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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864768
• Other study ID #: 11012023
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: G. d'Annunzio University
• Contact: Michele Paolantonio, MD; DDS
• Phone: +393395204073
• Email: mpaolantonio[@]unich.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Periodontal Diseases
• Periodontal Inflammation

Intervention

Dietary Supplement:
• Vegan/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.
• Omnivorous 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.

Locations

Country	Name	City	State
Italy	G. D'Annunzio University	Chieti	CH

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pocket Probing Depth	Change of the distance between the gingival margin and the depth of the probable site	Four weeks
Secondary	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
Secondary	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