An observational study in Periodontitis, Cardiovascular Risk Factor and Metabolic Risk Factors, sponsored by Universidad Rey Juan Carlos. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Universidad Rey Juan Carlos · Observational
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 61 is below the median of 90 across 428 observational studies indexed under Periodontitis.
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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.
Exclusion Criteria:
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.
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.
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.
Time frame: Day 1
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.
Time frame: Day 1
Weight
Body weight was assessed using a digital weight scale (Insmart; Hanoi, Vietnam; FG260) with a precision of 50 g and expressed in kg.
Time frame: Day 1
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.
Time frame: Day 1
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).
Time frame: Day 1
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).
Time frame: Day 1
Height
Height was measured in cm with a portable stadiometer (Seca Corp.; Berlin, Germany; CE 0123) with a 0.1cm precision.
Time frame: Day 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).
Time frame: Day 1
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.
Time frame: Day 1
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)).
Time frame: Day 1
Sex
Male/female. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.
Time frame: Day 1
Age (y)
Age in years. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.
Time frame: Day 1
Type of tootbrush
Manual/electric. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.
Time frame: Day 1
Teeth brushing per day
Number of times. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.
Time frame: Day 1
Other ongoing pathologies
Name of the pathology. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.
Time frame: Day 1
Medication
Medications being used. Correlations between periodontal status, physical activity and anthropometric measurements will be analyzed.
Time frame: Day 1
Smoker
Yes/No
Time frame: Day 1
Plan to share: Undecided — Yes, individual participant data that underlie the results reported in this article, after de-identification, may be shared.
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Universidad Rey Juan Carlos