- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04509505
Effect of Waterpipe Smoking on Periodontal Health
The Effect of Waterpipe Smoking on Periodontal Health Among a Sample of Adult Egyptian Patients. A Hospital Based Cross-sectional Study
Study Overview
Status
Conditions
Detailed Description
The primary outcome of the study is to assess the effect of waterpipe smoking on periodontal health, it will be assessed by questions about smoking habits, including smoking mode as well as duration (heads smoked per day) and extent of use (age of initiation and number of sessions per week) of waterpipe smoking.
A full periodontal examination using UNC-15 periodontal probe will be done for all of the participants measuring the CAL, Probing Depth (PD), plaque index (PI), bleeding on probing (BOP) and gingival recession depth (GD). In subjects where attachment loss will be clinically detected, radiographic examination will be performed by digital periapical radiograph to detect the amount of bone loss, then staging will be done according to the new classification by the aid of radiographic examination.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Giza
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Cairo, Giza, Egypt, 11865
- Faculty of Dentistry, Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients whose age is between 18-60 years old.
- Patient consulting in the outpatient clinic.
- Provide informed consent.
Exclusion Criteria:
- Individuals with chronic systemic diseases such as diabetes, endocrine and hematological Pathologies.
- Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
- Pregnant women.
- Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
- Patients with orthodontic appliances.
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
periodontal health condition in waterpipe smokers.
Time Frame: through study completion, an average of 1 year.
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will be assessed from questions about smoking habits, including smoking mode as well as duration and extent of use of waterpipe smoking and measuring the CAL for staging the periodontal condition according to the new classification by the aid of radiographic examination.
|
through study completion, an average of 1 year.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of sociodemographic factors on periodontal health
Time Frame: through study completion, an average of 1 year.
|
Questions regarding sociodemographic information such as educational level, income and marital status will be analyzed.
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through study completion, an average of 1 year.
|
Impact of oral hygiene behaviour on periodontal health.
Time Frame: through study completion, an average of 1 year.
|
Questions regarding oral health behaviors such as toothbrushing frequency, use of auxiliary aids, dental visits and toothbrushing method will be analyzed too.
|
through study completion, an average of 1 year.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Noha Ayman Ghallab, MD, Professor of Oral Medicine and Periodontology, Cairo University
Publications and helpful links
General Publications
- Natto S, Baljoon M, Bergstrom J. Tobacco smoking and periodontal health in a Saudi Arabian population. J Periodontol. 2005 Nov;76(11):1919-26. doi: 10.1902/jop.2005.76.11.1919.
- Alzyoud S, Veeranki SP, Kheirallah KA, Shotar AM, Pbert L. Validation of the Waterpipe Tolerance Questionnaire Among Jordanian School-Going Adolescent Waterpipe Users. Glob J Health Sci. 2015 Jun 25;8(2):198-208. doi: 10.5539/gjhs.v8n2p198.
- Al-Alimi A, Halboub E, Al-Sharabi AK, Taiyeb-Ali T, Jaafar N, Al-Hebshi NN. Independent determinants of periodontitis in Yemeni adults: A case-control study. Int J Dent Hyg. 2018 Nov;16(4):503-511. doi: 10.1111/idh.12352. Epub 2018 Jul 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mariam2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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