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

Sponsor
G. d'Annunzio University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05864768
Collaborator
(none)
44
1
2
3.9
11.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vegan/vegetarian diet
  • Dietary Supplement: Omnivorous diet
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Experimental Gingivitis in Omnivores and Vegetarians/Vegans. The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with a vegan/vegetarian 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). 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
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). 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
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.

Outcome Measures

Primary Outcome Measures

  1. Eastman Interdental Bleeding Index [Four weeks]

    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).

Secondary Outcome Measures

  1. Pocket Probing Depth [Four weeks]

    Change of the distance between the gingival margin and the depth of the probable site

  2. Full Mouth Plaque Score [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.

  3. Full Mouth Bleeding Score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 G. D'Annunzio University Chieti CH Italy 66100

Sponsors and Collaborators

  • G. d'Annunzio University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michele Paolantonio, Full Time Professor, G. d'Annunzio University
ClinicalTrials.gov Identifier:
NCT05864768
Other Study ID Numbers:
  • 11012023
First Posted:
May 18, 2023
Last Update Posted:
May 18, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michele Paolantonio, Full Time Professor, G. d'Annunzio University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2023