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

NCT05864768 | Recruiting

• 1 other identifier: 11012023
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Periodontal Inflammation; Periodontal Diseases

Keywords

Experimental Gengivitis; Nutraceutical; Periodontal Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pocket Probing Depth

  Four weeks

• Full Mouth Plaque Score

  Four weeks

• Full Mouth Bleeding Score

  Four weeks

Study Arms (2)

Patients with a vegan/vegetarian diet

EXPERIMENTAL

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

Patients with an omnivorous diet

ACTIVE COMPARATOR

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

Interventions

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.

Patients with a vegan/vegetarian diet

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.

Patients with an omnivorous diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

G. D'Annunzio University

Chieti, CH, 66100, Italy

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Diet, Vegan; Diet, Vegetarian

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Michele Paolantonio, MD; DDS

  University G. D'Annunzio Chieti-Pescara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Paolantonio, MD; DDS

CONTACT

+393395204073; mpaolantonio@unich.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Time Professor

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: May 18, 2023
• Study Start: April 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

IT (1)