Effect of Non-chirurgical Periodontal Treatment on the Immune System From a Gender Perspective

NCT06261723 | Completed

• 1 other identifier: PI22/1009
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to evaluate non-surgical periodontal treatment in women and men with periodontitis with and without obesity. The main questions it aims to answer are:

• If non-surgical periodontal treatment of patients with chronic periodontitis can modulate the innate and adaptive immune response taking into account patient gender and the coexistence of obesity
• If there are specific miRNAs that can regulate this immune response and can be considered as suitable biomarkers and therapeutic targets. Obese or non-obese participants with periodontitis will receive non-surgical periodontal treatment, consisting of oral health guidance and mechanical periodontal debridement throughout the mouth using an ultrasonic device and manual curettes. Researchers will compare four groups: obese women, non-obese women, obese men, and non-obese men, to clarify the involment of immune response after treatment, considering the coexistence of obesity and potential gender differences.

Conditions

Periodontal Diseases

Keywords

inflammation; atherosclerosis; gingivitis; oxidative stress; Obesity

Outcome Measures

Primary Outcomes (9)

• Changes in inflammasome complex activation grade in patients with chronic periodontitis with and without obesity, before and after non-surgical periodontal treatment.

  Relative protein expression of NLRP3, ASC, Caspase-1, AIM2, IL-1β, IL-18 and inflammatory mediators NFκB, JNK, IL6, and TNFα by Western Blot and normalized to the loading control protein, and inflammasome assembly by confocal microscopy in PBMC.

  At recruitment

• Changes in endothelial function in the study population.

  Evaluation of leucocytes adhesion to the endothelial cell in vitro by means of a parallel flow chamber system coupled to an inverted phase-contrast microscope.

  At recruitment

• Changes in endothelial function at molecular level in the study population.

  Evaluation of circulating levels of adhesion molecules - P-selectin, ICAM-1, and VCAM-1, and circulating cytokines (L1β, IL18, IL6 and TNFα) in serum using Luminex technique.

  At recruitment

• Changes in the systemic inflammation status in the study population.

  Evaluation of circulating levels of mtDNA in plasma samples using RT-PCR.

  At recruitment

• Changes in the expression of genes related to inflammatory pathways in PBMC in the study population.

  Relative expression of genes related to inflammatory pathways (TLR and NFkB) by means of nanostring technology.

  At recruitment

• Changes in the expression of genes related to oxidative stress levels in PBMC in the study population.

  Relative expression of genes related to oxidative stress (GSR, GPX1, GPX2, SOD, CAT, TXNRD1, AKR1B10, SLC7A11, GCLC, GCLM) by means of nanostring technology.

  At recruitment

• Changes in the expression of genes related to cellular respiration in PBMC in the study population.

  Relative expression of genes related to mitochondrial respiration (I, II, III, IV and V complexes) in PBMC by means of nanostring technology

  At recruitment

• Sequence miRNAs in biological fluids in patients with chronic periodontitis with and without obesity, before and after non-surgical periodontal treatment.

  Analysis of differential gen expression (DEGs) of miRNAs

  At recruitment

• Evaluate the distribution and phenotype of different T lymphocyte and monocyte subpopulations in the study population.

  Detection of T lymphocyte subpopulations with CD3/CD4/CD8/CD45RA/CCR7/CD38 multicolor panel and monocyte subpopulations with CD14/CD16 multicolor panel by flux cytometry.

  At recruitment

Secondary Outcomes (3)

• Changes in the protein expression of autophagy markers in PBMC in the study population.

  At recruitment

• Evaluate autophagy flux in the study population.

  At recruitment

• Evaluate autophagosome formation in the study population.

  At recruitment

Study Arms (2)

Control Group without obesity

Control Group with periodontitis and without obesity

Procedure: non-chirurgical periodontal treatment

Obesity Group

Obesity Group with periodontitis

Procedure: non-chirurgical periodontal treatment

Interventions

non-chirurgical periodontal treatment PROCEDURE

The non-chirurgical periodontal treatment (scaling and root planing) is the gold standard procedure in therapy for periodontitis. It involves the mechanical removal of plaque and bacterial deposits, creating a local microbial environment in harmony with periodontal health and promoting the replacement of damaged periodontal tissues with collagen-rich connective tissues. This favors a shift in the composition of the oral microbiota from a community dominated by Gram-negatives to one dominated by Gram-positives.

Also known as: scaling and root planing

Control Group without obesity; Obesity Group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Gender Eligibility Details: According to presence of periodontitis and obesity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• Men/Women with periodontitis:
• Periodontitis will be diagnosed according to the definition of the Centers for Disease Control and Prevention / American Academy of Periodontology (CDC/AAP).
• Men/Women with obesity:
• Body mass index (BMI) ≥30 kg/m2 (WHO 2000)

You may not qualify if:

• Having fewer than fourteen teeth,
• Having infectious diseases
• Having other oral inflammatory diseases,
• Having received periodontal treatment in the past six months or antibiotics in the previous three months, undergoing systemic anti-inflammatory treatment,
• Pregnancy or lactation
• Serious illnesses, congenital adrenal hyperplasia, virilizing tumors, hypothyroidism, Cushing's syndrome, prolactinomas, cardiovascular diseases, or diabetes mellitus.
• Alcohol or drug abuse
• Psychiatric disorders.

Sponsors & Collaborators

• Milagros Rocha Barajas: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (2)

University Hospital Dr Peset

Valencia, Valencia, 46017, Spain

Location

University Hospital Dr. Peset

Valencia, Valencia, 46017, Spain

Location

Related Publications (14)

• Fruhbeck G. Obesity: Screening for the evident in obesity. Nat Rev Endocrinol. 2012 Oct;8(10):570-2. doi: 10.1038/nrendo.2012.165. Epub 2012 Sep 4. No abstract available.

