NCT07562295

Brief Summary

This study compares the different effects of traditional cigarettes, e-cigarettes, and narghile on periodontal health among a sample of Al-Hawash Private University students. The main question it aims to answer is: Are there statistically significant differences in periodontal parameters among different types of smokers?

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Jun 2025Aug 2026

Study Start

First participant enrolled

June 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

May 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

April 25, 2026

Last Update Submit

April 25, 2026

Conditions

Keywords

SmokingCigarettesPeriodontal HealthElectronic CigarettesNarghile Smokers

Outcome Measures

Primary Outcomes (8)

  • Plaque Index (PI)

    Plaque Index (PI) The PI was evaluated according to the Silness and Löe (1964) system. This system assesses the plaque thickness at the tooth cervical margin (closest to the gum) and has four scores: 0: no plaque; 1. a film of plaque adhering to the free gingival margin which is nonvisible and it can be scraped from the tooth surface using a probe; 2. moderate accumulation of soft deposits within the gingival pocket or between the tooth and the gingival margin; 3. abundance of soft matter within the gingival pocket and/or on the tooth and the gingival margin. The presence of visible dental plaque was recorded on the four sites (vestibular, lingual, mesial, and distal) of all the teeth, except the third molars. three PI classes (PI%; \[0-1\[; \[1-2\[; \[2-3\]) were arbitrarily defined

    At enrollment

  • Gingival Index (GI)

    The gingival status was evaluated using the method of Löe and Silness (1963). The GI score perfectly evaluates the marginal and inter proximal tissues separately on the basis of the following three criteria (Löe \& Silness, 1963): 0: no inflammation, healthy gingiva; 1. mild inflammation, slight change in color, slight edema, no bleeding on pressure; 2. moderate inflammation, moderate glazing, red ness, bleeding on pressure; 3. severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.

    At enrollment

  • Probing Pocket Depth (PPD)

    PPD is the distance between the gingival margin and the apical depth of the periodontal probe tip penetration. The depth of the sulci or pockets was probed using a Williams periodontal probe with markings 1, 2, 3, 5,7,8, 9, 10 mm. The clinical measurements were based on the four sites (buccal, mesial, distal, and lingual) of all the teeth, except the third molars (Natto et al., 2005b).

    At enrollment

  • Clinical Attachment Level (CAL)

    Clinical attachment level (CAL) is measured from the cementoenamel junction to the bottom of the sulcus or pocket at the four sites. The mean is then calculated for each patient.

    At enrollment

  • Bleeding On Probing (BOP)

    The bleeding on probing was assessed through gentle probing of the orifice of the gingival crevice .If bleeding occurs within 10 seconds, a positive finding was established and the number of positive sites was recorded and then expressed as the percentage of the number of sites examined.

    At enrollment

  • Tooth Mobility (TM)

    Tooth mobility, was performed by alternatively pressing on the tooth buccal and lingual surfaces using one finger and one metallic instrument Tooth mobility was recorded (Fleszar et al., 1980) as follows: 0: physiologic mobility, firm tooth; 1. slightly increased mobility; 2. definite to considerable increase in mobility but no function impairment; 3. extreme mobility, a loose tooth that would be incomparable in function

    At enrollment

  • Gingival Recession (GR)

    Gingival recession is measured by measuring the distance from the cementoenamel junction to the free gingival margin at the midpoint of the buccal surface.

    At enrollment

  • Furcation Involvement ( FI)

    Furcation involvement, is investigated clinically with a probe and classified according to the Hamp's classification system: Class 0 = no horizontal loss of periodontal tissue support (apart from the original scoring scale). Class I ≤3mm horizontal loss of periodontal tissue support. Class II \> 3 mm horizontal loss of periodontal tissue support, no through-and-through furcation Class III through-and-through furcation (required to see the tip of the probe at the contralateral furcation opening) and additionally

    At enrollment

Study Arms (3)

Cigarette Smokers

Other: Non-Interventional Study

E-cigarette Smokers

Other: Non-Interventional Study

Narghile Smokers

Other: Non-Interventional Study

Interventions

Non-Interventional Study

Cigarette SmokersE-cigarette SmokersNarghile Smokers

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Smoker students at Al-Hawash Private University

You may qualify if:

  • Cigarette smokers: Individuals who have smoked five or more cigarettes per day for at least one year.
  • E-cigarette smokers: Individuals who have smoked e-cigarettes one or more times per day for at least one year.
  • narghile smokers: Individuals who have used a hookah one or more times per day for at least one year.

You may not qualify if:

  • Non-smokers
  • Ages older than 25 years
  • Dual smokers: Individuals who smoke two or more types of tobacco.
  • Individuals with systemic diseases, such as diabetes, heart disease, liver problems, and kidney disease
  • Individuals who reported using antibiotics, steroids, or NSAIDs within the past month
  • Individuals who have received periodontal treatment at least six months ago

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Hawash Private University

Homs, Homs Governorate, 0000, Syria

RECRUITING

MeSH Terms

Conditions

SmokingVaping

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Ali Abou Sulaiman, Ph.D. in Periodontology

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2026

First Posted

May 1, 2026

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

May 1, 2026

Record last verified: 2026-03

Locations