- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05864768
The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study
Experimental Gingivitis in Omnivores and Vegans. The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study
Diet can influence the body's healing and repair mechanisms. A dietary imbalance obviously cannot trigger periodontal disease in the absence of a primum movens, which is bacterial plaque. However, it can condition its severity and extent by altering the permeability of the oral mucosa, the effectiveness of the immune response and the reparative potential of the gingival tissues.
Nutraceuticals is the science that studies the effects of the so-called food-drug, i.e. those foods that contain substances capable of performing a pharmacological function, modifying the functions of the organism. In particular, some molecules that are assimilated through various foods are able to penetrate the cell nucleus and influence, through an epigenetic mechanism, the expression or otherwise of some genes. The aim of the present longitudinal quasi-experimental study was to evaluate the gingival inflammatory response to experimentally induced plaque accumulation in periodontally healthy vegans and omnivores and to explore whether systemic biomarkers mediated the observed clinical effects.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
CH
-
Chieti, CH, Italy, 66100
- G. d'Annunzio University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Optimal systemic health conditions
- Non-Smoking
- Absence of cardio-vascular pathologies
- Absence of pulmonary pathologies
- Non-diabetic
- Not pregnant
- Presence of 28 teeth without prosthetic crowns or subgingival/juxtagingival interproximal restorations
- FMPS <20% at baseline
- FMBS <20% at baseline
- Omnivorous or vegan diet for at least a year
- Absence of periodontitis
Exclusion Criteria:
- Smokers
- Presence of systemic pathologies
- Presence of cardio-vascular disease
- Presence of periodontitis
- FMPS>20% at baseline
- FMBS>20% at baseline
- Pregnant women
- Presence of blood pathologies
- Taking medicines (hydantoins, nifedipine or cyclosporine)
- Taking oral contraceptives
- Bacterial, viral or fungal infections
- Idiopathic gingival fibromatosis
- Mucocutaneous disorders
- Allergic reactions to toothpastes and mouthwashes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with a vegan diet
After excluding patients with clinical signs of periodontitis, the patients recruited at baseline underwent prophylaxis and home oral hygiene instructions were given with brushing and flossing in order to reduce the parameters of inflammation and the presence of plaque (FMPS andFMBS). After patient recruitment and prior to baseline assessment, fasting venous blood samples will be collected to evaluate metabolic, inflammatory, oxidative stress, and hematological parameters, including fasting glucose, lipid profile, CRP, d-ROMs, BAP, and complete blood count. The Systemic Immune-Inflammation Index (SII) will be calculated. After 15 days from baseline (T0) all patients were recorded the parameters of FMPS, FMBS, and Eastman Interdental Bleeding Index (EIBI) and were asked to stop using dental floss and mouthwash. All patients were recalled weekly 4 times after T0 (T1, T2, T3,T4) in order to monitor the parameters of inflammation and plaque accumulation by recording FMBS, FMPS and EIBI. |
At baseline, following the compilation of a periodontal chart in which pocket probing depth (PPD) and FMPS and FMBS were recorded, patients with pathological probing depths >3mm associated with periodontitis were excluded. Healthy patients underwent a prophylaxis session and oral hygiene instructions with brushing and flossing. A mouthwash based on chlorhexifdine 0.20% to be used twice a day was prescribed. At 15 days from the baseline (T0) the periodontal chart was compiled again and the parameters relating to PD, FMP, FMBS and the Eastman Interdental Bleeding Index (EIBI) were collected. Patients with FMBS and FMPS values >20% were excluded. From time T0 all patients were asked to suspend the interdental hygiene maneuvers by interrupting the use of dental floss and abandoning the use of mouthwash. All patients were recalled weekly, for a total of 4 times (T1, T2, T3, T4) in which parameters related to FMBS, FMPS and EIBI were recorded. |
|
Active Comparator: Patients with an omnivorous diet
