PeriodontitisNCT06225154
Effect of Periodontal Treatment on Adipokine Levels
A study testing Non-surgical periodontal treatment in people with Periodontitis and Diabetes Mellitus, Type 2, run by Marmara University at 2 sites in 2 countries.
Trial summary
The present study aimed to determine the effect of non-surgical periodontal treatment (NSPT) on serum and salivary adipokine and interleukin-1β levels in periodontitis patients with or without type 2 Diabetes Mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Diabetes Mellitus, Type 2
- 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
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2015to Nov 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diabetes mellitus should be diagnosed for ≥1 year and HbA1c level should be at least %6,5
- Periodontitis should be diagnosed for at least 4 teeth with probing depth ≥5 mm with bleeding on probing (BOP) and also radiographic alveolar bone loss should be presence
- Presence of at least 15 teeth
Who cannot join
- Received antibiotic treatment in the previous 3 months
- Smokers
- Pregnancy and lactation
- Received periodontal treatment in the previous 6 months
- Presence of less than 15 teeth
- Having major diabetic complications
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Finland1 site
Department of Periodontology, Institute of Dentistry, Turku University
Turku, Lemminkäisenkatu 2, FI-20520
Turkey (Türkiye)1 site
Marmara University, Faculty of Dentistry, Department of Periodontology
Istanbul, Maltepe, 34854
About this study
Official title: Effect of Non-Surgical Periodontal Treatment on Adipokine Levels in Diabetes Mellitus: A Controlled Clinical Trial
The present study aimed to determine the effect of non-surgical periodontal treatment (NSPT) on serum and salivary adipokine and interleukin-1β levels in periodontitis patients with or without type 2 Diabetes Mellitus (T2DM).
Read the detailed description
The present study aimed to determine the effect of non-surgical periodontal treatment (NSPT) on serum and salivary adipokine and interleukin (IL)-1β levels in periodontitis patients with or without type 2 Diabetes Mellitus (T2DM). A total of 80 patients; 20 healthy, 20 T2DM with periodontitis (P), 20 T2DM periodontally healthy, 20 systemically healthy with P were included in this study. At baseline, serum and saliva samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received NSPT in 4 sessions. Clinical parameters were re-measured and samples were re-collected at 1 and 3 months after treatment. Serum and salivary levels of adipokines and IL-1β were analyzed using a flow cytometry-based technique of Lumina® map™. Data were analyzed using appropriate statistical tests.
- Conditions
- Periodontitis, Diabetes Mellitus, Type 2
- Being tested
- Non-surgical periodontal treatment
- Keywords
- adipokines, diabetes mellitus, inflammation, periodontitis
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Type 2, Diabetes Mellitus, Inflammation
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
Non-surgical periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Periodontally healthy subjects with type 2 diabetes mellitus or systemically healthy didn't have an initial periodontal treatment |
| Non-surgical periodontal treatment | Experimental | Non-surgical periodontal treatment was performed in a quadrant-wise manner at 1-week intervals for periodontitis patients systemically healthy or with type 2 diabetes mellitus. Receives: Procedure: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum and Salivary Resistin Levels (pg/ml)
Serum and salivary resistin levels
Measured: Change between baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and Salivary Leptin Levels (pg/ml)
Serum and salivary leptin levels
Measured: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and Salivary Visfatin Levels (pg/ml)
Serum and salivary visfatin levels
Measured: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and saliva IL-1β levels (pg/ml)
Serum and salivary IL-1β levels
Measured: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Secondary outcomes (1)
HbA1c ( %)
Glycated Hemoglobin Level %
Measured: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study startFeb 2015
- Primary completionMay 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku
- Responsible party
- Sponsor
- Investigators
- Basak Dogan, Prof. Dr., Study director, Department of Periodontology, Faculty of Dentistry, Marmara UniversityYaprak Kalkan, Dt., Principal investigator, Department of Periodontology, Institute of Health Sciences, Marmara UniversityUlvi Kahraman Gürsoy, Assoc. Prof., Study chair, Department of Periodontology, Institute of Dentistry, Turku UniversityMervi Gürsoy, Assoc. Prof., Study chair, Department of Periodontology, Institute of Dentistry, Turku UniversityEija Könönen, Prof. Dr., Study chair, Department of Periodontology, Institute of Dentistry, Turku University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225154
- Sponsor's protocol ID
- SAG-C-DRP-100216-0041
- Status last verified
- Jan 2024
- First submitted
- 1 Feb 2018
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Furugen R, Hayashida H, Yamaguchi N, Yoshihara A, Ogawa H, Miyazaki H, Saito T. The relationship between periodontal condition and serum levels of resistin and adiponectin in elderly Japanese. J Periodontal Res. 2008 Oct;43(5):556-62. doi: 10.1111/j.1600-0765.2008.01085.x. Epub 2008 Jun 28.
PubMed 18565135Gokhale NH, Acharya AB, Patil VS, Trivedi DJ, Setty S, Thakur SL. Resistin levels in gingival crevicular fluid of patients with chronic periodontitis and type 2 diabetes mellitus. J Periodontol. 2014 Apr;85(4):610-7. doi: 10.1902/jop.2013.130092. Epub 2013 Jun 27.
