Relationship Between Nutritional Status, Physical Activity and Periodontal Status (NAP-Perio)

March 22, 2026 updated by: Miguel Ángel Martínez García, Universidad Rey Juan Carlos

Association of Markers of Physical Fitness in the Prevalence and Severity of Periodontal Disease and Its Management

This observational retrospective study aims to evaluate the relationship between nutritional status, physical activity levels, and periodontal health in adult patients. The project represents a second analytical phase of a previously conducted study (2021-2022), in which gingival crevicular fluid samples were collected solely for LL-37 analysis (NCT04404335). The biochemical component was completed and published independently (doi: 10.1186/s12903-023-03023-w) and will not be incorporated into the present analysis.

In this newly proposed phase, the research team will review patients' clinical and dental records and analyze previously collected lifestyle, anthropometric, and periodontal data. Participants completed standardized health questionnaires on medical history, oral hygiene habits, dietary patterns, and lifestyle. They also completed a validated physical activity questionnaire over the course of one week. At their clinical visit, they underwent a full oral and periodontal examination, and anthropometric assessments including BMI, waist circumference, and body composition.

The objective is to determine how nutritional status and physical activity relate to periodontal health using data collected during routine clinical evaluation and standardized assessments. This retrospective analysis may provide insight into lifestyle-related factors contributing to periodontal disease risk and severity. The study received ethics committee approval (Ref.: 1003202109021) prior to any data collection, although the retrospective analysis of clinical records had not been conducted or registered until now.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This retrospective observational study investigates the relationship between nutritional status, physical activity, and periodontal health in adult patients. It represents the second analytical phase of a broader project conducted at the University Clinic of Universidad Rey Juan Carlos. The initial phase (2021-2022) involved the collection of gingival crevicular fluid samples for quantification of the antimicrobial peptide LL-37. That biochemical analysis was registered and published separately and will not be incorporated into the present study. Instead, the current phase focuses exclusively on clinical, anthropometric, and lifestyle-related variables.

The aim of this phase is to analyze previously collected data to identify potential associations between periodontal status and indicators of physical activity and nutritional condition. The analysis is retrospective, based on patient records and datasets gathered during standard clinical procedures and validated questionnaires. The approved retention period for personal data was five years, allowing for the current review.

Participants completed a comprehensive health questionnaire routinely used at the University Clinic. This instrument collects detailed information regarding systemic diseases, medications, oral hygiene behaviors, dietary habits, and lifestyle. A validated physical activity questionnaire was administered, to be completed over the course of one week.

A full oral and periodontal examination was performed following standardized clinical diagnostic criteria. Measurements included plaque levels, probing depths, clinical attachment loss, bleeding on probing, and other conventional periodontal parameters, allowing for determination of periodontal disease presence and grading.

Anthropometric and functional assessments were also carried out. Height, weight, and waist circumference were measured to calculate body mass index and evaluate central adiposity. Body composition was assessed using a specialized bioimpedance scale capable of estimating fat mass, body water, and muscle mass.

Although gingival crevicular fluid samples had been collected during the original study, these biochemical data will not be integrated into the present analysis. The focus of this retrospective study is exclusively on clinical periodontal outcomes and their potential association with lifestyle-related variables, anthropometric indicators, and physical activity measures.

The dataset compiled during the earlier phase provides a unique opportunity to explore interactions among nutritional status, physical activity, functional strength, and periodontal disease. By reviewing and analyzing these previously collected variables, the study aims to generate evidence that may inform preventive strategies, risk stratification, and holistic approaches to managing periodontal health in relation to systemic well-being.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • University Clinic, Universidad Rey Juan Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients who attended the University Clinic of Universidad Rey Juan Carlos between 2021 and 2022 for routine dental care. All participants completed standardized health, lifestyle, and physical activity questionnaires, and underwent a comprehensive oral and periodontal examination as part of their clinical visit. Anthropometric assessments were also performed during this visit. The study population represents a convenience sample of individuals seeking routine dental services, and no random sampling procedures were applied.

Description

Inclusion Criteria:

  • age 18 or over
  • no previous history of periodontal treatment in the last 6 months
  • no medical or dental history that could contraindicate periodontal treatment

Exclusion Criteria:

