Chronic Periodontitis, GeneralizedNCT04597073
Measurement of Oncostatin M, Leukemia Inhibitory Factor and Interleukin-11 Levels of Patients With Periodontal Disease
A study testing Initial Periodontal Therapy in people with Chronic Periodontitis, Generalized and Gingivitis, run by Ataturk University.
Trial summary
This study aims to determine Oncostatin M (OSM), Leukemia inhibitory factor (LIF), and Interleukin-11 (IL-11) levels in gingival crevicular fluid (GCF), saliva, and serum in periodontally healthy individuals and those with gingivitis and chronic periodontitis before and after periodontal treatment and to evaluate the… Read more about this study
- Who is it for?
- Ages 20 to 56 years
- Conditions the study is for
- Chronic Periodontitis, Generalized, Gingivitis
- What is being tested?
- Initial 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
- 72 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Aug 2014
- 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 20 to 56 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- systemically healthy
- non-smokers
Who cannot join
- smokers
- pregnancy or lactation
- individuals with any systemic disease
- individuals who have had periodontal treatment in the last six months
About this study
Official title: Measurement of Oncostatin M, Leukemia Inhibitory Factor and Interleukin-11 Levels in Serum, Saliva, and Gingival Crevicular Fluid of Patients With Periodontal Disease
This study aims to determine Oncostatin M (OSM), Leukemia inhibitory factor (LIF), and Interleukin-11 (IL-11) levels in gingival crevicular fluid (GCF), saliva, and serum in periodontally healthy individuals and those with gingivitis and chronic periodontitis before and after periodontal treatment and to evaluate the relationship between these cytokine levels and clinical periodontal parameters.
- Conditions
- Chronic Periodontitis, Generalized, Gingivitis
- Being tested
- Initial Periodontal Therapy
- Keywords
- Chronic Periodontitis, Gingival Crevicular Fluid, Leukemia Inhibitory Factor, Oncostatin M, Interleukin-11, Periodontal Therapy, Gingivitis
- Medical subject headings
- Chronic Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial Periodontal TherapyProcedure or surgery
Oral hygiene education, including the use of toothbrushes and dental floss and/or interproximal brushes, was given to them. After one week Chronic Periodontitis group received nonsurgical periodontal therapy consisting of scaling and root planing (quadrant by quadrant) using manual scalers and curettes under local anesthesia. No antibiotics or any medications were prescribed during the treatment. Periodontal treatment was performed by the same investigator
| Study group | Role | What they receive |
|---|---|---|
| Healthy | No intervention | included individuals with probing depth (PD) ≤3mm, no sites with attachment loss, and no radiographic evidence of alveolar bone resorption. They exhibited no sign of inflammation (GI=0). |
| Gingivitis | Experimental | had varying degrees of gingival inflammation (GI≥1), PD≤3mm with no clinical attachment loss or with no alveolar bone destruction. Receives: Procedure: Initial Periodontal Therapy |
| Chronic Periodontitis | Experimental | was defined as those who were with PD ≥ 4mm, clinical attachment loss (CAL) ≥ 2mm, and who had bone loss affecting >30% of the existing teeth on clinical and radiographic examination. Receives: Procedure: Initial Periodontal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level baseline
As described by Silness\&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Scores 0: No plaque. scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
Scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
Scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas/4 plaque index individual= scores from 28 tooth/28
Measured: baseline (before treatment)
Plaque index baseline
As described by Silness\&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3.
Scores 0: No plaque. scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
Scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
Scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas. plaque index individual= scores from 28 tooth
Measured: baseline (before treatment)
Gingival index baseline
As described by Löe\&Silness 1963; The bleeding is assessed by probing gently along the wall of soft tissue of the gingival sulcus. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3.
Score 0 - Normal, healthy gingival with sharp, non-inflamed margins. score 1 - Marginal gingivitis with minimal inflammation and edema at the free gingival. No bleeding on probing.
Score 2 - Moderate gingivitis with a wider band of inflammation and bleeding upon probing.
Score 3 - Advanced gingivitis with inflammation clinically reaching the mucogingival junction usually with ulceration.
Score 0 considered healthy gingiva, score 3 assessed advanced gingival disease. gingival index for a tooth=scores from 4 areas/4 gingival index individual= scores from 28 tooth/28
Measured: baseline (before treatment)
Probing of depth baseline
Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe
Measured: baseline (before treatment)
Biochemical outcomes baseline
In this study, biochemical parameters including OSM,LIF, IL-11 were measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) methods on Gingival Crevicular Fluid, saliva and serum at baseline
Measured: baseline (before treatment)
Secondary outcomes (5)
Clinical attachment level after 8 weeks
Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe
Measured: 8 weeks after treatment
Plaque index after 8 weeks
As described by Silness\&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3.
Scores 0: No plaque scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
Scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. Scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas/4 plaque index individual= scores from 28 tooth/28
Measured: 8 weeks after treatment
Gingival index after 8 weeks
As described by Löe\&Silness 1963; The bleeding is assessed by probing gently along the wall of soft tissue of the gingival sulcus. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3.
Score 0 - Normal, healthy gingival with sharp, non-inflamed margins. score 1 - Marginal gingivitis with minimal inflammation and edema at the free gingival. No bleeding on probing. Score 2 - Moderate gingivitis with a wider band of inflammation and bleeding upon probing.
