Entamoeba Gingivalis and Periodontal Disease

NCT03805724 | Completed

• 1 other identifier: 15062006
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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

Chronic Gingivitis

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

Other: Plaque Samples

Interventions

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.

Chronic Gingivitis; Chronic Periodontitis; Periodontally healthy subjects

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Patients with any systemic diseases

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 12411, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Gihane G Madkour, Ass Prof

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 16, 2019
• Study Start: July 13, 2018
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: April 2, 2019

Record last verified: 2019-03

Locations

EG (1)