After excluding patients with clinical signs of periodontitis, the patients recruited at baseline underwent prophylaxis and home oral hygiene instructions were given with brushing and flossing in order to reduce the parameters of inflammation and the presence of plaque (FMPS and FMBS). After patient recruitment and prior to baseline assessment, fasting venous blood samples will be collected to evaluate metabolic, inflammatory, oxidative stress, and hematological parameters, including fasting glucose, lipid profile, CRP, d-ROMs, BAP, and complete blood count. The Systemic Immune-Inflammation Index (SII) will be calculated. After 15 days from baseline (T0) all patients were recorded the parameters of FMPS, FMBS and Eastman Interdental Bleeding Index (EIBI) and were asked to stop using dental floss and mouthwash. All patients were recalled weekly 4 times after T0 (T1, T2, T3, T4) in order to monitor the parameters of inflammation and plaque accumulation by recording FMBS, FMPS and EIBI. |
At baseline, following the compilation of a periodontal chart in which pocket probing depth (PPD) and FMPS and FMBS were recorded, patients with pathological probing depths >3mm associated with periodontitis were excluded. Healthy patients underwent a prophylaxis session and oral hygiene instructions with brushing and flossing. A mouthwash based on chlorhexifdine 0.20% to be used twice a day was prescribed. At 15 days from the baseline (T0) the periodontal chart was compiled again and the parameters relating to PD, FMP, FMBS and the Eastman Interdental Bleeding Index (EIBI) were collected. Patients with FMBS and FMPS values >20% were excluded. From time T0 all patients were asked to suspend the interdental hygiene maneuvers by interrupting the use of dental floss and abandoning the use of mouthwash. All patients were recalled weekly, for a total of 4 times (T1, T2, T3, T4) in which parameters related to FMBS, FMPS and EIBI were recorded. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eastman Interdental Bleeding Index
Time Frame: Four weeks
|
A wooden wedge is inserted buccally into the interdental space 1-2 mm, perpendicular to the long axis of the tooth, to assess for the presence of interdental inflammation (Yes/No).
|
Four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Full Mouth Plaque Score
Time Frame: Four weeks
|
Index that evaluates the general presence of bacterial plaque for all teeth.
Through the passage of the probe, the presence of plaque deposits is reported for 4 surfaces for each tooth.
A ratio is made between the contaminated surfaces and the total surfaces investigated to obtain a percentage value.
|
Four weeks
|
|
Full Mouth Bleeding Score
Time Frame: Four weeks
|
Index that evaluates the general presence of bleeding for all teeth.
Through the insertion of a periodontal probe, the presence of bleeding on probing is signaled for 4 sites for each tooth.
A ratio is made between the bleeding sites and the total sites investigated to obtain a percentage value.
|
Four weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting glucose
Time Frame: Before T0
|
Measurement of blood glucose levels after fasting to assess glycemic status.
|
Before T0
|
|
Total cholesterol
Time Frame: Before T0
|
Measurement of total circulating cholesterol.
|
Before T0
|
|
High-Density Lipoprotein (HDL)
Time Frame: Before T0
|
Assessment of HDL cholesterol
|
Before T0
|
|
Low-Density Lipoprotein (LDL)
Time Frame: Before T0
|
Assessment of LDL cholesterol
|
Before T0
|
|
C-Reactive Protein (CRP)
Time Frame: Before T0
|
Systemic inflammatory biomarker used to evaluate inflammatory status
|
Before T0
|
|
Reactive Oxygen Metabolites (d-ROMs)
Time Frame: Before T0
|
Marker of oxidative stress reflecting circulating reactive oxygen metabolites
|
Before T0
|
|
Biological Antioxidant Potential (BAP)
Time Frame: Before T0
|
Measurement of antioxidant capacity in plasma
|
Before T0
|
|
Complete blood count (CBC)
Time Frame: Before T0
|
Hematological assessment including leukocytes, erythrocytes, hemoglobin, hematocrit, and platelet count.
|
Before T0
|
|
Systemic Immune-Inflammation Index (SII)
Time Frame: Before T0
|
Composite inflammatory index calculated as platelet count × neutrophil count / lymphocyte count.
|
Before T0
|
|
Body Mass Index (BMI)
Time Frame: Before T0
|
Anthropometric index calculated as weight (kg) divided by height squared (m²) to assess body composition.
|
Before T0
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michele Paolantonio, MD; DDS, University G. D'Annunzio Chieti-Pescara
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 11012023
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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