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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04509843
Other study ID # 3-4-20
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date April 1, 2021

Study information

Verified date July 2020
Source Cairo University
Contact alsayed mo alsadany, master
Phone +201094741442
Email alsayed.alsadany@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Description:

It is a cross-sectional study for evaluation and assessment of periodontal health, socioeconomic status and oral hygiene measurements among Egyptian adults recruiting from the outpatient clinic and the payed treatment clinics at faculty of Dentistry, Cairo University.

The faculty of Dentistry, Cairo University is an open public facility, a tertiary healthcare and a referral center.


Recruitment information / eligibility

Status Recruiting
Enrollment 456
Est. completion date April 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- -Patients whose age is 18-70 years old recruiting from the outpatient clinic and the payed clinic

- Provide informed consent.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
socioeconomic status
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.

Locations

Country Name City State
Egypt Faculty of Dentistry Cairo

Sponsors (1)

Lead Sponsor Collaborator
Alsayed Mohamed Alsayed Alsadany

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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"
Primary 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 Impact of sociodemographic factors on periodontal health Patient-centered approaches turned to be more popular, which increased the attention to the effects of different human health situations on periodontal health through the concept that the way in which an individual` lives may produce behavioural patterns that are either beneficial or determinable to health including socioeconomic status.
Social class will be classified according to following socioeconomic status scale for health research in Egypt into low, moderate and high socioeconomic subgroups described by El-Gilany et al. (El-Gilany, El-Wehady and El-Wasify, 2012) This scale includes 7 domains with a total score of 84. Socioeconomic level: to be classified into very low, low, middle and high levels depending on the quartiles of the score calculated.
through study completion, an average of 1 year
Secondary impact of periodontal practice on periodontal health (Lertpimonchai et al., 2017) concluded that fair to poor oral hygiene measures especially irregular tooth brushing increases the risk of periodontal disease by two to five folds in conjunction with low frequency tooth brushing which was conducted in a systematic-review with severe forms of periodontal diseases.
periodontal practice will be addressed via several questions that evaluate the self-care practices of tooth brushing, flossing, mouth rinsing in recent one year, scaling in recent five years, and how to alleviate gingival bleeding if there is.The questionnaire will be filled through a face-to-face personal interview with the patient using simple, short, easily comprehended questions.
through study completion, an average of 1 year
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