NCT05278468

Brief Summary

The study is a case control study investigating the association between Periodontitis and Coronavirus disease (COVID-19) in Egyptian dental patients attending the oral diagnosis clinic at faculty of Dentistry, Cairo University.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

March 11, 2022

Last Update Submit

February 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The association between Poor oral hygiene and Coronavirus disease (COVID-19).

    after periodontal examination to the 2 groups who are subjected to PCR tests, will we find association between them

    1 year

Study Arms (2)

case group

Adult Egyptian participants attending the diagnostic center at faculty of Dentistry, Cairo University who had positive real-time reverse transcription polymerase chain reaction results for severe acute respiratory syndrome coronavirus-19 (COVID-19) infection.

Other: PCR test for covid-19

control group

Adult Egyptian participants attending the diagnostic center at faculty of Dentistry, Cairo University with negative positive real-time reverse transcription polymerase chain reaction results for severe acute respiratory syndrome coronavirus-19 (COVID-19) infection.

Other: PCR test for covid-19

Interventions

real-time reverse transcription polymerase chain reaction results for severe acute respiratory syndrome coronavirus-19 (COVID-19) infection.

case groupcontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients visiting the dedicated COVID Outpatient Clinic who will undergo real-time reverse transcription polymerase chain reaction (rRT-PCR) for the diagnosis of COVID-19 will be recruited for the study. Subsequently, prior to data analysis, the patients for whom complete set of data will be available will be categorized as either case or control depending on the results of rRT-PCR test by the supervisor. Patients who will have positive rRT-PCR results will be included in the case group, and patients with negative results will be included in the control group. Patients in the control group will be scheduled for an oral examination after the negative rRT-PCR, and patients who were positive for the virus (case group) will be scheduled for an oral examination after the completion of treatment when they will be determined to be disease free through a negative rRT-PCR. peridontal examination will be performed.

You may qualify if:

  • Patients aged 18 years old and above.
  • Patient consulting in the outpatient clinic
  • Provide informed consent.

You may not qualify if:

  • Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
  • Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
  • Completely edentulous patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omar Khaled Gamil

Giza, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 14, 2022

Study Start

August 15, 2022

Primary Completion

October 15, 2022

Study Completion

October 15, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations