CClinicalTrials.gg
CompletedNCT05864768Updated May 28, 2026

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

An interventional study of Vegan/vegetarian diet and Omnivorous diet in Periodontal Inflammation and Periodontal Diseases, sponsored by G. d'Annunzio University. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by G. d'Annunzio University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Periodontal Inflammation
  • Periodontal Diseases

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Keywords

  • Experimental Gengivitis
  • Nutraceutical
  • Periodontal Inflammation
03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 36 is below the median of 45 across 530 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

G. d'Annunzio University is the lead sponsor of 62 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
36 participants (actual)

Study arms

  • 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.

    Dietary Supplement: Vegan/vegetarian diet

  • 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.

    Dietary Supplement: Omnivorous diet

Interventions

  • Dietary supplementVegan/vegetarian diet

    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.

  • Dietary supplementOmnivorous diet

    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.

06

What researchers measure

Primary outcomes

  1. Eastman Interdental Bleeding Index

    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).

    Time frame: Four weeks

Secondary outcomes

  1. 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.

    Time frame: Four weeks

  2. 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.

    Time frame: Four weeks

Other outcomes

  1. Fasting glucose

    Measurement of blood glucose levels after fasting to assess glycemic status.

    Time frame: Before T0

  2. Total cholesterol

    Measurement of total circulating cholesterol.

    Time frame: Before T0

  3. High-Density Lipoprotein (HDL)

    Assessment of HDL cholesterol

    Time frame: Before T0

  4. Low-Density Lipoprotein (LDL)

    Assessment of LDL cholesterol

    Time frame: Before T0

  5. C-Reactive Protein (CRP)

    Systemic inflammatory biomarker used to evaluate inflammatory status

    Time frame: Before T0

  6. Reactive Oxygen Metabolites (d-ROMs)

    Marker of oxidative stress reflecting circulating reactive oxygen metabolites

    Time frame: Before T0

  7. Biological Antioxidant Potential (BAP)

    Measurement of antioxidant capacity in plasma

    Time frame: Before T0

  8. Complete blood count (CBC)

    Hematological assessment including leukocytes, erythrocytes, hemoglobin, hematocrit, and platelet count.

    Time frame: Before T0

  9. Systemic Immune-Inflammation Index (SII)

    Composite inflammatory index calculated as platelet count × neutrophil count / lymphocyte count.

    Time frame: Before T0

  10. Body Mass Index (BMI)

    Anthropometric index calculated as weight (kg) divided by height squared (m²) to assess body composition.

    Time frame: Before T0

07

Study locations

1 site
  • G. D'Annunzio University
    Chieti, CH 66100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05864768
Lead sponsor
G. d'Annunzio University
Responsible party
Michele Paolantonio (Full Time Professor, G. d'Annunzio University) — Principal investigator
First posted
May 18, 2023
Start date
Feb 16, 2023
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025
Last update
May 28, 2026

Study contacts

Michele Paolantonio, MD; DDS
principal investigator · University G. D'Annunzio Chieti-Pescara

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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