- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07287540
Anti-inflammatory Nutrition on the Outcomes of Non-surgical Periodontal Therapy
Evaluation of the Effects of Anti-inflammatory Nutrition on the Outcomes of Non-surgical Periodontal Therapy in Individuals With Periodontitis
This study aimed to determine the effect of anti-inflammatory nutrition on non-surgical periodontal treatment in individuals with periodontitis by evaluating gingival crevicular fluid (GCF) and serum biomarkers and clinical periodontal parameters.
A total of 100 volunteers identified as having a pro-inflammatory diet (Q3 and Q4) will be included in the study. Individuals will be assigned to two groups. These groups will then be further divided into two groups based on whether or not they will receive anti-inflammatory nutrition education. Group Q3-1 (n=25) will receive non-surgical periodontal treatment and anti-inflammatory nutrition education. Group Q3-2 (n=25) will receive only non-surgical periodontal treatment. Group Q4-1 (n=25) will receive non-surgical periodontal treatment and anti-inflammatory nutrition education. Group Q4-2 (n=25) will receive only non-surgical periodontal treatment. After the periodontal index measurements are completed, the patients will receive non-surgical periodontal treatment. GCF and serum samples, periodontal clinical parameters and Dietary Inflammatory Index will be collected 3 times: at baseline, 1.5 and 3 months after non-surgical periodontal treatment. Levels of interleukin (IL)-1β, IL-10, tumor necrosis factor (TNF)-α, total oxidant status (TOS), total antioxidant status (TAS), and C-reactive protein (CRP) will be assessed from these samples. This will investigate the role of anti-inflammatory nutrition in reducing periodontal inflammation and increasing treatment success.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hatice Yemenoglu
- Phone Number: +905052977517
- Email: htcymnglu@hotmail.com
Study Locations
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-
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Rize, Turkey (Türkiye), 53020
- Recruiting
- Recep Tayyip Erdogan University
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Contact:
- Hatice Yemenoglu
- Phone Number: +904642220000
- Email: htcymnglu@hotmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being systemically healthy
- Not smoking
- Not using anti-inflammatory drugs in the last 3 months, antibiotics, or systemic corticosteroids in the last 6 months
- Not being pregnant or lactating
- Not having received periodontal treatment in the last 6 months
- Having at least 20 teeth in the mouth
- Being diagnosed with periodontitis by the investigator
- Having a dietary inflammatory index >0
Exclusion Criteria:
- Having a systemic disease
- Smoking
- Using anti-inflammatory drugs within the last 3 months, antibiotics within the last 6 months, or systemic corticosteroids
- Being pregnant or lactating
- Having received periodontal treatment within the last 6 months
- Having fewer than 20 teeth in the mouth
- No periodontitis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Q3-1: Nonsurgical periodontal treatment and anti-inflammatory nutrition education
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All participants will receive nonsurgical periodontal treatment
Participants in Groups Q3-1 and Q4-1 will receive anti-inflammatory nutrition education
|
|
Q3-2: Only nonsurgical periodontal treatment
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All participants will receive nonsurgical periodontal treatment
|
|
Q4-1: Nonsurgical periodontal treatment and anti-inflammatory nutrition education
|
All participants will receive nonsurgical periodontal treatment
Participants in Groups Q3-1 and Q4-1 will receive anti-inflammatory nutrition education
|
|
Q4-2: Only nonsurgical periodontal treatment
|
All participants will receive nonsurgical periodontal treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
periodontal pocket depth
Time Frame: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
It will be calculated by measuring the distance between the gingival margin and the pocket base.
It will be measured from the six surfaces of each tooth and the average will be taken higher scores indicate worse outcome.
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baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
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Clinical attachment loss
Time Frame: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
It will be calculated by measuring the distance between the cementoenemal border and the pocket base.
It will be measured from the six surfaces of each tooth and the average will be taken higher scores indicate worse outcome.
|
baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
interleukin (IL)-1β level
Time Frame: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
IL-1β levels will be measured with biochemical kits.
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baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
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interleukin (IL)-10 level
Time Frame: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
IL-10 levels will be measured with biochemical kits.
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baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
|
tumor necrosis factor (TNF)-α level
Time Frame: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
TNF-α levels will be measured with biochemical kits.
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baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
|
serum total oxidant status (TOS) level
Time Frame: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
TOS levels in serum will be measured with biochemical kits.
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baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
|
serum total antioxidant status (TAS) level
Time Frame: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
TAS levels in serum will be measured with biochemical kits.
|
baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
|
serum C-reactive protein (CRP) level
Time Frame: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
CRP levels in serum will be measured with biochemical kits.
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baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Recep TayyipErdoğan University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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