  • current pregnancy or lactation
  • immunological disorders
  • periodontal treatment within the last 6 months
  • oral contraception or antibiotic usage within the last 3 months
  • infections (such as HIV, hepatitis or tuberculosis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Healthy
Periodontitis Stage I-II
Initial (Stage I) or mild (Stage II) periodontitis with interdental CAL of 1-4 mm, PD ≤5 mm, and bone loss affecting the coronal third (<33%), with no tooth loss.
Periodontitis Stage III-IV
Moderate (Stage III) or severe (Stage IV) periodontitis with CAL ≥5 mm, PD ≥6 mm, bone loss extending from the coronal to the middle third (33-66%) or to the apical third (>66%), and loss of fewer than four teeth up to more than five teeth, with or without loss of masticatory function.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Periodontal status
Time Frame: Day 1
Based on the clinical and radiographic evaluation, the participants were distributed into the healthy, Stage I-II, and Stage III-IV periodontitis groups. Periodontitis patients were defined as patients presenting gingival inflammation with clinical attachment loss/bone loss, according to the 2018 Classification of Periodontal and Peri-implant Diseases and Conditions. After concluding a diagnosis for periodontitis, a stage was assigned based on the degree of clinical attachmentloss (CAL) and radiographic bone loss (RBL) (1-2 mm or 3-4 mm CAL for Stage I or II and ≥ 5 mm for Stage III-IV). Healthy subjects were defined as: no sites with interdental attachment loss, PD = 1-3 mm and BOP < 10% (Madruga et al. BMC Oral Health 2023;23:335). The higher the stage, the more severe the periodontitis.
Day 1
Total MET (IPAQ score)
Time Frame: Day 1
Physical activity level of participants was determined by means of the International physical activity questionnaire short form (IPAQ-SF), consisting of 7 questions (J Sports Med Phys Fitness 2016;56(10):1139-1146).Total Metabolic Equivalent of Task (MET) minutes per week will be calculated based on the scoring protocol. The higher the value, the more active. Participants completed the questionnaire on-site.
Day 1
Weight
Time Frame: Day 1
Body weight was assessed using a digital weight scale (Insmart; Hanoi, Vietnam; FG260) with a precision of 50 g and expressed in kg.
Day 1
Bioimpedance (% FM)
Time Frame: Day 1
The estimated % body fat mass (%FM) value measured by means of a manual Bioelectrical Impedance Analysis (BIA) bipolar analyzer (Omron Corporation; Kyoto, Japan; BF306) will be used to compare the results of body composition obtained by anthropometry and by BIA as previously described (Lizana Arze et al., Int. J. Morphol 2011;29(4)_1364-1369). Briefly, manual bioimpedance devices work through the emission of low electrical currents (5KHz, 500mA). Body fluids and electrolytes are responsible for conductance, and cell membranes produce capacitance. Because adipose tissue is less hydrated than lean body tissue, more adipose tissue results in a smaller conducting volume or path for current and larger impedance to current passage.
Day 1
Waist circumference
Time Frame: Day 1
Waist circumference (WC) in cm was measured midway between the lower margin of the last rib and the anterior and superior iliac spine. Consequently, the waist-height ratio (WHtR) will be calculated as WC(cm)/height(cm).
Day 1
Hip circumference
Time Frame: Day 1
Hip circumference (HC) in cm was measured around the pelvis at the point of maximum protusion of the buttcocks and the waist-hip ratio (WHR) will then be calculated according to the formula WC(cm)/HC(cm).
Day 1
Height
Time Frame: Day 1
Height was measured in cm with a portable stadiometer (Seca Corp.; Berlin, Germany; CE 0123) with a 0.1cm precision.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI)
Time Frame: Day 1
Body mass index (BMI) will be calculated as (Wt (kg))/(Ht (m^2)), as an index of general adiposity and cardiometabolic risk factor (high for individuals with overweight and obesity). BMI will be categorized as obese (≥ 30 kg/m²), overweight (25-29.9 kg/m²), or normal weight (< 25 kg/m²).
Day 1
Cardiometabolic risk factors
Time Frame: Day 1
Increased risks of cardiometabolic morbidity will be defined as waist circumference (WC) ≥ 102 cm for men and ≥ 88 cm for women. Central obesity will be defined using a waist height ratio (WHtR = WC (cm)/height (cm)) cut-off point for high cardiovascular risk of > 0.50 for individuals <50 years and >0.6 for those >50 years, and waist-hip ratio (WHR = WC (cm)/HC(cm)) cut-offs of ≥ 1.00 for men and ≥ 0.85 for women. For % body fat mass (%FM), obesity will be defined as > 25% for men and > 35% for women, while overweight will be 20-25% and 30-35%, respectively.
Day 1
Other cardiovascular risk factors
Time Frame: Day 1
Other indices will be subject to calculation as better indices of cardiovascular risk, and abdominal and gluteofemoral adiposity. The higher the values, the greater the adiposity and risk factor. Conicity index (CONI) calculated as (WC (m))/(0.109√((Wt (kg))/(Ht (m)))), body shape index (ABSI) calculated as (1000×(WC(m)×Wt(kg) )_^(-2/3)-(Ht(m)^(5/6) )); abdominal volume index (AVI) calculated as ((2×((WC(cm) )^2+(0.7×(WC(cm)-HC(cm) )^2))/1000; body roundness index (BRI) calculated as 364.2-365.5×√(1 - [WC/2π]2/[0.5×Ht2]); estimated Total Body Fat (eTBF) calculated as 100 * (-Z + A - B)/C, where A = (4.15*WC*39.3701), B = (0.082*Wt*2.20462), C = (Wt*2.20462), Z = 98.42 (men), Z = 76.76 (women); relative fat mass (RFM) calculated as 64 - (20*Ht/WC) + (12*S), where S = 0 (men), S = 1 (women); Hip Index (HI) calculated as HC * Wt -0.482*Ht0.310; Weight-adjusted Waist Index (WWI) calculated as (WC (m)×100)/(√Wt(kg)).
Day 1
Sex
Time Frame: Day 1
Male/female. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.
Day 1
Age (y)
Time Frame: Day 1
Age in years. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.
Day 1
Type of tootbrush
Time Frame: Day 1
Manual/electric. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.
Day 1
Teeth brushing per day
Time Frame: Day 1
Number of times. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.
Day 1
Other ongoing pathologies
Time Frame: Day 1
Name of the pathology. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.
Day 1
Medication
Time Frame: Day 1
Medications being used. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.
Day 1
Smoker
Time Frame: Day 1
Yes/No
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Rey Juan Carlos

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universita degli Studi di Catania
Middlesex University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Madruga González, DDS, PhD, Universidad Rey Juan Carlos
  • Principal Investigator: Miguel Ángel Martínez García, BSc, MSc, PhD, Universidad Rey Juan Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1003202109021
  • ENM167/192004202112821 (Other Identifier: Universidad Rey Juan Carlos)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Yes, individual participant data that underlie the results reported in this article, after de-identification, may be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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