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Protozoans in Biofilm From Patients With Periodontitis

Multicentric Clinical Trials on the Prevalence of Entamoeba Gingivalis and Its Associated Bacterial Flora in Patients With Periodontitis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03240666
Acronym
Paro-Proto
Enrollment
231
Registered
2017-08-07
Start date
2017-04-10
Completion date
2022-11-30
Last updated
2021-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis, Adult

Brief summary

The buccal cavity is colonized by numerous microorganisms whose the number and composition could be modified with medical background (diseases and drugs) and the level of oral hygiene of the patients. Among all microorganisms identified in the periodontium, few of them are implicated in the etiopathogenesis of periodontal pathologies. To date, four major bacteria are identified for their ability to degrade periodontal tissues. Although the periodontitis is established to be the consequence of bacterial virulence and immune dysfunction, these factors fail to explain the refractory periodontitis of some patients to etiologic treatment . Others microorganisms such as protozoans could have an impact on this disease.

Interventions

non applicable

Sponsors

Centre Hospitalier Universitaire de Nice
CollaboratorOTHER
University Hospital, Toulouse
CollaboratorOTHER
Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adults \> 18 years-old * consulting in periodontal department of CHRU * Patients with moderate to severe periodontitis * At least 2 periodontal sites with PPD ≥ 5mm and one healthy site * No scaling root planing in the last 6 months * Patients insured under the Franch social security system

Exclusion criteria

* Pregnants patients * Patients with antibiotic therapy and/ or all medecines which could modify the buccal microbiota in the last 6 months * Tooth with endodontics periapical lesion * Patients having a scaling root planing in the last 6 months * Patients with guardianship

Design outcomes

Primary

MeasureTime frameDescription
presence of protozoans6 months after the last inclusion: DNA samples were frozen and identified later.identification of protozoans by molecular technique (PCR) -

Secondary

MeasureTime frameDescription
Periodontal pocket depth (PPD in mm)One day: measure realised during examination of the patient for periodontal treatment.Measure of PPD thanks to periodontal probe
Clinical attachment Loss (CAL in mm)One day: measure realied during clincal examination of patient.Measure of CAL with periodontal probe
Plaque and gingival indexOne day: measure of index during the clinical examination of patient.Measure of plaque and gingival index (Loe and Silness, Silness and Loe)
Mobility of toothOne day: measure of tooth mobility during the clinical examination of patient.Measure of tooth mobility: Yes or not
Bleeding On Probing (BOP)One day: measure of BOP during the clinical examination of patient.Measure of BOP : Yes or not

Countries

France

Contacts

Primary ContactEl Mehdi SIAGHY
m.siaghy@chru-nancy.fr+33 383 15 52 85

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026