NCT07496710

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 15, 2026

Last Update Submit

March 22, 2026

Conditions

Keywords

PeriodontitisInternational Physical Activity QuestionnaireCardiovascular RiskMetabolic RiskAnthropometric MeasurementsWaist-to-Hip RatioWaist-to-Height RatioBody Mass Index

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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).

    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).

    Day 1

  • Height

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

    Day 1

Secondary Outcomes (10)

  • Body Mass Index (BMI)

    Day 1

  • Cardiometabolic risk factors

    Day 1

  • Other cardiovascular risk factors

    Day 1

  • Sex

    Day 1

  • Age (y)

    Day 1

  • +5 more secondary outcomes

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic, Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (6)

  • 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.

    PMID: 20476888BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 20819243BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 23631572BACKGROUND
  • 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.

MeSH Terms

Conditions

PeriodontitisMotor ActivityOverweightObesity

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Madruga González, DDS, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR
  • Miguel Ángel Martínez García, BSc, MSc, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 15, 2026

First Posted

March 27, 2026

Study Start

November 3, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations