PeriodontitisNCT04496570
Resolvin D1 Levels in Patients With Periodontitis
A study testing periodontal therapy in people with Periodontitis, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study was to determine the levels of Resolvin D1 (RVD1) in the gingival crevicular fluid (GCF) and saliva of the patients with periodontitis (P) and also to investigate the effects of non-surgical periodontal treatments (NSPTs) on its levels. A total of 26 subjects (15 P, 11 healthy) were included. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- periodontal therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jul 2019to 29 Feb 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Stage 3, Grade B and generalized periodontitis patients
Who cannot join
- excessive forces;
- presence of systemic diseases
- administration of non-steroidal and anti-inflammatory drugs or antibiotic therapies within the previous 6 months
- having received non-surgical periodontal treatment within the past 6 months
- allergy or sensitivity to any drug,
- pregnancy, lactation
- current and former use of tobacco.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Resolvin D1 in Maintaining Oral Health
The purpose of the study was to determine the levels of Resolvin D1 (RVD1) in the gingival crevicular fluid (GCF) and saliva of the patients with periodontitis (P) and also to investigate the effects of non-surgical periodontal treatments (NSPTs) on its levels.
A total of 26 subjects (15 P, 11 healthy) were included. Clinical periodontal measurements, GCF and saliva samples were collected from each individual at baseline and 1 month after NSPTs in P group. RVD1 levels were determined by enzyme-linked immunosorbent assay (ELISA) method.
- Conditions
- Periodontitis
- Being tested
- periodontal therapy
- Keywords
- gingival crevicular fluid, resolvin D1
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal therapyProcedure or surgery
Non surgical periodontal therapy was performed to patients with peridontitis
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis patients | Active comparator | gingival crevicular fluid and saliva collection were taken before and after nonsurgical periodontal treatment Receives: Procedure: periodontal therapy |
| Healthy individuals | No intervention | gingival crevicular fluid and saliva collection were taken at baseline after oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical parameter (resolvin D1)
The changes in levels of resolvin D1 after periodontal treatment determined by ELISA.
Measured: Baseline and 1 month after NSPT
Secondary outcomes (4)
Probing pocket depth
The changes in probing pocket depth after periodontal treatment were evaluated
Measured: Baseline and 1 month after NSPT
Clinical attachment level (CAL)
The changes in CAL after periodontal treatment were evaluated
Measured: Baseline and 1 month after NSPT
Plaque index (PI)
The changes in PI after periodontal treatment were evaluated
Measured: Baseline and 1 month after NSPT
Gingival index (GI)
The changes in GI after periodontal treatment were evaluated
Measured: Baseline and 1 month after NSPT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start31 Jul 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 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.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Gökmenoğlu, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496570
- Sponsor's protocol ID
- Ordu University Dental Faculty
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Resolvin D1 in Maintaining Oral Health
- ClinicalTrials.gov ID
- NCT04496570
- Acronym / sponsor ID
- Ordu University Dental Faculty
- Conditions
- Periodontitis
- Keywords
- gingival crevicular fluid, resolvin D1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 3 Aug 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 purpose of the study was to determine the levels of Resolvin D1 (RVD1) in the gingival crevicular fluid (GCF) and saliva of the patients with periodontitis (P) and also to investigate the effects of non-surgical periodontal treatments (NSPTs) on its levels.
A total of 26 subjects (15 P, 11 healthy) were included. Clinical periodontal measurements, GCF and saliva samples were collected from each individual at baseline and 1 month after NSPTs in P group. RVD1 levels were determined by enzyme-linked immunosorbent assay (ELISA) method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis patients | Active comparator | Procedure: periodontal therapygingival crevicular fluid and saliva collection were taken before and after nonsurgical periodontal treatment |
| Healthy individuals | No intervention | –gingival crevicular fluid and saliva collection were taken at baseline after oral hygiene instructions |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Stage 3, Grade B and generalized periodontitis patients
Key exclusion criteria (7 listed)
- excessive forces;
- presence of systemic diseases
- administration of non-steroidal and anti-inflammatory drugs or antibiotic therapies within the previous 6 months
- having received non-surgical periodontal treatment within the past 6 months
- allergy or sensitivity to any drug,
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 |
|---|---|---|
| periodontal therapyNon surgical periodontal therapy was performed to patients with peridontitis | Procedure or surgery | Periodontitis patients |
Primary outcome
Biochemical parameter (resolvin D1)
Time frame: Baseline and 1 month after NSPT
The changes in levels of resolvin D1 after periodontal treatment determined by ELISA.
4 secondary outcomes
Probing pocket depth
Time frame: Baseline and 1 month after NSPT
Clinical attachment level (CAL)
Time frame: Baseline and 1 month after NSPT
Plaque index (PI)
Time frame: Baseline and 1 month after NSPT
Gingival index (GI)
Time frame: Baseline and 1 month after NSPT
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 19 Aug 2020.
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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 periodontal therapy 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 1 inclusion and 7 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 19 Aug 2020. 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?
Biochemical parameter (resolvin D1) (time frame: Baseline and 1 month after NSPT). 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 19 Aug 2020.