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Completed

NCT Number: NCT05864768

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.

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Key information

Conditions

Periodontal Inflammation Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

G. D'Annunzio University

Chieti, CH, 66100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vegan/vegetarian diet

Dietary Supplement

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.

Omnivorous diet

Dietary Supplement

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Fasting glucose

    Time frame: Before T0

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

  2. Total cholesterol

    Time frame: Before T0

    Measurement of total circulating cholesterol.

  3. High-Density Lipoprotein (HDL)

    Time frame: Before T0

    Assessment of HDL cholesterol

  4. Low-Density Lipoprotein (LDL)

    Time frame: Before T0

    Assessment of LDL cholesterol

  5. C-Reactive Protein (CRP)

    Time frame: Before T0

    Systemic inflammatory biomarker used to evaluate inflammatory status

  6. Reactive Oxygen Metabolites (d-ROMs)

    Time frame: Before T0

    Marker of oxidative stress reflecting circulating reactive oxygen metabolites

  7. Biological Antioxidant Potential (BAP)

    Time frame: Before T0

    Measurement of antioxidant capacity in plasma

  8. Complete blood count (CBC)

    Time frame: Before T0

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

  9. Systemic Immune-Inflammation Index (SII)

    Time frame: Before T0

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

  10. Body Mass Index (BMI)

    Time frame: Before T0

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

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 18, 2023
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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