Intake of Nitrate-rich Vegetables and Their Effect on Inflammatory Molecules and Oral Microbiota of Patients With Periodontitis

NCT05232331 | Recruiting

• 1 other identifier: CI-02721
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Vegetables, mainly green leafy ones and some others like beets, are a rich source of nitrate. Nitrate metabolism has shown benefits to the body and there are recent studies that agree that the consumption of nitrates from vegetables can modify the oral microbiota by increasing species with nitrate-reducing capacity, which are also bacteria that are associated with oral health.

Conditions

Periodontal Diseases; Periodontitis

Keywords

Nitrates; Vegetables; Oral Microbiota; Periodontitis; Inflammatory molecules

Outcome Measures

Primary Outcomes (5)

• Composition of the oral microbiota

  The composition of the oral microbiota will be before and after the intervention will be evaluated in both study groups using 16S rRNA gene Illumina sequencing. For their analysis, alpha diversity will be evaluated: richness using the Chao1 index and diversity using the Shannon index; beta diversity with PCoA (principal coordinates analysis). In addition, taxonomic assignment will be performed with the DADA2 protocol at both genus and species (ASVs) level, against the SILVA database.

  10 weeks, 6 and 12 months

• Evaluation of nitrate-reducing capacity

  The nitrate-reducing capacity in the mouth will be evaluated before and after the intervention in both study groups. Nitrite and nitrate levels will be quantified in saliva and in a nitrate reduction test. Test strips will be used and measured in a Merck reflectometer, which will provide the mg/L of each metabolite.

  10 weeks, 6 and 12 months

• Dietary intake of nitrate

  Three 24-hour diet recall will be performed and the average nitrate intake in g/day will be evaluated. Tables reporting the average amount of nitrate in food will be used and multiplied by the reported amount of food consumed by the participant.

  10 weeks, 6 and 12 months

• Periodontal chart evaluation

  Periodontal chart is a tool used by dental professionals to evaluate different parameters such as probing depth, clinical attachment level (CAL), bleeding on probing (BP), plaque or calculus (PoC), which help to identify the condition of the periodontal tissues and determine the status of the disease. The measurement of these parameters may give an indication of the extent and severity of the periodontal disease, a Hu Friedy periodontal probe is used for the evaluation, each tooth is divided into six points for study in the vestibular or lingual and palatal aspect, mesial, central and distal. A periodontist will perform the periodontal chart before and after the intervention in both study groups. The online periodontogram of the Spanish Society of Periodontology and Osseointegration (SEPA) will be used: http://sepa.es/periodontograma/index.html

  10 weeks, 6 and 12 months

• Determination of salivary inflammatory molecules

  To obtain the saliva sample, the patient will be provided with a sterile 15 ml tube to deposit the accumulated saliva for 5 minutes, this time will be to obtain the largest possible amount of saliva. The saliva sample will not be stimulated (drooling or salivating). Once 3 ml are obtained, the donation will be finished. The saliva will be handled in a sterile area, 40 µl of metalloproteinase inhibitor will be added for each milliliter of saliva to avoid degradation of the molecules of interest, then it will be centrifuged at 4°C at 3,500 rpm for 10 minutes and, once the centrifugation is finished, 250 µl will be aliquoted in 1.5 ml microtubes (a total of 4 tubes) for the determination of the molecules with ELISA kit.

  10 weeks, 6 and 12 months

Secondary Outcomes (4)

• Probing depth (PD)

  10 weeks

• Clinical attachment level (CAL)

  10 weeks

• Bleeding on probing (BP)

  10 weeks

• Plaque or calculus (PoC)

  10 weeks

Study Arms (2)

Control

NO INTERVENTION

This group will receive non-surgical periodontal treatment, however they will not receive any modification to their diet

Intervention

EXPERIMENTAL

This group will receive non-surgical periodontal treatment, and also as a treatment of interest, will receive the indication to consume \~ 350 mg of nitrate from vegetables, as well as an accompaniment to achieve this objective.

Dietary Supplement: Intake of nitrate rich vegetables

Interventions

Intake of nitrate rich vegetables DIETARY_SUPPLEMENT

Nutritional intervention for 10 weeks to increase the consumption of vegetables rich in nitrate. At the beginning of the NSPT on visit 1 (week 2), the first of 5 nutritional interventions will begin with the objective of consuming \~ 350 mg of nitrate daily from vegetables

Intervention

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and/or women from 30 to 65 years old
• Voluntary participation and signing the written informed consent
• Not receiving nutritional treatment at the time of uptake
• Availability to attend all scheduled visits
• Have an indication to receive nonsurgical periodontal treatment (NSPT)
• Interdental clinical insertion loss ≥3mm and ≥5mm in the buccal or oral area of two or more non-adjacent teeth
• Detectable depths ≥ 5mm in two or more teeth
• Radiographic evidence of periodontal bone loss

You may not qualify if:

• Trauma-Induced Gingival Recessions
• Cervical caries
• History of bleeding diathesis
• Pregnant or nursing women
• BMI \<18.5 kg / m2
• History of any of the following self-reported diseases: type 2 diabetes mellitus, high blood pressure, kidney or liver disease, inflammatory bowel diseases, autoimmune diseases and/ or use of medications to control these diseases.
• Having or presenting a high risk of infection by tuberculosis, hepatitis B or Human Immunodeficiency Virus (HIV)
• Use of antibiotics (including antibiotic oral rinse) 6 months prior to or during the study
• Having received specialized periodontal treatment in the previous 6 months.
• Smoking habit
• Require an interpreter or not understand Spanish to attend or provide written material.

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Integral Dental Clinics CUCS UDG

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Lucrecia Carrera, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucrecia Carrera, PhD

CONTACT

+523310585200; lucrecia.carrera@academicos.udg.mx

Nydia S Sanchez, Bachelor

CONTACT

+523311777088; nydia.sanchez0207@alumnos.udg.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Single blind. Dentists in charge of assessing dental clinical parameters, as well as researchers performing the analysis of the oral microbiota, will be unaware of the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: February 9, 2022
• Study Start: June 23, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

ME (1)