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

May 25, 2026 updated by: Michele Paolantonio, G. d'Annunzio University

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

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • CH
      • Chieti, CH, Italy, 66100
        • G. d'Annunzio University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michele Paolantonio, MD; DDS, University G. D'Annunzio Chieti-Pescara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2023

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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