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Completed

NCT Number: NCT03178838

Clinical Study of the Presence of Trichomonas Tenax and Entamoeba Gingivalis in Patients With Periodontitis

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.

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Key information

Conditions

Periodontitis, Adult Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Presence of protozoans

    Time frame: baseline

Secondary outcomes

  1. Periodontal pocket depth (mm)

    Time frame: baseline

  2. Clinical attachment loss (mm)

    Time frame: baseline

  3. Plaque and gingival index

    Time frame: baseline

  4. Mobility of the tooth (Yes/No)

    Time frame: baseline

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

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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.

Acronym: Paro-Proto 2

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 7, 2017
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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