PeriodontitisNCT04053660
Effect Of Non-Surgical Periodontal Treatment On Lipoxin a4 Levels
A study testing Non-surgical periodontal treatment in people with Periodontitis, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the levels of lipoxin A4 (LXA4), prostaglandin E2 (PGE2) and leukotriene B4 (LTB4) in gingival crevicular fluid (GCF) and saliva in individuals with periodontal healthy and chronic periodontitis. Read more about this study
- Who is it for?
- Ages 25 to 65 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
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2017to 31 Dec 2018
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have at least 20 natural teeth, excluding third molars.
- Chronic periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm with gingival inflammation, and alveolar bone loss affecting >30% of the teeth, as detected on clinical and radiographical examinations.
- Periodontally healthy control group had no sign of gingival inflammation, no PD > 3mm and no evidence of attachment or bone loss.
Who cannot join
- History of systemic disease.
- Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.
- Periodontal treatment during last 6 months that could affect periodontal status.
- Smoking.
- History of radiotherapy or chemotherapy.
- Ongoing orthodontic treatment.
- Aggressive periodontitis.
- Current pregnancy, lactation or menopause.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Non-Surgical Periodontal Treatment On Endogenous Anti-Inflammatory Lipid Mediators In Patients With Chronic Periodontitis
The aim of this study was to evaluate the levels of lipoxin A4 (LXA4), prostaglandin E2 (PGE2) and leukotriene B4 (LTB4) in gingival crevicular fluid (GCF) and saliva in individuals with periodontal healthy and chronic periodontitis. In addition, the investigators evaluated the levels of these mediators after non-surgical periodontal treatment in patients with chronic periodontitis. A total of 20 subjects, 10 patients with chronic periodontitis (CP) and 10 periodontally healthy individuals were included in the study. Clinical parameters including plaque index (PI), gingival index (GI), probing depth (PD) and clinical attachment levels (CAL) were recorded. GCF and saliva samples were obtained at the beginning of the study from all individuals. GCF and saliva samples were re-collected from patients with CP at 1 month after non surgical periodontal therapy.
- Conditions
- Periodontitis
- Being tested
- Non-surgical periodontal treatment
- Keywords
- Gingival Crevicular Fluid, Lipid Mediator, 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
Mechanical non-surgical treatment were performed
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Periodontally healthy group |
| Chronic Periodontitis | Experimental | Patients with chronic periodontitis Receives: Procedure: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipoxin A4 levels
change of gingival crevicular fluid and salivary Lipoxin A4 levels from baseline at 1st month
Measured: 1st month
Secondary outcomes (2)
Prostaglandin E2 levels
change of gingival crevicular fluid and salivary Prostaglandin E2 levels from baseline at 1st month
Measured: 1st month
Leukotriene B4
change of gingival crevicular fluid and salivary Leukotriene B4 levels from baseline at 1st month
Measured: 1st month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 Oct 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Gökmenoğlu, Ordu University
- Investigators
- Ceren Gokmenoglu, Principal investigator, Ordu University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053660
- Sponsor's protocol ID
- Ordu dental faculty
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Non-Surgical Periodontal Treatment On Endogenous Anti-Inflammatory Lipid Mediators In Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT04053660
- Acronym / sponsor ID
- Ordu dental faculty
- Conditions
- Periodontitis
- Keywords
- Gingival Crevicular Fluid, Lipid Mediator, Periodontal Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Aug 2019 (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 evaluate the levels of lipoxin A4 (LXA4), prostaglandin E2 (PGE2) and leukotriene B4 (LTB4) in gingival crevicular fluid (GCF) and saliva in individuals with periodontal healthy and chronic periodontitis. In addition, the investigators evaluated the levels of these mediators after non-surgical periodontal treatment in patients with chronic periodontitis. A total of 20 subjects, 10 patients with chronic periodontitis (CP) and 10 periodontally healthy individuals were included in the study. Clinical parameters including plaque index (PI), gingival index (GI), probing depth (PD) and clinical attachment levels (CAL) were recorded. GCF and saliva samples were obtained at the beginning of the study from all individuals. GCF and saliva samples were re-collected from patients with CP at 1 month after non surgical periodontal therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Periodontally healthy group |
| Chronic Periodontitis | Experimental | Procedure: Non-surgical periodontal treatmentPatients with chronic periodontitis |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have at least 20 natural teeth, excluding third molars.
- Chronic periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm with gingival inflammation, and alveolar bone loss affecting >30% of the teeth, as detected on clinical and radiographical examinations.
- Periodontally healthy control group had no sign of gingival inflammation, no PD > 3mm and no evidence of attachment or bone loss.
Key exclusion criteria (8 listed)
- History of systemic disease.
- Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.
- Periodontal treatment during last 6 months that could affect periodontal status.
- Smoking.
- History of radiotherapy or chemotherapy.
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 treatmentMechanical non-surgical treatment were performed | Procedure or surgery | Chronic Periodontitis |
Primary outcome
Lipoxin A4 levels
Time frame: 1st month
change of gingival crevicular fluid and salivary Lipoxin A4 levels from baseline at 1st month
2 secondary outcomes
Prostaglandin E2 levels
Time frame: 1st month
Leukotriene B4
Time frame: 1st month
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 12 Aug 2019.
- 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.
Ceren Gokmenoglu principal investigator
Ordu University Faculty of Dentistry
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 Periodontitis, run by Ordu 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 8 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 12 Aug 2019. 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?
Lipoxin A4 levels (time frame: 1st month). 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 12 Aug 2019.