Waterpipe SmokingNCT04509505
Effect of Waterpipe Smoking on Periodontal Health
An observational study of Waterpipe Smoking and Periodontal Diseases, run by Noha Ayman Ghallab at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Waterpipe Smoking, Periodontal Diseases
- How many people
- 323 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 30 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.
Who may be able to join
- Patients whose age is between 18-60 years old.
- Patient consulting in the outpatient clinic.
- Provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo, Giza Governorate, 11865
About this study
Official title: 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.
Read the 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.
- Conditions
- Waterpipe Smoking, Periodontal Diseases
- Medical subject headings
- Water Pipe Smoking, Periodontal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year.
Secondary outcomes (2)
Impact of sociodemographic factors on periodontal health
Questions regarding sociodemographic information such as educational level, income and marital status will be analyzed.
Measured: through study completion, an average of 1 year.
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.
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Nov 2020
- Primary completion30 Sep 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Waterpipe SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noha Ayman Ghallab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Ayman Ghallab, Cairo University
- Investigators
- Noha Ayman Ghallab, MD, Study director, Professor of Oral medicine and Periodontology, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509505
- Sponsor's protocol ID
- Mariam2020
- Status last verified
- Mar 2022
- First submitted
- 9 Aug 2020
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16274311Alzyoud 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.
PubMed 26383198Al-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.
PubMed 29963753
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Waterpipe Smoking on Periodontal Health Among a Sample of Adult Egyptian Patients. A Hospital Based Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04509505
- Acronym / sponsor ID
- Mariam2020
- Conditions
- Waterpipe Smoking, Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Noha Ayman GhallabUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.
Key inclusion criteria (3 listed)
- Patients whose age is between 18-60 years old.
- Patient consulting in the outpatient clinic.
- Provide informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Impact of sociodemographic factors on periodontal health
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Results publication: PubMed 16274311Natto 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.
- Results publication: PubMed 26383198Alzyoud 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.
- Results publication: PubMed 29963753Al-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noha Ayman Ghallab, MD study director
Professor of Oral medicine and Periodontology, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Waterpipe Smoking and Periodontal Diseases, run by Noha Ayman Ghallab at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
periodontal health condition in waterpipe smokers. (time frame: through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509505, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.