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Effect of Waterpipe Smoking on Periodontal Health

Sponsor
Noha Ayman Ghallab (Other)
Overall Status
Completed
CT.gov ID
NCT04509505
Collaborator
(none)
323
Enrollment
1
Location
11.9
Actual Duration (Months)
27.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    323 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Effect of Waterpipe Smoking on Periodontal Health Among a Sample of Adult Egyptian Patients. A Hospital Based Cross-sectional Study
    Actual Study Start Date :
    Nov 1, 2020
    Actual Primary Completion Date :
    Sep 30, 2021
    Actual Study Completion Date :
    Oct 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. periodontal health condition in waterpipe smokers. [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.

    Secondary Outcome Measures

    1. Impact of sociodemographic factors on periodontal health [through study completion, an average of 1 year.]

      Questions regarding sociodemographic information such as educational level, income and marital status will be analyzed.

    2. Impact of oral hygiene behaviour on periodontal health. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry, Cairo University Cairo Giza Egypt 11865

    Sponsors and Collaborators

    • Noha Ayman Ghallab

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Noha Ayman Ghallab, Prof. Dr Noha Ayman Ghallab - Professor of Oral Medicine and Periodontology / Cairo University., Cairo University
    ClinicalTrials.gov Identifier:
    NCT04509505
    Other Study ID Numbers:
    • Mariam2020
    First Posted:
    Aug 12, 2020
    Last Update Posted:
    Mar 11, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Periodontal Diseases

    Study Results

    No Results Posted as of Mar 11, 2022