Smoking ( Cigarette)NCT07339670

Study of Gum Tissue Proteins in Smokers vs. Non-smokers After Cleaning

A study testing Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) in people with Smoking ( Cigarette) and Periodontitis Stage II, run by Al-Azhar University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 40 years
Conditions the study is for: Smoking ( Cigarette), Periodontitis Stage II
What is being tested?: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteEgypt
Study dates: 11 Nov 2024to 30 Apr 2025
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 25 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female aged from 25 - 40 years old.
Patients diagnosed as having Stage II periodontitis.
Group of current smoker's patients, more than 10 cigarettes per day.
Group of non-smoker's patients.
Maximum probing depth ≤ 5 mm, mostly horizontal bone loss.
Clinical Attachment loss from 3-4 mm.
Radiographic bone loss about 15% to 33%, mostly horizontal.

Who cannot join

Pregnant or lactating women.
Any known systemic disease.
Patients who received periodontal treatment in last 6 months.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo, Nasr City, 4450113

Other trials in Egypt

About this study

Official title: Effect of Smoking on the Expression of Periodontal Ligament -Associated Protien-1 and Sclerostin in Gingival Crevicular Fluid of Stage II Periodontitis Patients After Non-Surgical Periodontal t\Therapy

The aim of this study is to evaluate how smoking affects the healing process of the gums after treatment. The researchers will measure the levels of two specific proteins (PLAP-1 and Sclerostin) in the gum fluid of patients with stage II periodontitis. These measurements will be compared between smokers and non-smokers before and after receiving non-surgical periodontal therapy (cleaning and scaling) to see if smoking changes the body's response to treatment.

Read the detailed description

Patients diagnosed with Stage II Periodontitis will be recruited and divided into two groups: Group I (current smokers) and Group II (non-smokers). At the beginning of the study (baseline), clinical periodontal parameters will be recorded, including probing depth, clinical attachment level, and plaque index. Gingival Crevicular Fluid (GCF) samples will be collected from the most affected sites using paper strips.

Following the initial assessment, all participants will undergo non-surgical periodontal therapy consisting of full-mouth scaling and root planing (SRP) using ultrasonic and hand instruments. Oral hygiene instructions will be provided to all patients.

Patients will be re-evaluated after 6 months following the treatment. Clinical parameters will be re-recorded, and GCF samples will be collected again. The samples will then be analyzed using Enzyme-Linked Immunosorbent Assay (ELISA) to determine the concentration levels of Periodontal Ligament Associated Protein-1 (PLAP-1) and Sclerostin. The study aims to correlate these protein levels with the clinical healing outcomes in both smokers and non-smokers.

Conditions: Smoking ( Cigarette), Periodontitis Stage II
Being tested: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)
Medical subject headings: Cigarette Smoking, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)Procedure or surgery
scaling , curettage and root planning

Study groups in NCT07339670
Study group	Role	What they receive
smoker with periodontitis	Active comparator	patients with stage II periodontitis who are current smoker and will receive non-surgical periodontal therapy Receives: Procedure: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)
Non-smokers with periodontitis	Active comparator	patients with stage II periodontitis who have never smoked and will receive Non-surgical therapy Receives: Procedure: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)

What is being measured

The primary outcome is the main question the study is designed to answer.

change in periodontal ligament associated protien-1 levels
Concentration of PLAP-1 measured in Gingival Crevicular Fluid (GCF) using ELISA technique. This protein reflects the status of the periodontal ligament.
Measured: Baseline (before treatment) and 6 months after treatment
Change in Sclerostin levels
Concentration of Sclerostin measured in Gingival Crevicular Fluid (GCF) to evaluate bone remodeling activity.
Measured: Baseline and 6 months after treatment

Secondary outcomes (5)

