NCT05940714

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)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

May 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

June 14, 2023

Last Update Submit

July 3, 2023

Conditions

Keywords

periodontopathogensoral hygieneperiodontal patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Correlate the microbiota and pro-inflammatory cytokine data obtained in the study population with the literature.

    1 month

  • Determine if there are changes in the oral microbiota, before and after an intervention in the form of oral hygiene.

    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.

    1 month

  • Correlate the level of periodontal disease with the patient's oral health.

    1 month

  • Correlate the level of periodontal disease with the patient's systemic diseases

    1 month

  • +2 more secondary outcomes

Study Arms (2)

Video participants

EXPERIMENTAL

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

Non video participants

NO INTERVENTION

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.

Interventions

Showing a video of oral hygiene intructions

Also known as: Study group
Video participants

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 11, 2023

Study Start

May 15, 2023

Primary Completion

November 15, 2023

Study Completion

October 15, 2024

Last Updated

July 11, 2023

Record last verified: 2023-07

Locations