- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06424600
Ginglival Health Among Smokers Visiting Dental Hospital
June 22, 2024 updated by: Afsheen Mansoor, Pakistan Institute of Medical Sciences
Effect of Various Forms of Nicotine Consumption on Gingival Health of Dental Patients.
The effect of different forms of nicotine intake on the gingival health of dental patients that visited a public sector in Islamabad.
A total of 300 dental patients that visited School of Dentistry, Islamabad voluntarily participated in this study.
The nicotine consuming participants involved in this study were Smoke-form users, E cigarette-form users, and Dual-form users whose Gingival Index (G-I) was inspected to demonstrate an association between their smoking type and duration of developing severe gingivitis.
Study Overview
Detailed Description
A total of 300 dental patients who visited the School of Dentistry, Islamabad, participated voluntarily in this study.
The nicotine-consuming participants involved in this study were Smoke-Form users (S-form), Electronic cigarette-form users (E-form), and Dual-Form users (D-form) whose Gingival Index (G-I) was inspected to demonstrate an association between their smoking type and duration of developing severe gingivitis.
The G-I ranging between 0.5 - 2.00 was used to calculate the occurrence of severe gingival issues in participants with smoking habits where G-I between 0.50 1.00 displayed Light gingival inflammation, G-I between 1.10-2.00
revealed Moderate gingival inflammation and G-I > 2.00 confirmed Severe gingival inflammation.
A chi-Square test was used for the association by keeping significance p< 0.05.
Study Type
Observational
Enrollment (Actual)
300
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
-
-
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Islamabad, Pakistan, 44080
- Afsheen Mansoor
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients visiting Dental Outpatient Department with history of Smoking
Description
Inclusion Criteria:
- Smokers with good general health status visiting dental hospital
Exclusion Criteria:
- Non-smoker dental patients
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
S-form users
Smoke- form users
|
The G-I index ranging between 0.5-2 was used to calculate the occurrence of severe gingival issues in participants with smoking habits.
The G-I index between 0.50-1.00
displayed light gingival inflammation, G-I between 1.10-2.00
revealed moderate gingival inflammation and G-I > 2.00 confirmed severe gingival inflammation.
|
|
E-form users
E-Cigarette users
|
The G-I index ranging between 0.5-2 was used to calculate the occurrence of severe gingival issues in participants with smoking habits.
The G-I index between 0.50-1.00
displayed light gingival inflammation, G-I between 1.10-2.00
revealed moderate gingival inflammation and G-I > 2.00 confirmed severe gingival inflammation.
|
|
D-form users
Dual-Form users
|
The G-I index ranging between 0.5-2 was used to calculate the occurrence of severe gingival issues in participants with smoking habits.
The G-I index between 0.50-1.00
displayed light gingival inflammation, G-I between 1.10-2.00
revealed moderate gingival inflammation and G-I > 2.00 confirmed severe gingival inflammation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gingival Index
Time Frame: one year
|
The G-I ranging between 0.5-2 was used to calculate the occurrence of severe gingival issues in participants with smoking habits where G-I between 0.50-1.00
displayed Light gingival inflammation, G-I between 1.10-2.00
revealed Moderate gingival inflammation and G-I > 2.00 confirmed Severe gingival inflammation.
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Afsheen Mansoor, Pakistan Institute of Medical Sciences
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)
February 3, 2023
Primary Completion (Actual)
February 4, 2024
Study Completion (Actual)
February 4, 2024
Study Registration Dates
First Submitted
May 16, 2024
First Submitted That Met QC Criteria
May 16, 2024
First Posted (Actual)
May 22, 2024
Study Record Updates
Last Update Posted (Actual)
June 25, 2024
Last Update Submitted That Met QC Criteria
June 22, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
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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