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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorUniversity of Guadalajara

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Trauma-Induced Gingival Recessions

Cervical caries

History of bleeding diathesis

Pregnant or nursing women

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
10 weeks, 6 and 12 months
2

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.

Time frame
10 weeks, 6 and 12 months
3

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.

Time frame
10 weeks, 6 and 12 months
4

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

Time frame
10 weeks, 6 and 12 months

Secondary outcomes

1

Probing depth (PD)

The periodontal probe is inserted along the root surface of the tooth in order to measure the distance from gingival margin to pocket bottom of the periodontal pocket. The values are measured in mm, six sites per tooth, measurements are expressed as averages.

Time frame
10 weeks
2

Clinical attachment level (CAL)

The clinical attachment level provides an estimation of the true periodontal support and is used for monitoring changes in periodontal support over the time. The "Attachment Level" for each site will be calculated based on the following formula: probing depth (mm) less gingival margin (mm) if the cemento-enamel junction (CEJ) is cover to the gingival margin. In situation where the gingival margin is apical to the CEJ, probing depth (mm) sum the distance to CEJ at gingival margin (mm). The values are measured in mm, six sites per tooth for each teeth present in the mouth, measurements are expressed as averages.

Time frame
10 weeks
3

Bleeding on probing (BP)

The periodontal probe is carefully introduced to the bottom of the pocket and gently moved laterally around the tooth, six points are recorded for each tooth as bleeding present or absent, the measurements are expressed as percentage of bleeding on probing of teeth present in the mouth. The bleeding in each tooth is identified and the values obtained are used to average the bleeding.

Time frame
10 weeks
4

Plaque or calculus (PoC)

The presence of plaque and calculus is evaluated and marked as present or absent on the periodontal chart based on 6 points on the tooth, the measurements are expressed as percentage of plaque or calculus (PoC).

Time frame
10 weeks

Other outcomes

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