PeriodontitisNCT06354504
Bactericidal Permeability Protein Inhibitor and Interleukin-1beta Levels After Non-surgical Periodontal Treatment
A study testing Non-surgical periodontal treatment in people with Periodontitis, run by Akdeniz University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the relationship between healing response after non-surgical periodontal treatment and baseline gingival crevicular fluid (GCF) levels of bactericidal/permeability-increasing protein (BPI) and interleukin-1beta (IL-1ß). Read more about this study
- Who is it for?
- Ages 22 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- 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
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 19 Nov 2019to 20 Sep 2020
- 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 22 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy,
- Stage II or III, Grade A periodontitis
- Having at least 20 permanent teeth (excluding third molars and any tooth loss induced by -non-periodontal causes).
Who cannot join
- Smoking,
- use of alcohol; pregnancy or lactation; intake ofantibiotics, steroidal or non-steroidal anti-inflammatory drugs within the last 6 months
- having received periodontal treatment within the last 6 months
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Akdeniz Üniversity
Antalya, 07070
Akdeniz Üniversitesi Diş Hekimliği Fakültesi
Antalya
About this study
Official title: Gingival Crevicular Fluid (GCF) Bactericidal/Permeability-increasing Protein (BPI) and Interleukin (IL)-1beta in Periodontitis Patients: Non-surgical Periodontal Treatment Effects
The aim of this study was to examine the relationship between healing response after non-surgical periodontal treatment and baseline gingival crevicular fluid (GCF) levels of bactericidal/permeability-increasing protein (BPI) and interleukin-1beta (IL-1ß).
Read the detailed description
Bactericidal/permeability-increasing proteins (BPI) specific and powerful effect against Gram negative bacteria and their LPSs is completely observable in biological fluids such as plasma, serum, and whole blood.
Objective: It is the evaluation of periodontal disease effect of BPI and interleukin-1 beta (IL-1 β) levels in gingival fluid before and after non-surgical periodontal treatment (NSPT)in patients with periodontal disease.
Method: Thirty systemically healthy and non-smoking individuals with periodontitis were included in the study. Before NSPT, the clinical parameters of plaque index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAS), bleeding on probing (BOP) were measured. The gingival fluid samples were taken using the paper strip method. The same procedures were repeated at 6 weeks and 6 months after non-surgical periodontal treatment. ELISA method was used for the analysis of the samples
- Conditions
- Periodontitis
- Being tested
- Non-surgical periodontal treatment
- Medical subject headings
- Periodontitis
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
Scaling and root planing in two sessions over the course of a 48-hour period comprised the standard treatment procedure
| Study group | Role | What they receive |
|---|---|---|
| Healty | Experimental | Non-surgical periodontal treatment Receives: Procedure: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival crevicular fluid Bactericidal/permeability-increasing proteins levels
Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis patients after Non-surgical periodontal treatment
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Gingival crevicular fluid interleukin-1Beta levels
Gingival Crevicular Fluid IL-1β in periodonitis patients after Non-surgical periodontal treatment
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 posted9 Apr 2024
- Study start19 Nov 2019
- Primary completion20 Sep 2020
- Study completion20 Sep 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT06354504
- Sponsor's protocol ID
- 20.02.2019/177
- Status last verified
- Apr 2024
- First submitted
- 7 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid (GCF) Bactericidal/Permeability-increasing Protein (BPI) and Interleukin (IL)-1beta in Periodontitis Patients: Non-surgical Periodontal Treatment Effects
- ClinicalTrials.gov ID
- NCT06354504
- Acronym / sponsor ID
- 20.02.2019/177
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 9 Apr 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.
The aim of this study was to examine the relationship between healing response after non-surgical periodontal treatment and baseline gingival crevicular fluid (GCF) levels of bactericidal/permeability-increasing protein (BPI) and interleukin-1beta (IL-1ß).
Detailed description
Bactericidal/permeability-increasing proteins (BPI) specific and powerful effect against Gram negative bacteria and their LPSs is completely observable in biological fluids such as plasma, serum, and whole blood.
Objective: It is the evaluation of periodontal disease effect of BPI and interleukin-1 beta (IL-1 β) levels in gingival fluid before and after non-surgical periodontal treatment (NSPT)in patients with periodontal disease.
Method: Thirty systemically healthy and non-smoking individuals with periodontitis were included in the study. Before NSPT, the clinical parameters of plaque index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAS), bleeding on probing (BOP) were measured. The gingival fluid samples were taken using the paper strip method. The same procedures were repeated at 6 weeks and 6 months after non-surgical periodontal treatment. ELISA method was used for the analysis of the samples
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healty | Experimental | Procedure: Non-surgical periodontal treatmentNon-surgical periodontal treatment |
Who may qualify
- Ages
- 22 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Systemically healthy,
- Stage II or III, Grade A periodontitis
- Having at least 20 permanent teeth (excluding third molars and any tooth loss induced by -non-periodontal causes).
Key exclusion criteria (3 listed)
- Smoking,
- use of alcohol; pregnancy or lactation; intake ofantibiotics, steroidal or non-steroidal anti-inflammatory drugs within the last 6 months
- having received periodontal treatment within 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 |
|---|---|---|
| Non-surgical periodontal treatmentScaling and root planing in two sessions over the course of a 48-hour period comprised the standard treatment procedure | Procedure or surgery | Healty |
Primary outcome
Gingival crevicular fluid Bactericidal/permeability-increasing proteins levels
Time frame: through study completion, an average of 1 year
Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis patients after Non-surgical periodontal treatment
1 secondary outcome
Gingival crevicular fluid interleukin-1Beta levels
Time frame: through study completion, an average of 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 9 Apr 2024.
- Individual participant dataSharing planned: No
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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.
2 sites 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 Periodontitis, run by Akdeniz University at 2 sites 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 3 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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 proteins levels (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 9 Apr 2024.