Impact of E-Cigarette Smoking on Healing Response to Non-Surgical Periodontal Therapy

Impact of E-Cigarette Smoking on Healing Response to Non-Surgical Periodontal Therapy in the Management of Stage II Periodontitis (A Randomized Controlled Clinical Study With Biochemical Assessment )

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?

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: non surgical periodontal therapy

Detailed Description

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? .A randomized controlled clinical trial will be conducted on patients with periodontitis stage II . participants will be allocated to one of three groups: traditional smokers , vapers and non-smokers . the randomization process will ensure unbiased distribution of participants across the groups . periodontal health will be evaluated through clinical assesment ( probing depth as primary outcome, clinical attachemt level, bleeding on probing and GI ) then cytokine levels (IL-1B , IL-20) will be assessed.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11566
      • faculty of dentistry , Ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: traditional smokers; patients with stage II periodotitis who are conventional cigarette smokers and recieved non surgical periodontal therapy	Procedure: non surgical periodontal therapy; 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.
Active Comparator: e-cigarette smokers; pts with stage II periodontitis who are on e-cigarette smoking and recieved non surgical periodontal therapy	Procedure: non surgical periodontal therapy; 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.
Active Comparator: non smokers; pts with stage II periodontitis who are non smokers and recieved non surgical periodontal therapy	Procedure: non surgical periodontal therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
interleukin-1B level in GCF	assessment of IL-1B level in GCF using ( ELISA ). results will be expressed according to assay manufacturer's instructions	baseline and 2 months after NSPT
IL-20 level in GCF	assessment of IL-20 levels in GCF samples using (ELISA ). results will be expressed according to assay manufacturer's instructions	baseline and 2 month after NSPT

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Mohamed M Al Bahrawy, Assoc. pro, faculty of dentistry ,Ain shams university

Publications and helpful links

Helpful Links

• pubmed article

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2025
• Primary Completion (Actual): December 21, 2025
• Study Completion (Actual): March 4, 2026

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 20, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: smoking; periodontitis; e-cigarette; GCF
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavior; Periodontitis; Smoking; Vaping
• Other Study ID Numbers: 1449 (CSL Behring)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared to protect participant confidentiality and due to ethical considerations. only summarized and deidentified data will be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No