Entamoeba Gingivalis and Periodontal Disease

Periodontal Diseases Clinical Trial

Official title:

Is Entamoeba Gingivalis A Risk Factor In Periodontal Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805724
• Other study ID #: 15062006
• Status: Completed
• Start date: July 13, 2018
• Est. completion date: January 18, 2019

Study information

• Verified date: March 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This current study aims to clarify the relationship between the occurrence of Entamoeba gingivalis infection and the specter of gingivitis & chronic periodontitis among Egyptian patients in comparison to healthy volunteers as a control group.

Description:

Three groups will be included in the current study. 40 Plaque samples will be collected from gingivitis patients (group 1), 40 from chronic periodontitis patients (group 2) plus 40 samples from healthy volunteers (group 3). Diagnosis of parasitic stages will rely on direct microscopic detection using permanent stains, Trichrome stain and haematoxylin and eosin stain in addition to direct wet mount examination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 18, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

• Chronic Gingivitis patients with signs of clinical inflammation with no clinical attachment loss.

• Chronic Periodontitis patients having probing depth of =3 mm and clinical attachment level = 1 mm.

• The control group: healthy subjects who attend the restorative dental clinic and had clinically healthy gingiva.

Exclusion Criteria:

• Patients with any systemic diseases

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Other:
• Plaque Samples
After carefully drying of the selected site and isolation by cotton roll, plaque samples will be collected by sweeping movement of the probe at gingival crevices of the tooth aspect with pervious inclusion criteria for obtaining of the plaque sample. Samples will be immediately dipped in sterile Eppendorf tubes containing PVA.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Entamoaba Gingivalis parasite in dental plaque assessed by direct microscopic examination	Direct microscopic detection of Entamoaba Gingivalis in dental plaque samples using Trichrome stain	2 weeks