PubMed 23805816Goncalves TE, Zimmermann GS, Figueiredo LC, Souza Mde C, da Cruz DF, Bastos MF, da Silva HD, Duarte PM. Local and serum levels of adipokines in patients with obesity after periodontal therapy: one-year follow-up. J Clin Periodontol. 2015 May;42(5):431-9. doi: 10.1111/jcpe.12396. Epub 2015 Apr 30.
PubMed 25858047
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Surgical Periodontal Treatment on Adipokine Levels in Diabetes Mellitus: A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06225154
- Acronym / sponsor ID
- SAG-C-DRP-100216-0041
- Conditions
- Periodontitis, Diabetes Mellitus, Type 2
- Keywords
- adipokines, diabetes mellitus, inflammation, periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- University of Turku
- Study start
- Feb 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 25 Jan 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 present study aimed to determine the effect of non-surgical periodontal treatment (NSPT) on serum and salivary adipokine and interleukin-1β levels in periodontitis patients with or without type 2 Diabetes Mellitus (T2DM).
Detailed description
The present study aimed to determine the effect of non-surgical periodontal treatment (NSPT) on serum and salivary adipokine and interleukin (IL)-1β levels in periodontitis patients with or without type 2 Diabetes Mellitus (T2DM). A total of 80 patients; 20 healthy, 20 T2DM with periodontitis (P), 20 T2DM periodontally healthy, 20 systemically healthy with P were included in this study. At baseline, serum and saliva samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received NSPT in 4 sessions. Clinical parameters were re-measured and samples were re-collected at 1 and 3 months after treatment. Serum and salivary levels of adipokines and IL-1β were analyzed using a flow cytometry-based technique of Lumina® map™. Data were analyzed using appropriate statistical tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Periodontally healthy subjects with type 2 diabetes mellitus or systemically healthy didn't have an initial periodontal treatment |
| Non-surgical periodontal treatment | Experimental | Procedure: Non-surgical periodontal treatmentNon-surgical periodontal treatment was performed in a quadrant-wise manner at 1-week intervals for periodontitis patients systemically healthy or with type 2 diabetes mellitus. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diabetes mellitus should be diagnosed for ≥1 year and HbA1c level should be at least %6,5
- Periodontitis should be diagnosed for at least 4 teeth with probing depth ≥5 mm with bleeding on probing (BOP) and also radiographic alveolar bone loss should be presence
- Presence of at least 15 teeth
Key exclusion criteria (6 listed)
- Received antibiotic treatment in the previous 3 months
- Smokers
- Pregnancy and lactation
- Received periodontal treatment in the previous 6 months
- Presence of less than 15 teeth
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 treatmentNon-surgical periodontal treatment was performed in a quadrant-wise manner at 1-week intervals. | Procedure or surgery | Non-surgical periodontal treatment |
Primary outcome
Serum and Salivary Resistin Levels (pg/ml)
Time frame: Change between baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and salivary resistin levels
Serum and Salivary Leptin Levels (pg/ml)
Time frame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and salivary leptin levels
Serum and Salivary Visfatin Levels (pg/ml)
Time frame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and salivary visfatin levels
Serum and saliva IL-1β levels (pg/ml)
Time frame: Change baseline, 1 and 3 months after non-surgical periodontal treatment
Serum and salivary IL-1β levels
1 secondary outcome
HbA1c ( %)
Time frame: Change baseline, 1 and 3 months after non-surgical periodontal 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 30 Jan 2024.
- Background: PubMed 18565135Furugen R, Hayashida H, Yamaguchi N, Yoshihara A, Ogawa H, Miyazaki H, Saito T. The relationship between periodontal condition and serum levels of resistin and adiponectin in elderly Japanese. J Periodontal Res. 2008 Oct;43(5):556-62. doi: 10.1111/j.1600-0765.2008.01085.x. Epub 2008 Jun 28.
- Background: PubMed 23805816Gokhale NH, Acharya AB, Patil VS, Trivedi DJ, Setty S, Thakur SL. Resistin levels in gingival crevicular fluid of patients with chronic periodontitis and type 2 diabetes mellitus. J Periodontol. 2014 Apr;85(4):610-7. doi: 10.1902/jop.2013.130092. Epub 2013 Jun 27.
- Background: PubMed 25858047Goncalves TE, Zimmermann GS, Figueiredo LC, Souza Mde C, da Cruz DF, Bastos MF, da Silva HD, Duarte PM. Local and serum levels of adipokines in patients with obesity after periodontal therapy: one-year follow-up. J Clin Periodontol. 2015 May;42(5):431-9. doi: 10.1111/jcpe.12396. Epub 2015 Apr 30.
- 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.
Basak Dogan, Prof. Dr. study director
Department of Periodontology, Faculty of Dentistry, Marmara University
Yaprak Kalkan, Dt. principal investigator
Department of Periodontology, Institute of Health Sciences, Marmara University
Ulvi Kahraman Gürsoy, Assoc. Prof. study chair
Department of Periodontology, Institute of Dentistry, Turku University
2 sites in 2 countries: 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 and Diabetes Mellitus, Type 2, run by Marmara University at 2 sites in 2 countries.
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 30 Jan 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 Finland, 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?
Serum and Salivary Resistin Levels (pg/ml) (time frame: Change between baseline, 1 and 3 months after non-surgical periodontal treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06225154, which also lists 3 linked publications.
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 30 Jan 2024.