Clinical trial NCT04509505: Effect of Waterpipe Smoking on Periodontal Health
Official title: The Effect of Waterpipe Smoking on Periodontal Health Among a Sample of Adult Egyptian Patients. A Hospital Based Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Waterpipe Smoking
Periodontal Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.

Brief summary: The main objective of the study is to assess the effect of waterpipe smoking on periodontal health, which will be done using a well constructed validated questionnaire. Then a full periodontal examination and x-ray evaluation will be done for all of the participants.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients whose age is between 18-60 years old.
2. Patient consulting in the outpatient clinic.
3. Provide informed consent.

Exclusion Criteria:

1. Individuals with chronic systemic diseases such as diabetes, endocrine and hematological Pathologies.
2. Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
3. Pregnant women.
4. Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
5. Patients with orthodontic appliances.

Primary outcomes:
measure: periodontal health condition in waterpipe smokers.
timeFrame: through study completion, an average of 1 year.
Secondary outcomes:
measure: Impact of sociodemographic factors on periodontal health
timeFrame: through study completion, an average of 1 year.
measure: Impact of oral hygiene behaviour on periodontal health.
timeFrame: through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: Giza
Study officials:
affiliation: Professor of Oral medicine and Periodontology, Cairo University
name: Noha Ayman Ghallab, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.