Periodontal DiseasesNCT06291454
GCF Levels of Chemokines in Periodontitis
An observational study of Periodontal Diseases, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine CCL19/MIP3beta(β) and CCL20/MIP3alpha(α) in the gingival crevicular fluid (GCF) of the patients with different periodontitis phenotypes. A total of 72 individuals, 24 with Stage III Grade B periodontitis (Group 1), 24 with Stage III Grade C periodontitis (Group 2), and 24 periodontally… Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Routine periodontal examination
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Dec 2023
- How long will I take part?
- 1 Year
- 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 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * Group 1: Stage III Grade B periodontitis group * Group 2: Stage III Grade C periodontitis group * Group 3: Periodontally healthy control group
Who may be able to join
- Have at least 20 natural teeth, excluding third molars.
- 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.
- Current pregnancy, lactation or menopause.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ordu University, Faculty of Dentistry
Ordu, 52100
About this study
Official title: CCL19/MIP3beta and CCL20/MIP3alpha Levels in the Gingival Crevicular Fluid of the Patients With Stage III Grade B and C Periodontitis
This study aimed to determine CCL19/MIP3beta(β) and CCL20/MIP3alpha(α) in the gingival crevicular fluid (GCF) of the patients with different periodontitis phenotypes.
A total of 72 individuals, 24 with Stage III Grade B periodontitis (Group 1), 24 with Stage III Grade C periodontitis (Group 2), and 24 periodontally healthy (control group) (Group 3), were included in the study. GCF and clinical periodontal parameters were obtained at baseline. MIP3β and MIP3α levels in GCF were determined by ELISA.
- Conditions
- Periodontal Diseases
- Being tested
- Routine periodontal examination
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine periodontal examinationDiagnostic test
In all of the patients, the following indexes were used routinely for the periodontal examination: Sillness-Löe's plaque index (PI) (Silness \& Löe, 1964), Löe-Sillness's gingival index (GI)(Löe \& Silness, 1963), probing depth (PD) to measure the extent and severity of periodontal disease, clinical attachment level (CAL), and bleeding on probing (BOP)(Ainamo \& Bay, 1975) to determine activity. In addition, routine radiographic evaluations were performed to determine bone levels.GCF samples were collected using standardized filter papers.
| Study group | Role | What they receive |
|---|---|---|
| Stage III Grade B periodontitis group (Group 1) | Stage III Grade B periodontitis patients and systemically healthy Receives: Diagnostic Test: Routine periodontal examination | |
| Stage III Grade C periodontitis group (Group 2) | Stage III Grade C periodontitis patients and systemically healthy Receives: Diagnostic Test: Routine periodontal examination | |
| Control group (Group 3) | Periodontally healthy (control group) and systemically healthy patients Receives: Diagnostic Test: Routine periodontal examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
CCL19/MIP3beta(β) levels
CCL19/MIP3beta(β) levels in the gingival crevicular fluid (GCF) of the all groups
Measured: Baseline
CCL20/MIP3alpha(α) levels
CCL20/MIP3alpha(α) levels in the gingival crevicular fluid (GCF)
Measured: Baseline
Secondary outcomes (2)
CCL19/MIP3beta(β) levels and clinical parameters
Correlation between CCL19/MIP3beta(β) levels in the gingival crevicular fluid (GCF) of the all groups and all clinical parameters
Measured: Baseline
CCL20/MIP3alpha(α) levels and clinical parameters
Correlation between CCL20/MIP3alpha(α) levels in the gingival crevicular fluid (GCF) of the all groups and all clinical parameters
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Jan 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.Dr. Figen ÖNGÖZ DEDE, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291454
- Sponsor's protocol ID
- 741100
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 8 Mar 2024
- 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 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCL19/MIP3beta and CCL20/MIP3alpha Levels in the Gingival Crevicular Fluid of the Patients With Stage III Grade B and C Periodontitis
- ClinicalTrials.gov ID
- NCT06291454
- Acronym / sponsor ID
- 741100
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 4 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.
This study aimed to determine CCL19/MIP3beta(β) and CCL20/MIP3alpha(α) in the gingival crevicular fluid (GCF) of the patients with different periodontitis phenotypes.
A total of 72 individuals, 24 with Stage III Grade B periodontitis (Group 1), 24 with Stage III Grade C periodontitis (Group 2), and 24 periodontally healthy (control group) (Group 3), were included in the study. GCF and clinical periodontal parameters were obtained at baseline. MIP3β and MIP3α levels in GCF were determined by ELISA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage III Grade B periodontitis group (Group 1) | – | Diagnostic Test: Routine periodontal examinationStage III Grade B periodontitis patients and systemically healthy |
| Stage III Grade C periodontitis group (Group 2) | – | Diagnostic Test: Routine periodontal examinationStage III Grade C periodontitis patients and systemically healthy |
| Control group (Group 3) | – | Diagnostic Test: Routine periodontal examinationPeriodontally healthy (control group) and systemically healthy patients |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Group 1: Stage III Grade B periodontitis group * Group 2: Stage III Grade C periodontitis group * Group 3: Periodontally healthy control group
Key inclusion criteria (3 listed)
- Have at least 20 natural teeth, excluding third molars.
- 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 (6 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 |
|---|---|---|
| Routine periodontal examinationIn all of the patients, the following indexes were used routinely for the periodontal examination: Sillness-Löe's plaque index (PI) (Silness \& Löe, 1964), Löe-Sillness's gingival index (GI)(Löe \& Silness, 1963), probing depth (PD) to measure the extent and severity of periodontal disease, clinical attachment level (CAL), and bleeding on probing (BOP)(Ainamo \& Bay, 1975) to determine activity. In addition, routine radiographic evaluations were performed to determine bone levels.GCF samples were collected using standardized filter papers. | Diagnostic test | Control group (Group 3), Stage III Grade B periodontitis group (Group 1), Stage III Grade C periodontitis group (Group 2) |
Primary outcome
CCL19/MIP3beta(β) levels
Time frame: Baseline
CCL19/MIP3beta(β) levels in the gingival crevicular fluid (GCF) of the all groups
CCL20/MIP3alpha(α) levels
Time frame: Baseline
CCL20/MIP3alpha(α) levels in the gingival crevicular fluid (GCF)
2 secondary outcomes
CCL19/MIP3beta(β) levels and clinical parameters
Time frame: Baseline
CCL20/MIP3alpha(α) levels and clinical parameters
Time frame: Baseline
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 8 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 Periodontal Diseases, 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 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 8 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?
CCL19/MIP3beta(β) levels (time frame: Baseline). 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 8 Mar 2024.