Effect of Waterpipe Smoking on Periodontal Health

Periodontal Diseases Clinical Trial

Official title:

The Effect of Waterpipe Smoking on Periodontal Health Among a Sample of Adult Egyptian Patients. A Hospital Based Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04509505
• Other study ID #: Mariam2020
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: October 30, 2021

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: October 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases
• Waterpipe Smoking

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Noha Ayman Ghallab

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. — View Citation

Natto S, Baljoon M, Bergström J. Tobacco smoking and periodontal health in a Saudi Arabian population. J Periodontol. 2005 Nov;76(11):1919-26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	periodontal health condition in waterpipe smokers.	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	Impact of sociodemographic factors on periodontal health	Questions regarding sociodemographic information such as educational level, income and marital status will be analyzed.	through study completion, an average of 1 year.
Secondary	Impact of oral hygiene behaviour on periodontal health.	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.