GingivitisNCT04390997
Determination of the Levels of Lipocalin-2 and Semaphorin3A
A study testing Non-surgical Periodontal Treatment in people with Gingivitis and Periodontitis, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial is to investigate the concentrations of Lipocalin-2 and Semaphorin 3A levels in gingival crevicular fluid in subjects with different periodontal diseases. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Periodontitis, Periodontal Diseases
- What is being tested?
- Non-surgical Periodontal Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2019to 15 Jan 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being systemically healthy
- Having at least 20 teeth in the dentition, excluding third molars
- Not using alcohol nor smoking
- Not using medications
- Not taking any antibiotics, anti-inflammatory, nor systemic corticosteroid drugs in the last six months
- Not being in the lactation period nor pregnancy
Who cannot join
- Having any oral or systemic diseases
- Using alcohol or smoking
- Using medications
- Taking any antibiotics, anti-inflammatory, or systemic corticosteroid drugs in the last six months
- Being in the lactation period or pregnancy
- Being treated with periodontal treatment in the last six months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Celebi University, Faculty of Dentistry
Izmir, Cigli, 35640
About this study
Official title: Determination of the Levels of Lipocalin-2 and Semaphorin3A in Gingival Crevicular Fluid in Subjects With Different Periodontal Diseases
The aim of this clinical trial is to investigate the concentrations of Lipocalin-2 and Semaphorin 3A levels in gingival crevicular fluid in subjects with different periodontal diseases. At the same time for the periodontitis group; the purpose of this study is to analyze the correlation of these proteins with clinical parameters at the first and third months after the nonsurgical periodontal treatment.
Read the detailed description
In our study, gingival crevicular fluid samples will be taken along with the measurement of all oral clinical parameters from sixty systemically healthy volunteers (20 periodontally healthy, 20 gingivitis, and 20 periodontitis). Gingival crevicular fluid samples will be taken again after the nonsurgical periodontal treatment for the periodontitis group in the first and third months. Lipocalin-2 and Semaphorin 3A levels will be determined by an enzyme-linked immunosorbent assay test (ELISA). Subsequent statistical analyses will be used to interpret protein levels among different groups and peridontitis group after the nonsurgical periodontal treatment.
Possible significant differences may illuminate the future work with Lipocalin-2 and Semaphorin 3A. Also, these glycoproteins may help to develop different diagnostic methods or treatment strategies for future periodontal treatments.
- Conditions
- Gingivitis, Periodontitis, Periodontal Diseases
- Being tested
- Non-surgical Periodontal Treatment
- Keywords
- Periodontal Disease, Non-surgical Periodontal Treatment, GCF
- Medical subject headings
- Gingivitis, Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical Periodontal TreatmentProcedure or surgery
Non-surgical periodontal treatment includes scaling and root planning by using curettes and ultrasonic devices only in the periodontitis group.
| Study group | Role | What they receive |
|---|---|---|
| Periodontally Healthy | No intervention | 20 participants with bleeding on probing less than 10%, probing depths less than 4mm, and no clinical attachment loss which was measured by six sites per tooth |
| Gingivitis | No intervention | 20 participants with bleeding on probing greater than 10%, probing depths less than 4mm, and no clinical attachment loss which was measured by six sites per tooth |
| Periodontitis | Other | 20 participants with bleeding on probing greater than or equal to 30%, probing depths greater than or equal to 5mm at least non-adjacent two teeth in each quadrant of the dentition, and clinical attachment loss greater than or equal to 4mm which was measured by six sites per tooth, and radiographic bone loss on the coronal third of root or severe (vertical/ horizontal) bone loss. Receives: Procedure: Non-surgical Periodontal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of Lipocalin-2
Investigating the concentrations of Lipocalin-2 level in gingival crevicular fluid in subjects with different periodontal diseases.
Measured: 18 months
The level of Semaphorin 3A
Investigating the concentrations of Semaphorin 3A leves in gingival crevicular fluid in subjects with different periodontal diseases.
