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Completed

NCT Number: NCT07668947

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

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?

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Key information

Conditions

Periodontitis Behavior Mouth Diseases Periodontal Diseases Smoking Stomatognathic Diseases Vaping

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry , Ain shams university

Cairo, Cairo Governorate, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non surgical periodontal therapy

Procedure

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.

Primary outcomes

  1. probing depth (PD)

    Time frame: baseline and 2 months follow up

    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

  2. clinical attachment loss

    Time frame: baseline and 2 months follow up after non surgical periodontal surgery

    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

  3. plaque index

    Time frame: baseline and 2 months follow up after NSPT

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

  4. bleeding on probing

    Time frame: baseline and 2 months follow up after NSPT

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

Secondary outcomes

  1. interleukin-1B level in GCF

    Time frame: baseline and 2 months after NSPT

    assessment of IL-1B level in GCF using ( ELISA ). results will be expressed according to assay manufacturer's instructions

  2. IL-20 level in GCF

    Time frame: baseline and 2 month after NSPT

    assessment of IL-20 levels in GCF samples using (ELISA ). results will be expressed according to assay manufacturer's instructions

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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 )

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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