PeriodontitisNCT07668947
Impact of E-Cigarette Smoking on Healing Response to Non-Surgical Periodontal Therapy
A study testing non surgical periodontal therapy in people with Periodontitis, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- non surgical periodontal therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Oct 2025to 4 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry , Ain shams university
Cairo, Cairo Governorate, 11566
About this study
Official 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 )
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?
Read the 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.
- Conditions
- Periodontitis
- Being tested
- non surgical periodontal therapy
- Keywords
- periodontitis, smoking, e-cigarette, GCF
- Medical subject headings
- Periodontitis, Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non surgical periodontal therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| traditional smokers | Active comparator | patients with stage II periodotitis who are conventional cigarette smokers and recieved non surgical periodontal therapy Receives: 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 Receives: Procedure: non surgical periodontal therapy |
| non smokers | Active comparator | pts with stage II periodontitis who are non smokers and recieved non surgical periodontal therapy Receives: Procedure: non surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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 )
Measured: 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.
Measured: baseline and 2 months follow up after NSPT
Secondary outcomes (2)
interleukin-1B level in GCF
assessment of IL-1B level in GCF using ( ELISA ). results will be expressed according to assay manufacturer's instructions
Measured: 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
Measured: baseline and 2 month after NSPT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start13 Oct 2025
- Primary completion21 Dec 2025
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed M Al Bahrawy, Assoc. pro, Principal investigator, faculty of dentistry ,Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668947
- Sponsor's protocol ID
- 1449
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect participant confidentiality and due to ethical considerations. only summarized and deidentified data will be published
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 )
- ClinicalTrials.gov ID
- NCT07668947
- Acronym / sponsor ID
- 1449
- Conditions
- Periodontitis
- Keywords
- periodontitis, smoking, e-cigarette, GCF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 21 Dec 2025 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| traditional smokers | Active comparator | Procedure: non surgical periodontal therapypatients with stage II periodotitis who are conventional cigarette smokers and recieved non surgical periodontal therapy |
| e-cigarette smokers | Active comparator | Procedure: non surgical periodontal therapypts with stage II periodontitis who are on e-cigarette smoking and recieved non surgical periodontal therapy |
| non smokers | Active comparator | Procedure: non surgical periodontal therapypts with stage II periodontitis who are non smokers and recieved non surgical periodontal therapy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non surgical periodontal therapyparticipants 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. | Procedure or surgery | e-cigarette smokers, non smokers, traditional smokers |
Primary outcome
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
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
plaque index
Time frame: baseline and 2 months follow up after NSPT
assessment of plaque accumulation using plaque index ( Silness and Loe plaque index )
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.
2 secondary outcomes
interleukin-1B level in GCF
Time frame: baseline and 2 months after NSPT
IL-20 level in GCF
Time frame: baseline and 2 month after NSPT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- pubmed articleLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared to protect participant confidentiality and due to ethical considerations. only summarized and deidentified data will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed M Al Bahrawy, Assoc. pro principal investigator
faculty of dentistry ,Ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non surgical periodontal therapy in people with Periodontitis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
probing depth (PD) (time frame: baseline and 2 months follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.