The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study

Study Overview
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Brief Summary
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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 our controlled study is to understand whether a vegetarian/vegan diet can be considered as protective for periodontal health compared to an omnivorous diet. For this purpose, we used a test group of 22 omnivorous subjects and a control group of 22 vegetarian/vegan patients in which experimental gingivitis was induced.

Official Title
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Experimental Gingivitis in Omnivores and Vegetarians/Vegans. The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study

Conditions
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Periodontal Inflammation, Periodontal Diseases

Intervention / Treatment
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* Dietary Supplement: Vegan/vegetarian diet
* Dietary Supplement: Omnivorous diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Optimal systemic health conditions Non-Smoking Absence of cardio-vascular pathologies Absence of pulmonary pathologies Non-diabetic Not pregnant FMPS <20% FMBS <20% Omnivorous or vegan/vegetarian 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% FMBS>20% 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with a vegan/vegetarian diet<br>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). The use of antiseptics (chlorhexidine mouthwash 0.20%) was prescribed twice a day for 15 days. After 15 days from baseline (T0) all patients were recorded the parameters of FMPS, FMBS, PPD 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. | Dietary Supplement: Vegan/vegetarian diet<br>* 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.<br>|
| Active Comparator: Patients with an omnivorous diet<br>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). The use of antiseptics (chlorhexidine mouthwash 0.20%) was prescribed twice a day for 15 days. After 15 days from baseline (T0) all patients were recorded the parameters of FMPS, FMBS, PPD 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. | Dietary Supplement: Omnivorous diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eastman Interdental Bleeding Index | A wooden wedge is inserted buccally into the interdental space 2-3 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 |
| --- | --- | --- |
| Pocket Probing Depth | Change of the distance between the gingival margin and the depth of the probable site | Four weeks | 
| Full Mouth Plaque Score | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Experimental Gengivitis, Nutraceutical, Periodontal Inflammation