NCT06424600

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

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

Study Start

First participant enrolled

February 3, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

May 16, 2024

Last Update Submit

June 22, 2024

Conditions

Keywords

GingivalSmokers

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

S-form users

Smoke- form users

Other: Gingival Index

E-form users

E-Cigarette users

Other: Gingival Index

D-form users

Dual-Form users

Other: Gingival Index

Interventions

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 usersE-form usersS-form users

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients visiting Dental Outpatient Department with history of Smoking

You may qualify if:

  • Smokers with good general health status visiting dental hospital

You may not qualify if:

  • Non-smoker dental patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afsheen Mansoor

Islamabad, 44080, Pakistan

Location

Related 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.

    PMID: 31538806BACKGROUND

MeSH Terms

Conditions

Smoking

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Dental Health SurveysHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDentistryPeriodonticsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Dentistry

Study Officials

  • Afsheen Mansoor

    Pakistan Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 22, 2024

Study Start

February 3, 2023

Primary Completion

February 4, 2024

Study Completion

February 4, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations