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

Periodontitis, Adult Clinical Trial

— Paro-Proto 2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178838
• Other study ID #: PSS2016/PARO-PROTO-BISSON/VS
• Status: Completed
• Phase: N/A
• First received: June 6, 2017
• Last updated: November 13, 2017
• Start date: December 3, 2013
• Est. completion date: November 11, 2014

Study information

• Verified date: November 2017
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 11, 2014
• Est. primary completion date: November 11, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Periodontitis, Adult
• Trichomonas Infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of protozoans		baseline
Secondary	Periodontal pocket depth (mm)		baseline
Secondary	Clinical attachment loss (mm)		baseline
Secondary	Plaque and gingival index		baseline
Secondary	Mobility of the tooth (Yes/No)		baseline
Secondary	Presence of bleeding on probing (Yes/No)		baseline