Entamoeba Gingivalis and Periodontal Disease

Is Entamoeba Gingivalis A Risk Factor In Periodontal Diseases

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Other: Plaque Samples

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12411
    • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Gingivitis & Chronic periodontitis patients will be selected from the outpatients Clinic, Department of Oral Medicine, Periodontology and Diagnosis, Faculty of Dentistry, Fayoum University. Clinical examination for all patients will be performed including the following periodontal parameters: plaque index, gingival index, probing depth, and clinical attachment level. These measurements will be recorded by a single calibrated expert examiner at six sites for all teeth (mesiobuccal, mesiolingual, midbuccal, distobuccal, distolingual, and midlingual). PI is assessed by measuring the presence or absence of supragingival biofilm with a sweeping movement of the probe around the surfaces of all teeth

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Periodontally healthy subjects; 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.	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.
Chronic Periodontitis; Chronic periodontitis patients having probing depth of ≥3 mm and clinical attachment level ≥ 1 mm. Plaque samples will be collected.	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.
Chronic Gingivitis; Gingivitis patients having signs of clinical inflammation with no clinical attachment loss. Plaque samples will be collected	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Gihane G Madkour, Ass Prof, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2018
• Primary Completion (Actual): January 18, 2019
• Study Completion (Actual): January 18, 2019

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: 15062006

Drug and device information, study documents

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