Effect of Waterpipe Smoking on Periodontal Health

March 10, 2022 updated by: Noha Ayman Ghallab

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

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

323

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Giza
      • Cairo, Giza, Egypt, 11865
        • Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Noha Ayman Ghallab, MD, Professor of Oral Medicine and Periodontology, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

August 9, 2020

First Submitted That Met QC Criteria

August 9, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Mariam2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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