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PeriodontitisNAP-PerioNCT07496710

Relationship Between Nutritional Status, Physical Activity and Periodontal Status

An observational study of Periodontitis and Cardiovascular Risk Factor, run by Universidad Rey Juan Carlos at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Type of treatment
Injection or infusion
How many people
61 participants
Where
1 siteSpain
Study dates
3 Nov 2021to 30 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University Clinic, Universidad Rey Juan Carlos

    Alcorcón, Madrid, 28922

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Keywords
Periodontitis, International Physical Activity Questionnaire, Cardiovascular Risk, Metabolic Risk, Anthropometric Measurements, Waist-to-Hip Ratio, Waist-to-Height Ratio, Body Mass Index
Medical subject headings
Periodontitis, Motor Activity, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07496710
Study groupRoleWhat they receive
HealthyNot described
Periodontitis Stage I-IIInitial (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-IVModerate (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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Periodontal status

    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.

    Measured: Day 1

  2. Total MET (IPAQ score)

    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.

    Measured: Day 1

  3. Weight

    Body weight was assessed using a digital weight scale (Insmart; Hanoi, Vietnam; FG260) with a precision of 50 g and expressed in kg.

    Measured: Day 1

  4. Bioimpedance (% FM)

    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.

    Measured: Day 1

  5. Waist circumference

    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).

    Measured: Day 1

  6. Hip circumference

    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).

    Measured: Day 1

  7. Height

    Height was measured in cm with a portable stadiometer (Seca Corp.; Berlin, Germany; CE 0123) with a 0.1cm precision.

    Measured: Day 1

Secondary outcomes (10)

  1. Body Mass Index (BMI)

    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).

    Measured: Day 1

  2. Cardiometabolic risk factors

    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.

    Measured: Day 1

  3. Other cardiovascular risk factors

    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)).

    Measured: Day 1

  4. Sex

    Male/female. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.

    Measured: Day 1

  5. Age (y)

    Age in years. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.

    Measured: Day 1

  6. Type of tootbrush

    Manual/electric. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.

    Measured: Day 1

  7. Teeth brushing per day

    Number of times. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.

    Measured: Day 1

  8. Other ongoing pathologies

    Name of the pathology. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.

    Measured: Day 1

  9. Medication

    Medications being used. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.

    Measured: Day 1

  10. Smoker

    Yes/No

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start3 Nov 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07496710
Sponsor's protocol ID
1003202109021
Other IDs
ENM167/192004202112821
Acronym
NAP-Perio
Status last verified
Mar 2026
First submitted
15 Mar 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Yes, individual participant data that underlie the results reported in this article, after de-identification, may be shared.

Publications

  • Shimazaki Y, Egami Y, Matsubara T, Koike G, Akifusa S, Jingu S, Yamashita Y. Relationship between obesity and physical fitness and periodontitis. J Periodontol. 2010 Aug;81(8):1124-31. doi: 10.1902/jop.2010.100017.

    PubMed 20476888

  • Serrano, M.D.M., de Espinosa, M.G.M., Zamorano, E.M. Relationship between physical measures of anthropometry and bioimpedance measures. In: Preedy, V.R. (ed.). Handbook of Anthropometry. Physical measures of human form in health and disease. Springer: New York, USA; 2012. pp. 459-73. doi: 10.1007/978-1-4419-1788-1_25.

  • Browning LM, Hsieh SD, Ashwell M. A systematic review of waist-to-height ratio as a screening tool for the prediction of cardiovascular disease and diabetes: 0.5 could be a suitable global boundary value. Nutr Res Rev. 2010 Dec;23(2):247-69. doi: 10.1017/S0954422410000144. Epub 2010 Sep 7.

    PubMed 20819243

  • Lizana Arce, P.J., Almagià Flores, A.A., Simpson Lelievre, M.C., Olivares Barraza R., Binvignat Gutiérrez, O., Ivanovic Marincovich, D. & Berral de la Rosa, F.J. Inconsistency between the body fat percentages estimated through anthropometric measurements and manual bioimpedance in children and adolescents. Int. J. Morphol. 29(4), 1364-1369 (2011). doi: 10.4067/S0717-95022011000400049.

  • Chapple IL, Genco R; working group 2 of the joint EFP/AAP workshop. Diabetes and periodontal diseases: consensus report of the Joint EFP/AAP Workshop on Periodontitis and Systemic Diseases. J Periodontol. 2013 Apr;84(4 Suppl):S106-12. doi: 10.1902/jop.2013.1340011.

    PubMed 23631572

  • Madruga D, Garcia MM, Martino L, Hassan H, Elayat G, Ghali L, Ceballos L. Positive correlational shift between crevicular antimicrobial peptide LL-37, pain and periodontal status following non-surgical periodontal therapy. A pilot study. BMC Oral Health. 2023 May 28;23(1):335. doi: 10.1186/s12903-023-03023-w.

    PubMed 37246231

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontitis and Cardiovascular Risk Factor, run by Universidad Rey Juan Carlos at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Periodontal status (time frame: Day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07496710, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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