PeriodontitisPhase 1NCT02632981
IL-32 Levels in Patients With Chronic Periodontitis
A Phase 1 study testing nonsurgical periodontal treatment and Gingival crevicular fluid and saliva collection in people with Periodontitis, run by Bulent Ecevit University.
Trial summary
Interleukin-32 (IL-32) is a recently described cytokine that is a strong inducer of pro-inflammatory cytokines such as tumor necrosis factor (TNF)-α. A previous report have reported that Porphyromonas gingivalis-derived LPS significantly up-regulated IL-32 expression compared with the unstimulated cells in monocytes… Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- nonsurgical periodontal treatment and Gingival crevicular fluid and saliva collection
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jul 2015
- Phase
- Phase 1
- 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 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- all subjects in the study were possess of at least 20 teeth excluding third molars.
Who cannot join
- agressive periodontitis,
- periapical pathologies,
- excessive forces including mechanical forces caused by orthodontic forces and occlusal forces;
- presence of systemic diseases;
- administration of non-steroidal and anti-inflammatory drugs or antibiotic therapies within the previous 6 months;
- need for antibiotic prophylaxis for dental treatment and having received non-surgical periodontal treatment within the past 6 months or surgical periodontal treatment within the past 12 months;
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- allergy or sensitivity to any drug,
- pregnancy,
- lactation, and
- current and former use of tobacco.
About this study
Official title: IL-32 Levels in Gingival Crevicular Fluid and Saliva of Patients With Chronic Periodontitis After Periodontal Treatment.
Interleukin-32 (IL-32) is a recently described cytokine that is a strong inducer of pro-inflammatory cytokines such as tumor necrosis factor (TNF)-α. A previous report have reported that Porphyromonas gingivalis-derived LPS significantly up-regulated IL-32 expression compared with the unstimulated cells in monocytes (THP-1 cells). They suggested that IL-32 may contribute to the pathogenesis of periodontal disease. In the present study the investigators hypothesized that IL-32 levels may increase in the gingival crevicular fluid (GCF) and saliva of patients with chronic periodontitis compared with healthy controls and these levels may decrease together with treatment.
Read the detailed description
The purpose of this study was to investigate IL-32 levels in the GCF and saliva of patients with chronic periodontitis and to evaluate changes after nonsurgical periodontal therapy.
Twenty-seven CP and 27 periodontally healthy controls were enrolled in this study. Periodontitis patients received nonsurgical periodontal treatment. GCF and saliva sampling and clinical periodontal parameters were assessed before and a month after treatment. IL-32, IL-10 and TNF-α levels in GCF and saliva were measured by enzyme-linked immunosorbent assay.
Unstimulated salivary samples were collected using standard techniques. About 2 mL whole saliva was collected in disposable tubes and centrifuged immediately to remove cell debris (10,000 g x 10 minutes). The supernatants (50µL each) were stored at -40C until analyzed. GCF samples were collected from a mesio-buccal and disto-palatal site on each tooth. In the CP group, the samples were obtained from patients at areas with ≥5 mm CAL, ≥6 mm PD and ≥30% bone loss. In the healthy group, GCF samples were collected from teeth exhibiting PD<3 mm without CAL and BOP. The area was isolated with cotton rolls, saliva contamination elimination was ensured, and it was slightly air dried. GCF was sampled with paper strips. Paper strips were placed into the crevice until mild resistance was felt (intracrevicular method) and left in the position for 30 seconds. Strips contaminated with blood or saliva were discarded. Each sampled strip was placed into a 400µl eppendorf centrifuge tube and stored at -40C until analyzed.
- Conditions
- Periodontitis
- Being tested
- nonsurgical periodontal treatment, Gingival crevicular fluid and saliva collection
- Keywords
- Interleukin-32, periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonsurgical periodontal treatmentOther
Also called chronic periodontitis patients
Scaling and root planning under local anaesthesia, in a total of four clinical visits Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.
Gingival crevicular fluid and saliva collectionOther
Also called periodontally healthy controls, chronic periodontitis patients
GCF collection with filter paper (Periopaper) using the intracrevicular method. Patients' mouths were rinsed with distilled water, and unstimulated salivary samples were collected by patients expectorating into disposable tubes.
| Study group | Role | What they receive |
|---|---|---|
| chronic periodontitis patients | Active comparator | gingival crevicular fluid and saliva collecion were taken before and after nonsurgical periodontal treatment Receives: Other: nonsurgical periodontal treatment |
| periodontally healthy controls | Placebo comparator | gingival crevicular fluid and saliva collection were taken at baseline after oral hygiene instructions Receives: Other: Gingival crevicular fluid and saliva collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical parameters (IL-32, IL-10 and THF-alpha)
The changes in levels of IL-32 after periodontal treatment determined by ELISA. The changes in levels of IL-32 were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontitis.
Measured: Baseline and 1 month after treatment
Secondary outcomes (5)
Probing pocket depth
The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.
Measured: Baseline and 1 month after treatment
Probing pocket depth and clinical attachment level
The changes in clinical attachment level after periodontal treatment. The probing depth and the distance from the gingival margin to the cemento-enamel junction are used to measurement of clinical attachment level. Clinical attachment level was measured for determining severity of disease and clinic outcome.
