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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04478864
Other study ID # Esraa2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 27, 2020
Est. completion date November 30, 2021

Study information

Verified date March 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main objective of the study is to assess the knowledge and practice of periodontal health, which will be done using a well constructed and validated questionnaire. Then periodontal health status of all participants will be assessed via clinical examination of certain teeth.


Description:

The primary outcome of the study is the knowledge of periodontal health.It will be assessed by 10 questions focusing on the basic knowledge of gingival appearance, causes and consequence of periodontal disease, impact of systemic disease on the progression of periodontal conditions, and prevention. Then, 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. Periodontal examination using the community periodontal index (CPI) will be done for all of the participants to assess the status of periodontal condition. The dentition will be divided into sextants and the highest code number corresponding to the worst periodontal condition around each of the 10 indexed teeth being recorded.


Recruitment information / eligibility

Status Completed
Enrollment 511
Est. completion date November 30, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: 1. Patients whose age is above 15 years old. 2. Patient consulting in the outpatient clinic 3. Provide informed consent. Exclusion Criteria: 1. Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible. 2. Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Faculty of Oral & Dental Medicine - Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Noha Ayman Ghallab

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Grönbeck Lindén I, Hägglin C, Gahnberg L, Andersson P. Factors Affecting Older Persons' Ability to Manage Oral Hygiene: A Qualitative Study. JDR Clin Trans Res. 2017 Jul;2(3):223-232. doi: 10.1177/2380084417709267. Epub 2017 May 15. — View Citation

Holtzman JS, Atchison KA, Macek MD, Markovic D. Oral Health Literacy and Measures of Periodontal Disease. J Periodontol. 2017 Jan;88(1):78-88. Epub 2016 Aug 13. — View Citation

Murakami S, Mealey BL, Mariotti A, Chapple ILC. Dental plaque-induced gingival conditions. J Periodontol. 2018 Jun;89 Suppl 1:S17-S27. doi: 10.1002/JPER.17-0095. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Knowledge of periodontal health will be assessed from the 10 questions in the questionnaire and be presented as frequencies and percentages. "through study completion, an average of 1 year"
Secondary Periodontal health practice Five questions regarding practice will be analyzed and presented as frequencies and percentages "through study completion, an average of 1 year"
Secondary State of periodontal health will be determined by measuring the community periodontal index of treatment needs (CPITN) and modified community periodontal index (CPI) that measures the clinical attachment level (CAL) scores, both giving a score of zero to the best periodontal condition and a score of 4 to the worst one "through study completion, an average of 1 year"
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