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

Primary Purpose

Periodontal Inflammation, Periodontal Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Vegan/vegetarian diet
Omnivorous diet
Sponsored by
G. d'Annunzio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Inflammation focused on measuring Experimental Gengivitis, Nutraceutical, Periodontal Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • G. D'Annunzio UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with a vegan/vegetarian diet

Patients with an omnivorous diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pocket Probing Depth
Change of the distance between the gingival margin and the depth of the probable site
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.
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.

Full Information

First Posted
January 23, 2023
Last Updated
May 16, 2023
Sponsor
G. d'Annunzio University
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1. Study Identification

Unique Protocol Identification Number
NCT05864768
Brief Title
The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study
Official Title
Experimental Gingivitis in Omnivores and Vegetarians/Vegans. The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
G. d'Annunzio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Inflammation, Periodontal Diseases
Keywords
Experimental Gengivitis, Nutraceutical, Periodontal Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with a vegan/vegetarian diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients with an omnivorous diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vegan/vegetarian diet
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omnivorous diet
Intervention Description
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 Outcome Measure Information:
Title
Eastman Interdental Bleeding Index
Description
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).
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Pocket Probing Depth
Description
Change of the distance between the gingival margin and the depth of the probable site
Time Frame
Four weeks
Title
Full Mouth Plaque Score
Description
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
Title
Full Mouth Bleeding Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Paolantonio, MD; DDS
Phone
+393395204073
Email
mpaolantonio@unich.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Paolantonio, MD; DDS
Organizational Affiliation
University G. D'Annunzio Chieti-Pescara
Official's Role
Principal Investigator
Facility Information:
Facility Name
G. D'Annunzio University
City
Chieti
State/Province
CH
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Paolantonio, MD; DDS
Phone
+393395204073
Email
mpaolantonio@unich.it

12. IPD Sharing Statement

Learn more about this trial

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

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