Score 3 - Advanced gingivitis with inflammation clinically reaching the mucogingival junction usually with ulceration.
Score 0 considered healthy gingiva, score 3 assessed advanced gingival disease. gingival index for a tooth=scores from 4 areas/4 gingival index individual= scores from 28 tooth/28
Measured: 8 weeks after treatment
Probing of dept after 8 weeks
Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe
Measured: 8 weeks after treatment
Biochemical outcomes after 8 weeks
In this study, biochemical parameters including OSM,LIF, IL-11 were measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) methods on Gingival Crevicular Fluid, saliva and serum at 8 weeks
Measured: 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study startMar 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Periodontitis, GeneralizedStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Aydin, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597073
- Sponsor's protocol ID
- OncosM,LIF,IL-11
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2020
- Last updated
- 22 Oct 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Oncostatin M, Leukemia Inhibitory Factor and Interleukin-11 Levels in Serum, Saliva, and Gingival Crevicular Fluid of Patients With Periodontal Disease
- ClinicalTrials.gov ID
- NCT04597073
- Acronym / sponsor ID
- OncosM,LIF,IL-11
- Conditions
- Chronic Periodontitis, Generalized, Gingivitis
- Keywords
- Chronic Periodontitis, Gingival Crevicular Fluid, Leukemia Inhibitory Factor, Oncostatin M, Interleukin-11, Periodontal Therapy, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Oct 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.
This study aims to determine Oncostatin M (OSM), Leukemia inhibitory factor (LIF), and Interleukin-11 (IL-11) levels in gingival crevicular fluid (GCF), saliva, and serum in periodontally healthy individuals and those with gingivitis and chronic periodontitis before and after periodontal treatment and to evaluate the relationship between these cytokine levels and clinical periodontal parameters.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | No intervention | –included individuals with probing depth (PD) ≤3mm, no sites with attachment loss, and no radiographic evidence of alveolar bone resorption. They exhibited no sign of inflammation (GI=0). |
| Gingivitis | Experimental | Procedure: Initial Periodontal Therapyhad varying degrees of gingival inflammation (GI≥1), PD≤3mm with no clinical attachment loss or with no alveolar bone destruction. |
| Chronic Periodontitis | Experimental | Procedure: Initial Periodontal Therapywas defined as those who were with PD ≥ 4mm, clinical attachment loss (CAL) ≥ 2mm, and who had bone loss affecting >30% of the existing teeth on clinical and radiographic examination. |
Who may qualify
- Ages
- 20 to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- systemically healthy
- non-smokers
Key exclusion criteria (4 listed)
- smokers
- pregnancy or lactation
- individuals with any systemic disease
- individuals who have had periodontal treatment in the last six 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 |
|---|---|---|
| Initial Periodontal TherapyOral hygiene education, including the use of toothbrushes and dental floss and/or interproximal brushes, was given to them. After one week Chronic Periodontitis group received nonsurgical periodontal therapy consisting of scaling and root planing (quadrant by quadrant) using manual scalers and curettes under local anesthesia. No antibiotics or any medications were prescribed during the treatment. Periodontal treatment was performed by the same investigator | Procedure or surgery | Chronic Periodontitis, Gingivitis |
Primary outcome
Clinical attachment level baseline
Time frame: baseline (before treatment)
As described by Silness\&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Scores 0: No plaque. scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. Scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. Scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas/4 plaque index individual= scores from 28 tooth/28
Plaque index baseline
Time frame: baseline (before treatment)
As described by Silness\&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Scores 0: No plaque. scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. Scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. Scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas. plaque index individual= scores from 28 tooth
Gingival index baseline
Time frame: baseline (before treatment)
As described by Löe\&Silness 1963; The bleeding is assessed by probing gently along the wall of soft tissue of the gingival sulcus. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Score 0 - Normal, healthy gingival with sharp, non-inflamed margins. score 1 - Marginal gingivitis with minimal inflammation and edema at the free gingival. No bleeding on probing. Score 2 - Moderate gingivitis with a wider band of inflammation and bleeding upon probing. Score 3 - Advanced gingivitis with inflammation clinically reaching the mucogingival junction usually with ulceration. Score 0 considered healthy gingiva, score 3 assessed advanced gingival disease. gingival index for a tooth=scores from 4 areas/4 gingival index individual= scores from 28 tooth/28
Probing of depth baseline
Time frame: baseline (before treatment)
Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe
Biochemical outcomes baseline
Time frame: baseline (before treatment)
In this study, biochemical parameters including OSM,LIF, IL-11 were measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) methods on Gingival Crevicular Fluid, saliva and serum at baseline
5 secondary outcomes
Clinical attachment level after 8 weeks
Time frame: 8 weeks after treatment
Plaque index after 8 weeks
Time frame: 8 weeks after treatment
Gingival index after 8 weeks
Time frame: 8 weeks after treatment
Probing of dept after 8 weeks
Time frame: 8 weeks after treatment
Biochemical outcomes after 8 weeks
Time frame: 8 weeks after treatment
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 22 Oct 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.
Questions about this trial
What is this clinical trial studying?
A study testing Initial Periodontal Therapy in people with Chronic Periodontitis, Generalized and Gingivitis, run by Ataturk University.
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 2 inclusion and 4 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical attachment level baseline (time frame: baseline (before treatment)). The study lists 5 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 22 Oct 2020.