NCT07668947

Brief Summary

the goal of this clinical trial is to compare the effect of vaping vs traditional smoking on non surgical periodontal therapy . the main question it aims to answer is what is the impact of traditional smoking and vaping on periodontal health and how do IL-1B and IL-20 serve as mediators in the inflammatory processes linked to periodontal disease?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

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

October 13, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 16, 2026

Last Update Submit

June 28, 2026

Conditions

Keywords

periodontitissmokinge-cigaretteGCF

Outcome Measures

Primary Outcomes (4)

  • probing depth (PD)

    assessment of periodontal probing depth measured in millimeters using a UNC -15 periodontal probe. PD will be measured from the gingival margin to the base of the periodontal pocket at six sites per tooth

    baseline and 2 months follow up

  • clinical attachment loss

    assessment of CAL measured in millimeters using a UNC-15 periodontal probe. CAL will be measured from (CEJ) to the base of the pocket at 6 sites per tooth

    baseline and 2 months follow up after non surgical periodontal surgery

  • plaque index

    assessment of plaque accumulation using plaque index ( Silness and Loe plaque index )

    baseline and 2 months follow up after NSPT

  • bleeding on probing

    assessment of gingival bleeding following periodontal probing and recorded as the percentage of bleeding sites.

    baseline and 2 months follow up after NSPT

Secondary Outcomes (2)

  • interleukin-1B level in GCF

    baseline and 2 months after NSPT

  • IL-20 level in GCF

    baseline and 2 month after NSPT

Study Arms (3)

traditional smokers

ACTIVE COMPARATOR

patients with stage II periodotitis who are conventional cigarette smokers and recieved non surgical periodontal therapy

Procedure: non surgical periodontal therapy

e-cigarette smokers

ACTIVE COMPARATOR

pts with stage II periodontitis who are on e-cigarette smoking and recieved non surgical periodontal therapy

Procedure: non surgical periodontal therapy

non smokers

ACTIVE COMPARATOR

pts with stage II periodontitis who are non smokers and recieved non surgical periodontal therapy

Procedure: non surgical periodontal therapy

Interventions

participants in all groups will recieve non surgical periodontal therapy including scaling and root planning performed using ultrasonic and hand instruments at baseline. oral hygiene instructions will be provided. periodontal parameters and GCF samples will be collected at baseline and follow up visit.

e-cigarette smokersnon smokerstraditional smokers

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pts aged 20-40 years
  • pts with stage II periodontitis
  • systemically healthy with no chronic diseases
  • no current use of medication
  • participants have the same socioeconomic status
  • participants must be able to understand and comply with the study protocol and give informed consent

You may not qualify if:

  • pts with severe systemic diseases
  • recent use of immunosuppressants or medications that affect oral health
  • history of illicit drug use within the past 12 months
  • periodontal surgery or scaling within the last 6 months
  • participants in another clinical trial
  • vulnerable individuals as children and pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry , Ain shams university

Cairo, Cairo Governorate, 11566, Egypt

Location

Related Links

MeSH Terms

Conditions

PeriodontitisSmokingVaping

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBehavior

Study Officials

  • Mohamed M Al Bahrawy, Assoc. pro

    faculty of dentistry ,Ain shams university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 25, 2026

Study Start

October 13, 2025

Primary Completion

December 21, 2025

Study Completion

March 4, 2026

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

IPD will not be shared to protect participant confidentiality and due to ethical considerations. only summarized and deidentified data will be published

Locations