NCT04509843

Brief Summary

evaluation the relationship between the socioeconomic status and periodontal health of Egyptian adults.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
456

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 20, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

August 12, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

July 20, 2020

Last Update Submit

August 10, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Periodontal health

    Recently, definition of periodontal health has been developed dramatically from just the absence of a disease to a state around a stable periodontium (Lang and Bartold, 2018) that functions in comfort in an individual with psychological and social well-being about their mouth (Mariotti and Hefti, 2015). Based on this, biological, environmental, systemic, social, economic and psychological factors can affect periodontal health in different ways. Periodontal examination using the community periodontal index (CPI) will be done for all of the participants to assess the status of periodontal condition. The CPITN criteria used in this study will be as follows: score 0 = healthy periodontium with no sign of periodontal disease, score 1= gingival bleeding on probing, 2=calculus deposits, 3=pockets 4-5mm (shallow pockets), 4=pockets 6mm or deeper (deep pockets) and X =excluded sextants.

    "through study completion, an average of 1 year"

  • periodontal disease

    Periodontal diseases have been categorized in a new framework: stage I to VI of periodontitis based on severity, complexity of management with additional described extent as localized or generalized. Grade A to C of periodontitis related to the progression rate of the disease as slow, moderate and rapid with grade modifiers. The seriousness and the complexity of the disease are greater as the grade increases within each stage.(Tonetti, Greenwell and Kornman, 2018). Information on loss of attachment (CAL) will be collected from the same index teeth using CPI modified system. The two molars in each posterior sextant are paired for recording and if one is missing there is no replacement. If no index tooth is present in a sextant qualifying for examination, all teeth present in that sextant are examined and the highest score is recorded as the score for the sextant WHO.

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Impact of sociodemographic factors on periodontal health

    through study completion, an average of 1 year

  • impact of periodontal practice on periodontal health

    through study completion, an average of 1 year

Interventions

it is a cross-sectional study for assessment the impact of socioeconomic status on periodontal health through using a definite scale mentioned in the protocol related to the middle east people.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.

You may qualify if:

  • Patients whose age is 18-70 years old recruiting from the outpatient clinic and the payed 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.
  • pregnant patients.
  • patients undergoing orthodontic treatment.
  • patients who had undergone periodontal treatment over the past six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, 002, Egypt

RECRUITING

MeSH Terms

Interventions

Social Class

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

alsayed mo alsadany, master

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2020

First Posted

August 12, 2020

Study Start

September 1, 2020

Primary Completion

March 1, 2021

Study Completion

April 1, 2021

Last Updated

August 12, 2020

Record last verified: 2020-07

Locations