Periodontopathogens of Periodontal Patients

Detection of Levels of Periodontopathogens in a Catalan Population of Periodontal Patients Visited in the HOUB

Study the presence of periodontal pathogens in a Catalan population with periodontitis and evaluate the influence of an intervention measure on oral hygiene teaching (video)

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases
• Intervention / Treatment: Behavioral: Video participants

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • University of Barcelona
      • Contact: José López López, Doctor; Phone Number: 34 606457362; Email: jl.lopez@ub.edu
      • Contact: Sonia Egido Moreno, DDS; Phone Number: 34 620172876; Email: soniaegido@ub.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients over 18 years of age
• periodontal disease (grade III and IV)
• gave their informed consent to participate in the study
• do not present associated medical pathology

Exclusion Criteria:

• Patients who do not wish to participate in the study
• Patients following active treatment with antibiotics or having received antibiotic treatment in the last seven days,
• Patients who wear braces.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video participants; Patients treated at the Hospital Odontològic Universitat de Barcelona (HOUB) who go for a routine visit in the period of the study and wish to participate. Parameters are measured and an oral hygiene teaching intervention is carried out.	Behavioral: Video participants; Showing a video of oral hygiene intructions; Other Names: Study group
No Intervention: Non video participants; Patients treated at the Hospital Odontològic Universitat de Barcelona (HOUB) who go for a routine visit in the period of the study and wish to participate. Parameters are measured and and no initial intervention is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of periodontopathogens	Study the presence of periodontogens in a Catalan population with periodontitis and evaluate the influence of an intervention measure in the form of oral hygiene education.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate the microbiota and pro-inflammatory cytokine data obtained in the study population with the literature.	Measure through conventional and molecular microbiological study of bacteria, looking for changes in the total count and measurement of cytokine through ELISA/cytometry test and search for quantitative changes	1 month
Determine if there are changes in the oral microbiota, before and after an intervention in the form of oral hygiene.	Measure through conventional and molecular microbiological study of bacteria, looking for changes in the total count	1 month
Determine if there are changes in the levels of pro-inflammatory cytokines, before and after an intervention measure in the form of oral hygiene.	Measurement through ELISA/cytometry test and search for quantitative changes	1 month
Correlate the level of periodontal disease with the patient's oral health.	Classification established in the World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions	1 month
Correlate the level of periodontal disease with the patient's systemic diseases	Classification established in the World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions and review of the clinical history	1 month
Correlate the variations in the oral microbiota with the patient's systemic diseases.	Measure through conventional and molecular microbiological study of bacteria, looking for changes in the total count and review of the clinical history	1 month
Correlate variations in the levels of pro-inflammatory cytokines with the patient's systemic diseases.	Measurement through ELISA/cytometry test and search for quantitative changes and review of the clinical history	1 month

Collaborators and Investigators

• Sponsor: University of Barcelona
• Collaborators: Teresa Vinuesa Aumedes; Albert Estrugo Devesa; Felipe Aguilera Muñoz; Ester Fuste Domínguez; Enric Jané Salas; Isabel Martínez Lizán; Sonia Egido Moreno; Carlos Omaña Cepeda; Alexandra Merlos Gil

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): November 15, 2023
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: oral hygiene; periodontopathogens; periodontal patients
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: Perio HOUB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No