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Paro-Proto 2: Clinical Study of the Presence of Trichomonas Tenax and Entamoeba Gingivalis in Patients With Periodontitis

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT03178838
Collaborator
(none)
50
Enrollment
11.3
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The buccal cavity presents microorganismes whose the number and composition vary with oral hygiene and medical context (pathologies and associated drug therapies) of the patient. More than 1200 bacterial species have been identified, and among them, 400 are inhabitants of the sub-gingival biofilm. Among all these microorganismes, only 20 species participate to the etiopathogenesis of periodontal diseases.Some are recognised as major periodontopathogens other play unclear role in this pathology. They belong respectively to the red and orange complex of Socransky et al. (1998).

Other microorganismes such as virures, yeasts and protozoans could potentially impact the emergence and development of periodontal diseases. The presence of protozoans in periodontitis have been investigated in this study.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Preliminary Clinical Study of the Presence of Trichomonas Tenax and Entamoeba Gingivalis in Patients With Periodontitis Consulting to CHU of Nancy, in Periodontal Department.
    Actual Study Start Date :
    Dec 3, 2013
    Actual Primary Completion Date :
    Nov 11, 2014
    Actual Study Completion Date :
    Nov 11, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Presence of protozoans [baseline]

    Secondary Outcome Measures

    1. Periodontal pocket depth (mm) [baseline]

    2. Clinical attachment loss (mm) [baseline]

    3. Plaque and gingival index [baseline]

    4. Mobility of the tooth (Yes/No) [baseline]

    5. Presence of bleeding on probing (Yes/No) [baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adults > 18 years-old

    • Consulting in periodontal department of CHU, Nancy

    • Patient with moderate to severe periodontitis

    • At least 2 periodontal sites with PPD≥ 4mm and One healthy site

    • No scaling root planning in the last 6 months

    • Patients insured under the French social security system

    Exclusion Criteria:

    • Pregnant patients

    • Patients with antibiotic therapy, and/or all medecines which could modify the buccal microbiota in the last 6 months

    • Tooth with endodontic periapical lesion

    • Patients having a scaling root planning in the last 6 months

    • Patient with guardianship

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    • Principal Investigator: Catherine BISSON, PhD, CHRU Nancy / Université de Lorraine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT03178838
    Other Study ID Numbers:
    • PSS2016/PARO-PROTO-BISSON/VS
    First Posted:
    Jun 7, 2017
    Last Update Posted:
    Nov 14, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Periodontitis
    Chronic Periodontitis

    Study Results

    No Results Posted as of Nov 14, 2017