## Protocol Section
### Identification Module
**NCT ID:** NCT06424600

**Brief Title:** Ginglival Health Among Smokers Visiting Dental Hospital

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

#### Organization Study ID Info
**ID:** SOD/ERB/2023/32-02
#### Organization
**Class:** OTHER_GOV
**Full Name:** Pakistan Institute of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2024-02-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-02-04

**Type:** ACTUAL

#### Start Date
**Date:** 2023-02-03

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Pakistan Institute of Medical Sciences

#### Responsible Party

**Investigator Affiliation:** Pakistan Institute of Medical Sciences

**Investigator Full Name:** Afsheen Mansoor

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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. 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 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.

### Conditions Module

**Conditions:**

- Smoking

**Keywords:**

- Gingival

- Smokers

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 300

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Smoke- form users

**Intervention Names:**

- Other: Gingival Index

**Label:** S-form users

#### Arm Group 2

**Description:** E-Cigarette users

**Intervention Names:**

- Other: Gingival Index

**Label:** E-form users

#### Arm Group 3

**Description:** Dual-Form users

**Intervention Names:**

- Other: Gingival Index

**Label:** D-form users

### Interventions

#### Intervention 1

**Arm Group Labels:**

- D-form users

- E-form users

- S-form users

**Description:** 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.

**Name:** Gingival Index

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Gingival Index

**Time Frame:** one year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Smokers with good general health status visiting dental hospital

Exclusion Criteria:

* Non-smoker dental patients

**Healthy Volunteers:** True

**Minimum Age:** 21 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients visiting Dental Outpatient Department with history of Smoking

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Islamabad

**Country:** Pakistan

**Facility:** Afsheen Mansoor

**Zip:** 44080

#### Overall Officials

**Official 1:**

**Affiliation:** Pakistan Institute of Medical Sciences

**Name:** Afsheen Mansoor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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:** 31538806

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12478

- Name: Nicotine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
