NCT05065034

Brief Summary

Antibiotics are currently used in periodontology to specifically target the most pathogenic bacteria in subgingival biofilms and to improve treatments. The multiplicity of protocols / dosages tested and the variability of the results did not make it possible to reach an international consensus on antibiotic therapy and its cost / benefit ratio, in particular with regard to the significant side effects of taking antibiotics (resistance bacterial). The care environment as well as the clinical, biological and microbiological parameters can strongly influence the results in usual treatment.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 29, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2023

Completed
Last Updated

October 12, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

September 29, 2021

Last Update Submit

October 4, 2021

Conditions

Keywords

PeriodontitisInflammatory diseasesPeriodontalTeethAesthetic morbidityCardiovascular riskSupragingivalSubgingivalBiofilmsProsthetic restorations

Outcome Measures

Primary Outcomes (1)

  • A retrospective study of the use of antibiotic therapy on the short and long-term results of periodontitis treatments

    Files analysed retrospectively from January 01, 2012 to July 07, 2021 will be examined]

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient adult treated for periodontitis

You may qualify if:

  • Patient over 18 years old
  • Patient treated for periodontitis between 01/01/2012 and 07/31/2021
  • Patient whose medical and periodontal file contains all the elements necessary for data analysis
  • Subject not having expressed, after information, his opposition to the reuse of his medical data for the purposes of this research.

You may not qualify if:

  • Patient who expressed his opposition to participating in the study
  • Patient without periodontitis
  • Patient smoking more than 10 cigarettes / day
  • Patient presenting a dilapidated oral state (untreated caries, unrestored teeth), oral infectious foci whose management requires antibiotic treatment during the initial treatment
  • Impossibility of giving the subject informed information
  • Subject under safeguard of justice
  • Subject under guardianship or guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Médecine et de Chirurgie Bucco-Dentaires - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Chronic PeriodontitisPeriodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Luc DAVIDEAU, MD, PhD

    Service de Médecine et de Chirurgie Bucco-Dentaires - Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saïd CHAYER, PhD, HDR

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 1, 2021

Study Start

September 29, 2021

Primary Completion

June 25, 2023

Study Completion

June 25, 2023

Last Updated

October 12, 2021

Record last verified: 2021-09

Locations