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NCT06424600 Clinical Trial

Ginglival Health Among Smokers Visiting Dental Hospital

Smoking Clinical Trial

Official title:
Effect of Various Forms of Nicotine Consumption on Gingival Health of Dental Patients.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06424600
Other study ID # SOD/ERB/2023/32-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 3, 2023
Est. completion date February 4, 2024

Study information
Verified date May 2024
Source Pakistan Institute of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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. 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.

Description:

A total of 300 dental patients that visited School of Dentistry, Islamabad, participated voluntarily 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. 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. A chi-Square test was used for the association by keeping significance < 0.05.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date February 4, 2024
Est. primary completion date February 4, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Smokers with good general health status visiting dental hospital Exclusion Criteria: - Non-smoker dental patients

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Gingival Index
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.

Locations
Country Name City State
Pakistan Afsheen Mansoor Islamabad

Sponsors (1)
Lead Sponsor Collaborator
Pakistan Institute of Medical Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Tomar SL, Hecht SS, Jaspers I, Gregory RL, Stepanov I. Oral Health Effects of Combusted and Smokeless Tobacco Products. Adv Dent Res. 2019 Oct;30(1):4-10. doi: 10.1177/0022034519872480. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Gingival Index 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
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