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

NCT03178838 | Completed DMC

• 1 other identifier: PSS2016/PARO-PROTO-BISSON/VS
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis, Adult

Outcome Measures

Primary Outcomes (1)

• Presence of protozoans

  baseline

Secondary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients consulting in the periodontal department of CHU, Nancy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Catherine BISSON, PhD

  CHRU Nancy / Université de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 7, 2017
• Study Start: December 3, 2013
• Primary Completion: November 11, 2014
• Study Completion: November 11, 2014
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share