Back to resultsPeriodontopathogens of Periodontal Patients
Primary Purpose
Periodontal Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Video participants
Sponsored by
About this trial
This is an interventional diagnostic trial for Periodontal Diseases focused on measuring periodontopathogens, oral hygiene, periodontal patients
Eligibility Criteria
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.
Sites / Locations
- University of BarcelonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Video participants
Non video participants
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
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
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
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
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
Full Information
NCT ID
NCT05940714
First Posted
June 14, 2023
Last Updated
July 3, 2023
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
1. Study Identification
Unique Protocol Identification Number
NCT05940714
Brief Title
Periodontopathogens of Periodontal Patients
Official Title
Detection of Levels of Periodontopathogens in a Catalan Population of Periodontal Patients Visited in the HOUB
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
October 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
periodontopathogens, oral hygiene, periodontal patients
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Video participants
Arm Type
Experimental
Arm Description
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.
Arm Title
Non video participants
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Video participants
Other Intervention Name(s)
Study group
Intervention Description
Showing a video of oral hygiene intructions
Primary Outcome Measure Information:
Title
Presence of periodontopathogens
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Correlate the microbiota and pro-inflammatory cytokine data obtained in the study population with the literature.
Description
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
Time Frame
1 month
Title
Determine if there are changes in the oral microbiota, before and after an intervention in the form of oral hygiene.
Description
Measure through conventional and molecular microbiological study of bacteria, looking for changes in the total count
Time Frame
1 month
Title
Determine if there are changes in the levels of pro-inflammatory cytokines, before and after an intervention measure in the form of oral hygiene.
Description
Measurement through ELISA/cytometry test and search for quantitative changes
Time Frame
1 month
Title
Correlate the level of periodontal disease with the patient's oral health.
Description
Classification established in the World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions
Time Frame
1 month
Title
Correlate the level of periodontal disease with the patient's systemic diseases
Description
Classification established in the World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions and review of the clinical history
Time Frame
1 month
Title
Correlate the variations in the oral microbiota with the patient's systemic diseases.
Description
Measure through conventional and molecular microbiological study of bacteria, looking for changes in the total count and review of the clinical history
Time Frame
1 month
Title
Correlate variations in the levels of pro-inflammatory cytokines with the patient's systemic diseases.
Description
Measurement through ELISA/cytometry test and search for quantitative changes and review of the clinical history
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Barcelona
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José López López, Doctor
Phone
606457362
Ext
34
Email
jl.lopez@ub.edu
First Name & Middle Initial & Last Name & Degree
Sonia Egido Moreno, DDS
Phone
620172876
Ext
34
Email
soniaegido@ub.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Periodontopathogens of Periodontal Patients
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