Measured: 18 months
Secondary outcomes (1)
Effects of non-surgical periodontal treatment on the levels of Lipocalin-2 and Semaphorin3A
Analyzing the correlation of Lipocalin-2 and Semaphorin3A with clinical parameters at the first and third months after the nonsurgical periodontal treatment
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start15 Nov 2019
- Primary completion15 Dec 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Ceylan, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390997
- Sponsor's protocol ID
- 2019-TDU-DİSF-0009
- Status last verified
- Feb 2021
- First submitted
- 13 May 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Levels of Lipocalin-2 and Semaphorin3A in Gingival Crevicular Fluid in Subjects With Different Periodontal Diseases
- ClinicalTrials.gov ID
- NCT04390997
- Acronym / sponsor ID
- 2019-TDU-DİSF-0009
- Conditions
- Gingivitis, Periodontitis, Periodontal Diseases
- Keywords
- Periodontal Disease, Non-surgical Periodontal Treatment, GCF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 18 May 2020 (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.
The aim of this clinical trial is to investigate the concentrations of Lipocalin-2 and Semaphorin 3A levels in gingival crevicular fluid in subjects with different periodontal diseases. At the same time for the periodontitis group; the purpose of this study is to analyze the correlation of these proteins with clinical parameters at the first and third months after the nonsurgical periodontal treatment.
Detailed description
In our study, gingival crevicular fluid samples will be taken along with the measurement of all oral clinical parameters from sixty systemically healthy volunteers (20 periodontally healthy, 20 gingivitis, and 20 periodontitis). Gingival crevicular fluid samples will be taken again after the nonsurgical periodontal treatment for the periodontitis group in the first and third months. Lipocalin-2 and Semaphorin 3A levels will be determined by an enzyme-linked immunosorbent assay test (ELISA). Subsequent statistical analyses will be used to interpret protein levels among different groups and peridontitis group after the nonsurgical periodontal treatment.
Possible significant differences may illuminate the future work with Lipocalin-2 and Semaphorin 3A. Also, these glycoproteins may help to develop different diagnostic methods or treatment strategies for future periodontal treatments.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy | No intervention | –20 participants with bleeding on probing less than 10%, probing depths less than 4mm, and no clinical attachment loss which was measured by six sites per tooth |
| Gingivitis | No intervention | –20 participants with bleeding on probing greater than 10%, probing depths less than 4mm, and no clinical attachment loss which was measured by six sites per tooth |
| Periodontitis | Other | Procedure: Non-surgical Periodontal Treatment20 participants with bleeding on probing greater than or equal to 30%, probing depths greater than or equal to 5mm at least non-adjacent two teeth in each quadrant of the dentition, and clinical attachment loss greater than or equal to 4mm which was measured by six sites per tooth, and radiographic bone loss on the coronal third of root or severe (vertical/ horizontal) bone loss. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being systemically healthy
- Having at least 20 teeth in the dentition, excluding third molars
- Not using alcohol nor smoking
- Not using medications
- Not taking any antibiotics, anti-inflammatory, nor systemic corticosteroid drugs in the last six months
Key exclusion criteria (6 listed)
- Having any oral or systemic diseases
- Using alcohol or smoking
- Using medications
- Taking any antibiotics, anti-inflammatory, or systemic corticosteroid drugs in the last six months
- Being in the lactation period or pregnancy
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 |
|---|---|---|
| Non-surgical Periodontal TreatmentNon-surgical periodontal treatment includes scaling and root planning by using curettes and ultrasonic devices only in the periodontitis group. | Procedure or surgery | Periodontitis |
Primary outcome
The level of Lipocalin-2
Time frame: 18 months
Investigating the concentrations of Lipocalin-2 level in gingival crevicular fluid in subjects with different periodontal diseases.
The level of Semaphorin 3A
Time frame: 18 months
Investigating the concentrations of Semaphorin 3A leves in gingival crevicular fluid in subjects with different periodontal diseases.
1 secondary outcome
Effects of non-surgical periodontal treatment on the levels of Lipocalin-2 and Semaphorin3A
Time frame: 18 months
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 10 Feb 2021.
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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 Non-surgical Periodontal Treatment in people with Gingivitis and Periodontitis, run by Izmir Katip Celebi 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 6 inclusion and 6 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 10 Feb 2021. 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?
The level of Lipocalin-2 (time frame: 18 months). The study lists 2 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 10 Feb 2021.