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

Preliminary Clinical Study of the Presence of Trichomonas Tenax and Entamoeba Gingivalis in Patients With Periodontitis Consulting to CHU of Nancy, in Periodontal Department.

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis, Adult

• Study Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients consulting in the periodontal department of CHU, Nancy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of protozoans	baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Periodontal pocket depth (mm)	baseline
Clinical attachment loss (mm)	baseline
Plaque and gingival index	baseline
Mobility of the tooth (Yes/No)	baseline
Presence of bleeding on probing (Yes/No)	baseline

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Catherine BISSON, PhD, CHRU Nancy / Université de Lorraine

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2013
• Primary Completion (Actual): November 11, 2014
• Study Completion (Actual): November 11, 2014

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: PSS2016/PARO-PROTO-BISSON/VS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Commission Nationale de l'Informatique et des libertés

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No