Change in Probing Pocket Depth
Measurement of the depth of the gum pockets using a periodontal probe to assess clinical healing.
Measured: Baseline , 3 and 6 months after treatment
Change in Clinical Attachment Level
Measurement of the distance from the cemento-enamel junction to the bottom of the pocket to assess tissue attachment gain.
Measured: Baseline , 3 and 6 months after treatment
Change in Plaque Index (PI).
Evaluation of the amount of plaque on tooth surfaces using the Silness and Löe Plaque Index. Scores range from 0 (no plaque) to 3 (abundance of soft matter). Lower scores indicate better oral hygiene.
Measured: Baseline , 3 and 6 months after treatment.
Change in Gingival Index (GI).
Assessment of the severity of gingival inflammation using the Löe and Silness Gingival Index. Scores range from 0 (normal gingiva) to 3 (severe inflammation, tendency to spontaneous bleeding).
Measured: Baseline, 3 and 6 months after treatment.
Change in Bleeding on Probing (BOP) percentage.
Presence or absence of bleeding recorded within 30 seconds after probing. It is calculated as the percentage of sites that bleed upon probing relative to the total number of sites probed.
Measured: Baseline, 3 and 6 months after treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 202430 Apr 2025

First posted14 Jan 2026
Study start11 Nov 2024
Primary completion11 Apr 2025
Study completion30 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Smoking ( Cigarette)Studies of the same condition, open and under way.
More trials run by Al-Azhar 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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07339670
Sponsor's protocol ID: OMPDR_105_1r
Status last verified: Jan 2026
First submitted: 5 Jan 2026
Last updated: 14 Jan 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The individual participant data will not be available to preserve patient confidentiality and because the informed consent signed by participants did not include a provision for public data sharing

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Smoking on the Expression of Periodontal Ligament -Associated Protien-1 and Sclerostin in Gingival Crevicular Fluid of Stage II Periodontitis Patients After Non-Surgical Periodontal t\Therapy
ClinicalTrials.gov ID: NCT07339670
Acronym / sponsor ID: OMPDR_105_1r
Conditions: Smoking ( Cigarette), Periodontitis Stage II
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Al-Azhar UniversityUniversity, hospital or other
Study start: 11 Nov 2024 (actual)
Primary completion: 11 Apr 2025 (actual)
Study completion: 30 Apr 2025 (actual)
First posted: 14 Jan 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.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
smoker with periodontitis	Active comparator	Procedure: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)patients with stage II periodontitis who are current smoker and will receive non-surgical periodontal therapy
Non-smokers with periodontitis	Active comparator	Procedure: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)patients with stage II periodontitis who have never smoked and will receive Non-surgical therapy

Who may qualify

Ages: 25 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Male or female aged from 25 - 40 years old.
Patients diagnosed as having Stage II periodontitis.
Group of current smoker's patients, more than 10 cigarettes per day.
Group of non-smoker's patients.
Maximum probing depth ≤ 5 mm, mostly horizontal bone loss.

Key exclusion criteria (3 listed)

Pregnant or lactating women.
Any known systemic disease.
Patients who received periodontal treatment in last 6 months.

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 Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)scaling , curettage and root planning	Procedure or surgery	Non-smokers with periodontitis, smoker with periodontitis

Primary outcome

change in periodontal ligament associated protien-1 levels
Time frame: Baseline (before treatment) and 6 months after treatment
Concentration of PLAP-1 measured in Gingival Crevicular Fluid (GCF) using ELISA technique. This protein reflects the status of the periodontal ligament.
Change in Sclerostin levels
Time frame: Baseline and 6 months after treatment
Concentration of Sclerostin measured in Gingival Crevicular Fluid (GCF) to evaluate bone remodeling activity.

5 secondary outcomes

Change in Probing Pocket Depth
Time frame: Baseline , 3 and 6 months after treatment
Change in Clinical Attachment Level
Time frame: Baseline , 3 and 6 months after treatment
Change in Plaque Index (PI).
Time frame: Baseline , 3 and 6 months after treatment.
Change in Gingival Index (GI).
Time frame: Baseline, 3 and 6 months after treatment.
Change in Bleeding on Probing (BOP) percentage.
Time frame: Baseline, 3 and 6 months after treatment.

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 14 Jan 2026.
Individual participant dataSharing planned: No. The individual participant data will not be available to preserve patient confidentiality and because the informed consent signed by participants did not include a provision for public data sharing

Related trials for Smoking ( Cigarette)

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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Enrolling by invitationObservational study
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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.

Manar Morsi Morsi, MSc study director

Faculty of Dental Medicine for Girls, Al-Azhar University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 3 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 14 Jan 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?

change in periodontal ligament associated protien-1 levels (time frame: Baseline (before treatment) and 6 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07339670.

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 14 Jan 2026.