Entamoeba Gingivalis and Periodontal Disease

Completed

• Conditions: Periodontal Diseases
• Interventions: Other: Plaque Samples

• Registration Number: NCT03805724
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-07-13
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Primary Completion: 2019-01-18
• Study Completion: 2019-01-18
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Periodontitis	Plaque Samples	Chronic periodontitis patients having probing depth of ≥3 mm and clinical attachment level ≥ 1 mm. Plaque samples will be collected.
Chronic Gingivitis	Plaque Samples	Gingivitis patients having signs of clinical inflammation with no clinical attachment loss. Plaque samples will be collected
Periodontally healthy subjects	Plaque Samples	They will be selected from healthy subjects who attend the restorative dental clinic and has clinically healthy gingiva with zero plaque index, gingival index and clinical attachment level \& probing depth ≤ 3 mm. Plaque samples will be collected.

Primary Outcome Measures

Name	Time	Method
Presence of Entamoaba Gingivalis parasite in dental plaque assessed by direct microscopic examination	2 weeks	Direct microscopic detection of Entamoaba Gingivalis in dental plaque samples using Trichrome stain

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt