PeriodontitisNCT06295666
Gingival Crevicular Fluid (GCF) Bactericidal Permeability Protein (BPI) and Interleukin (IL)-1 Beta
An observational study of Periodontitis and Gingival Crevicular Fluid, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study is to determine the amounts of BPI (Bactericidal permeability protein) and interleukin-1beta (IL-1β) in gingival fluid samples obtained from individuals with periodontally healthy and periodontal disease, to compare these amounts between study groups, and to evaluate their relationship… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingival Crevicular Fluid, Interleukin 1-beta
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2019to 20 Jan 2020
- 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: Patients who applied to Akdeniz University Faculty of Dentistry Department of Periodontology between 19/02/2019 and 25/11/2019 were included.
Who may be able to join
- For the periodontitis group, intraoral examination shows inflammation in the gums, supragingival and by observing the formation of subgingival tartar and microbial dental plaque and pockets, Diagnosis of periodontitis means that there is a vertical or detection of horizontal bone loss (Periodontitis group),
- Failure to observe the presence of periodontal pockets, vertical and horizontal no bone destruction, bleeding score on full-mouth probing below 10 percent (Healthy group),
- Agreeing to participate in the research and filling out and signing the voluntary consent form.
Who cannot join
- Pregnant and lactating individuals,
- Individuals who smoke,
- Individuals with any systemic disease,
- Individuals who have received periodontal treatment in the last 6 months,
- Individuals who have used antibiotics in the last 6 months
- Individuals in whom local factors that increase destruction such as fillings and crowns are observed in areas with periodontal pocket formation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz Üniversitesi Diş Hekimliği Fakültesi
Antalya
About this study
Official title: Gingival Crevicular Fluid(GCF) Bactericidal Permeability Protein (BPI) and Interleukin(IL)-1 Beta Levels and Relationship With Periodontal Disease
Objective: The aim of this study is to determine the amounts of BPI (Bactericidal permeability protein) and interleukin-1beta (IL-1β) in gingival fluid samples obtained from individuals with periodontally healthy and periodontal disease, to compare these amounts between study groups, and to evaluate their relationship with clinical parameters. In cases where clinical parameters increase, IL-1β amounts also increase significantly. The amount of IL-1β in individuals with periodontal disease is significantly higher compared to healthy individuals. There is positive correlation between BPI and clinical parameters. The amount of BPI in individuals with periodontal disease is significantly higher than in healthy individuals. More studies are needed to better understand the importance and therapeutic effect of BPI in periodontitis
Read the detailed description
Systemically healthy and non-smoking participants were included in the study. The study groups included a total of 100 participants, 50 of whom were periodontally healthy (healthy group) and 50 with periodontal disease (periodontitis) group). The clinical parameters of plaque index (PI), gingival index (GI), and pocket depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP) were measured.
The gingival fluid samples were taken in the direction of the paper strip and ELISA method was used for their analysis. A positive, statistically significant relationship was found between IL-1β levels and all clinical parameters (PI, GI, PD, CAL, BOP) (p<0,01). Likewise, there is a positive and significant relationship between BPI levels and clinical parameters (p<0,01).
There is a statistically significant positive correlation between GCF volume and clinical parameters PI (r: 0,722), GI (r: 0,740), PD (r: 0,742), CAL (r: 0,751) and BOP (r: 0.752) (p < 0.01). In the comparison between the groups, it is seen that both IL-1β and BPI levels were statistically significantly higher in the periodontitis group compared to the healthy group (p < 0,001).
- Conditions
- Periodontitis, Gingival Crevicular Fluid, Interleukin 1-beta, Bactericidal Permeability Protein
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healty | Periodontal healty group | |
| Periodontitis | Periodontitis group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis
Protein levels that increase gingival crevicular fluid bactericidal permeability are expected to increase in the periodontitis group.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start19 Feb 2019
- Primary completion25 Nov 2019
- Study completion20 Jan 2020
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 Akdeniz 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezahat Arzu Kayar, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295666
- Sponsor's protocol ID
- 26.12.2018/901
- Status last verified
- Mar 2024
- First submitted
- 2 Jan 2024
- Last updated
- 6 Mar 2024
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid(GCF) Bactericidal Permeability Protein (BPI) and Interleukin(IL)-1 Beta Levels and Relationship With Periodontal Disease
- ClinicalTrials.gov ID
- NCT06295666
- Acronym / sponsor ID
- 26.12.2018/901
- Conditions
- Periodontitis, Gingival Crevicular Fluid, Interleukin 1-beta, Bactericidal Permeability Protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 6 Mar 2024 (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.
Objective: The aim of this study is to determine the amounts of BPI (Bactericidal permeability protein) and interleukin-1beta (IL-1β) in gingival fluid samples obtained from individuals with periodontally healthy and periodontal disease, to compare these amounts between study groups, and to evaluate their relationship with clinical parameters. In cases where clinical parameters increase, IL-1β amounts also increase significantly. The amount of IL-1β in individuals with periodontal disease is significantly higher compared to healthy individuals. There is positive correlation between BPI and clinical parameters. The amount of BPI in individuals with periodontal disease is significantly higher than in healthy individuals. More studies are needed to better understand the importance and therapeutic effect of BPI in periodontitis
Detailed description
Systemically healthy and non-smoking participants were included in the study. The study groups included a total of 100 participants, 50 of whom were periodontally healthy (healthy group) and 50 with periodontal disease (periodontitis) group). The clinical parameters of plaque index (PI), gingival index (GI), and pocket depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP) were measured.
The gingival fluid samples were taken in the direction of the paper strip and ELISA method was used for their analysis. A positive, statistically significant relationship was found between IL-1β levels and all clinical parameters (PI, GI, PD, CAL, BOP) (p<0,01). Likewise, there is a positive and significant relationship between BPI levels and clinical parameters (p<0,01).
There is a statistically significant positive correlation between GCF volume and clinical parameters PI (r: 0,722), GI (r: 0,740), PD (r: 0,742), CAL (r: 0,751) and BOP (r: 0.752) (p < 0.01). In the comparison between the groups, it is seen that both IL-1β and BPI levels were statistically significantly higher in the periodontitis group compared to the healthy group (p < 0,001).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healty | – | –Periodontal healty group |
| Periodontitis | – | –Periodontitis group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who applied to Akdeniz University Faculty of Dentistry Department of Periodontology between 19/02/2019 and 25/11/2019 were included.
Key inclusion criteria (3 listed)
- For the periodontitis group, intraoral examination shows inflammation in the gums, supragingival and by observing the formation of subgingival tartar and microbial dental plaque and pockets, Diagnosis of periodontitis means that there is a vertical or detection of horizontal bone loss (Periodontitis group),
- Failure to observe the presence of periodontal pockets, vertical and horizontal no bone destruction, bleeding score on full-mouth probing below 10 percent (Healthy group),
- Agreeing to participate in the research and filling out and signing the voluntary consent form.
Key exclusion criteria (6 listed)
- Pregnant and lactating individuals,
- Individuals who smoke,
- Individuals with any systemic disease,
- Individuals who have received periodontal treatment in the last 6 months,
- Individuals who have used antibiotics 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.
Primary outcome
Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis
Time frame: through study completion, an average of 1 year
Protein levels that increase gingival crevicular fluid bactericidal permeability are expected to increase in the periodontitis group.
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 6 Mar 2024.
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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 Periodontitis and Gingival Crevicular Fluid, run by Akdeniz 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 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 6 Mar 2024. 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?
Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis (time frame: through study completion, an average of 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 6 Mar 2024.