NCT04509505

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

August 9, 2020

Last Update Submit

March 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Impact of sociodemographic factors on periodontal health

    through study completion, an average of 1 year.

  • Impact of oral hygiene behaviour on periodontal health.

    through study completion, an average of 1 year.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Giza Governorate, 11865, Egypt

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Water Pipe SmokingPeriodontal Diseases

Condition Hierarchy (Ancestors)

Pipe SmokingSmokingBehaviorMouth DiseasesStomatognathic Diseases

Study Officials

  • Noha Ayman Ghallab, MD

    Professor of Oral medicine and Periodontology, Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr Noha Ayman Ghallab - Professor of Oral Medicine and Periodontology / Cairo University.

Study Record Dates

First Submitted

August 9, 2020

First Posted

August 12, 2020

Study Start

November 1, 2020

Primary Completion

September 30, 2021

Study Completion

October 30, 2021

Last Updated

March 11, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations