SmokingNCT06424600
Ginglival Health Among Smokers Visiting Dental Hospital
An observational study of Smoking, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 voluntarily participated in this study. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Gingival Index
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Feb 2023to 4 Feb 2024
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients visiting Dental Outpatient Department with history of Smoking
Who may be able to join
- Smokers with good general health status visiting dental hospital
Who cannot join
- Non-smoker dental patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Gingival Index
- Keywords
- Gingival, Smokers
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival IndexOther
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.
| Study group | Role | What they receive |
|---|---|---|
| S-form users | Smoke- form users Receives: Other: Gingival Index | |
| E-form users | E-Cigarette users Receives: Other: Gingival Index | |
| D-form users | Dual-Form users Receives: Other: Gingival Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start3 Feb 2023
- Primary completion4 Feb 2024
- Study completion4 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Afsheen Mansoor, Pakistan Institute of Medical Sciences
- Investigators
- Afsheen Mansoor, Principal investigator, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424600
- Sponsor's protocol ID
- SOD/ERB/2023/32-02
- Status last verified
- Jun 2024
- First submitted
- 16 May 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31538806
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Various Forms of Nicotine Consumption on Gingival Health of Dental Patients.
- ClinicalTrials.gov ID
- NCT06424600
- Acronym / sponsor ID
- SOD/ERB/2023/32-02
- Conditions
- Smoking
- Keywords
- Gingival, Smokers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 4 Feb 2024 (actual)
- Study completion
- 4 Feb 2024 (actual)
- First posted
- 22 May 2024 (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 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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| S-form users | – | Other: Gingival IndexSmoke- form users |
| E-form users | – | Other: Gingival IndexE-Cigarette users |
| D-form users | – | Other: Gingival IndexDual-Form users |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting Dental Outpatient Department with history of Smoking
Key inclusion criteria (1 listed)
- Smokers with good general health status visiting dental hospital
Key exclusion criteria (1 listed)
- Non-smoker dental patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gingival IndexThe 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. | Other | D-form users, E-form users, S-form users |
Primary outcome
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.
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 25 Jun 2024.
- Background: PubMed 31538806Tomar 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.
- 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.
Afsheen Mansoor principal investigator
Pakistan Institute of Medical Sciences
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 Smoking, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 1 inclusion and 1 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 25 Jun 2024. 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 Pakistan. 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?
Gingival Index (time frame: one 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 NCT06424600, which also lists 1 linked publication.
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 25 Jun 2024.