  PMID: 22945363 BACKGROUND

• Rocha VZ, Libby P. Obesity, inflammation, and atherosclerosis. Nat Rev Cardiol. 2009 Jun;6(6):399-409. doi: 10.1038/nrcardio.2009.55. Epub 2009 Apr 28.

  PMID: 19399028 BACKGROUND

• Tonetti MS. Periodontitis and risk for atherosclerosis: an update on intervention trials. J Clin Periodontol. 2009 Jul;36 Suppl 10:15-9. doi: 10.1111/j.1600-051X.2009.01417.x.

  PMID: 19432627 BACKGROUND

• Virto L, Cano P, Jimenez-Ortega V, Fernandez-Mateos P, Gonzalez J, Esquifino AI, Sanz M. Obesity and periodontitis: An experimental study to evaluate periodontal and systemic effects of comorbidity. J Periodontol. 2018 Feb;89(2):176-185. doi: 10.1902/jop.2017.170355. Epub 2018 Feb 16.

  PMID: 28914596 BACKGROUND

• Isaza-Guzman DM, Medina-Piedrahita VM, Gutierrez-Henao C, Tobon-Arroyave SI. Salivary Levels of NLRP3 Inflammasome-Related Proteins as Potential Biomarkers of Periodontal Clinical Status. J Periodontol. 2017 Dec;88(12):1329-1338. doi: 10.1902/jop.2017.170244. Epub 2017 Jul 10.

  PMID: 28691886 BACKGROUND

• Zhong Z, Liang S, Sanchez-Lopez E, He F, Shalapour S, Lin XJ, Wong J, Ding S, Seki E, Schnabl B, Hevener AL, Greenberg HB, Kisseleva T, Karin M. New mitochondrial DNA synthesis enables NLRP3 inflammasome activation. Nature. 2018 Aug;560(7717):198-203. doi: 10.1038/s41586-018-0372-z. Epub 2018 Jul 25.

  PMID: 30046112 BACKGROUND

• Moura MF, Navarro TP, Silva TA, Cota LOM, Soares Dutra Oliveira AM, Costa FO. Periodontitis and Endothelial Dysfunction: Periodontal Clinical Parameters and Levels of Salivary Markers Interleukin-1beta, Tumor Necrosis Factor-alpha, Matrix Metalloproteinase-2, Tissue Inhibitor of Metalloproteinases-2 Complex, and Nitric Oxide. J Periodontol. 2017 Aug;88(8):778-787. doi: 10.1902/jop.2017.170023. Epub 2017 May 11.

  PMID: 28492359 BACKGROUND

• Martinez-Herrera M, Lopez-Domenech S, Silvestre FJ, Silvestre-Rangil J, Banuls C, Victor VM, Rocha M. Chronic periodontitis impairs polymorphonuclear leucocyte-endothelium cell interactions and oxidative stress in humans. J Clin Periodontol. 2018 Dec;45(12):1429-1439. doi: 10.1111/jcpe.13027. Epub 2018 Nov 20.

  PMID: 30362144 BACKGROUND

• Chapple IL, Matthews JB. The role of reactive oxygen and antioxidant species in periodontal tissue destruction. Periodontol 2000. 2007;43:160-232. doi: 10.1111/j.1600-0757.2006.00178.x. No abstract available.

  PMID: 17214840 BACKGROUND

• Kanzaki H, Wada S, Narimiya T, Yamaguchi Y, Katsumata Y, Itohiya K, Fukaya S, Miyamoto Y, Nakamura Y. Pathways that Regulate ROS Scavenging Enzymes, and Their Role in Defense Against Tissue Destruction in Periodontitis. Front Physiol. 2017 May 30;8:351. doi: 10.3389/fphys.2017.00351. eCollection 2017.

  PMID: 28611683 BACKGROUND

• Park MH, Jeong SY, Na HS, Chung J. Porphyromonas gingivalis induces autophagy in THP-1-derived macrophages. Mol Oral Microbiol. 2017 Feb;32(1):48-59. doi: 10.1111/omi.12153. Epub 2016 Feb 24.

  PMID: 26792079 BACKGROUND

• Tonetti MS, D'Aiuto F, Nibali L, Donald A, Storry C, Parkar M, Suvan J, Hingorani AD, Vallance P, Deanfield J. Treatment of periodontitis and endothelial function. N Engl J Med. 2007 Mar 1;356(9):911-20. doi: 10.1056/NEJMoa063186.

  PMID: 17329698 BACKGROUND

• Luan X, Zhou X, Naqvi A, Francis M, Foyle D, Nares S, Diekwisch TGH. MicroRNAs and immunity in periodontal health and disease. Int J Oral Sci. 2018 Aug 6;10(3):24. doi: 10.1038/s41368-018-0025-y.

  PMID: 30078842 BACKGROUND

• Yoneda T, Tomofuji T, Ekuni D, Azuma T, Maruyama T, Fujimori K, Sugiura Y, Morita M. Serum microRNAs and chronic periodontitis: A case-control study. Arch Oral Biol. 2019 May;101:57-63. doi: 10.1016/j.archoralbio.2019.03.009. Epub 2019 Mar 13.

  PMID: 30889506 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Inflammation; Atherosclerosis; Gingivitis; Obesity

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Infections; Gingival Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Milagros Rocha, PhD

  FISABIO-HOSPITAL DR PESET

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Postdoctoral Researcher

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 15, 2024
• Study Start: April 15, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 31, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)