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Entamoeba Gingivalis and Periodontal Disease

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ClinicalTrials.gov Identifier: NCT03805724
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Gihane Gharib Madkour, 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.

Condition or disease Intervention/treatment
Periodontal Diseases 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 2 Weeks
Official Title: Is Entamoeba Gingivalis A Risk Factor In Periodontal Diseases
Actual Study Start Date : July 13, 2018
Actual Primary Completion Date : January 18, 2019
Actual Study Completion Date : January 18, 2019

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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805724


Locations
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Egypt
Faculty of Dentistry, Cairo University
Cairo, Egypt, 12411
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Gihane G Madkour, Ass Prof Cairo University

Additional Information:

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Responsible Party: Gihane Gharib Madkour, Associate Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03805724     History of Changes
Other Study ID Numbers: 15062006
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases