Entamoeba Gingivalis and Periodontal Disease

NCT ID: NCT03805724

Last Updated: 2019-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-13

Study Completion Date

2019-01-18

Brief Summary

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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

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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.

Conditions

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Periodontal Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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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.

Plaque Samples

Intervention Type 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.

Chronic Periodontitis

Chronic periodontitis patients having probing depth of ≥3 mm and clinical attachment level ≥ 1 mm. Plaque samples will be collected.

Plaque Samples

Intervention Type 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.

Chronic Gingivitis

Gingivitis patients having signs of clinical inflammation with no clinical attachment loss. Plaque samples will be collected

Plaque Samples

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Gihane Gharib Madkour

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gihane G Madkour, Ass Prof

Role: STUDY_DIRECTOR

Cairo University

Locations

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Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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15062006

Identifier Type: -

Identifier Source: org_study_id

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