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Completed

NCT Number: NCT03805724

Entamoeba Gingivalis and Periodontal Disease

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.

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Key information

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry, Cairo University

Cairo, 12411, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plaque Samples

Other

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.

Primary outcomes

  1. Presence of Entamoaba Gingivalis parasite in dental plaque assessed by direct microscopic examination

    Time frame: 2 weeks

    Direct microscopic detection of Entamoaba Gingivalis in dental plaque samples using Trichrome stain

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Is Entamoeba Gingivalis A Risk Factor In Periodontal Diseases

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2019
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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