Measured: Baseline and 1 month after treatment
Gingival index
The changes in gingival index after periodontal treatment. Gingival index was recorded for classifying and evaluating (coronally) gingival inflammation.
Measured: Baseline and 1 month after treatment
Plaque index
The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.
Measured: Baseline and 1 month after treatment
Bleeding on probing
The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.
Measured: Baseline and 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionJul 2015
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.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Figen ÖNGÖZ DEDE, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632981
- Sponsor's protocol ID
- 2014-10-14-01
- Status last verified
- Dec 2015
- First submitted
- 10 Dec 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IL-32 Levels in Gingival Crevicular Fluid and Saliva of Patients With Chronic Periodontitis After Periodontal Treatment.
- ClinicalTrials.gov ID
- NCT02632981
- Acronym / sponsor ID
- 2014-10-14-01
- Conditions
- Periodontitis
- Keywords
- Interleukin-32, periodontitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Dec 2015 (estimated)
- 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.
Interleukin-32 (IL-32) is a recently described cytokine that is a strong inducer of pro-inflammatory cytokines such as tumor necrosis factor (TNF)-α. A previous report have reported that Porphyromonas gingivalis-derived LPS significantly up-regulated IL-32 expression compared with the unstimulated cells in monocytes (THP-1 cells). They suggested that IL-32 may contribute to the pathogenesis of periodontal disease. In the present study the investigators hypothesized that IL-32 levels may increase in the gingival crevicular fluid (GCF) and saliva of patients with chronic periodontitis compared with healthy controls and these levels may decrease together with treatment.
Detailed description
The purpose of this study was to investigate IL-32 levels in the GCF and saliva of patients with chronic periodontitis and to evaluate changes after nonsurgical periodontal therapy.
Twenty-seven CP and 27 periodontally healthy controls were enrolled in this study. Periodontitis patients received nonsurgical periodontal treatment. GCF and saliva sampling and clinical periodontal parameters were assessed before and a month after treatment. IL-32, IL-10 and TNF-α levels in GCF and saliva were measured by enzyme-linked immunosorbent assay.
Unstimulated salivary samples were collected using standard techniques. About 2 mL whole saliva was collected in disposable tubes and centrifuged immediately to remove cell debris (10,000 g x 10 minutes). The supernatants (50µL each) were stored at -40C until analyzed. GCF samples were collected from a mesio-buccal and disto-palatal site on each tooth. In the CP group, the samples were obtained from patients at areas with ≥5 mm CAL, ≥6 mm PD and ≥30% bone loss. In the healthy group, GCF samples were collected from teeth exhibiting PD<3 mm without CAL and BOP. The area was isolated with cotton rolls, saliva contamination elimination was ensured, and it was slightly air dried. GCF was sampled with paper strips. Paper strips were placed into the crevice until mild resistance was felt (intracrevicular method) and left in the position for 30 seconds. Strips contaminated with blood or saliva were discarded. Each sampled strip was placed into a 400µl eppendorf centrifuge tube and stored at -40C until analyzed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic periodontitis patients | Active comparator | Other: nonsurgical periodontal treatmentgingival crevicular fluid and saliva collecion were taken before and after nonsurgical periodontal treatment |
| periodontally healthy controls | Placebo comparator | Other: Gingival crevicular fluid and saliva collectiongingival crevicular fluid and saliva collection were taken at baseline after oral hygiene instructions |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all subjects in the study were possess of at least 20 teeth excluding third molars.
Key exclusion criteria (10 listed)
- agressive periodontitis,
- periapical pathologies,
- excessive forces including mechanical forces caused by orthodontic forces and occlusal forces;
- presence of systemic diseases;
- administration of non-steroidal and anti-inflammatory drugs or antibiotic therapies within the previous 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 |
|---|---|---|
| nonsurgical periodontal treatmentAlso: chronic periodontitis patientsScaling and root planning under local anaesthesia, in a total of four clinical visits Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush. | Other | chronic periodontitis patients |
| Gingival crevicular fluid and saliva collectionAlso: periodontally healthy controls, chronic periodontitis patientsGCF collection with filter paper (Periopaper) using the intracrevicular method. Patients' mouths were rinsed with distilled water, and unstimulated salivary samples were collected by patients expectorating into disposable tubes. | Other | periodontally healthy controls |
Primary outcome
Biochemical parameters (IL-32, IL-10 and THF-alpha)
Time frame: Baseline and 1 month after treatment
The changes in levels of IL-32 after periodontal treatment determined by ELISA. The changes in levels of IL-32 were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontitis.
5 secondary outcomes
Probing pocket depth
Time frame: Baseline and 1 month after treatment
Probing pocket depth and clinical attachment level
Time frame: Baseline and 1 month after treatment
Gingival index
Time frame: Baseline and 1 month after treatment
Plaque index
Time frame: Baseline and 1 month after treatment
Bleeding on probing
Time frame: Baseline and 1 month after treatment
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 Dec 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing nonsurgical periodontal treatment and Gingival crevicular fluid and saliva collection in people with Periodontitis, run by Bulent Ecevit University.
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 10 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Biochemical parameters (IL-32, IL-10 and THF-alpha) (time frame: Baseline and 1 month after treatment). 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 Dec 2015.