response to treatment and healing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Our study will include 50 people with periodontitis and 50 healthy periodontal patients (100 individuals in total), and these two groups will be divided into two as smokers and non-smokers. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and gingival cerevicular fluid will be taken from all individuals at the beginning of the study. Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and gingival crevicular fluid will be repeated 12 weeks after the treatment. IL-39 analysis will be performed by ELISA in saliva and gingival crevicular fluid of individuals. IL-39 and cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis.
| Arm | Type | Receives |
|---|---|---|
| Clinical Healthy | Active comparator | Other: Periodontal HealthyClinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and gingival crevicular fluid will be taken from all individuals at the beginning of the study. IL-39 and cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and gingival crevicular fluid will be collected from the clinically healthy group. |
| Periodontitis | Experimental | Other: Periodontal HealthyNon-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and gingival crevicular fluid will be repeated 12 weeks after the treatment. IL-39 analysis will be performed by ELISA in saliva and gingival crevicular fluid of individuals. IL-39 and cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health 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. |
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 and C Periodontitis Group
- To meet the above-mentioned periodontal health and disease criteria
Key exclusion criteria (4 listed)
- Chronic alcohol use,
- Oral contraceptive use, pregnancy, pregnant,
- Last 6 months antibiotic or anti-inflammatory drug use,
- To have periodontal therapy 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 |
|---|---|---|
| Periodontal HealthyAlso: PeriodontitisNon surgical periodontal therapy | Other | Clinical Healthy, Periodontitis |
Primary outcome
Examination of IL-39 levels of periodontal disease and clinically healthy
Time frame: up to 1 year
Examination of IL-39 levels, which are stated to be associated with periodontal disease, in gingival crevicular fluid and saliva samples obtained from individuals with periodontitis.
1 secondary outcome
Evaluation of the effect of non-surgical periodontal treatment on changes in IL-39 level.
Time frame: up to 1 year
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 25 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 Periodontal Healthy in people with Healthy and Periodontitis, 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 4 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 25 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 IL-39 levels of periodontal disease and clinically healthy (time frame: up to 1 year). 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 25 Jun 2025.