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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis Stage II; Smoking ( Cigarette)
• Intervention / Treatment: 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%)

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: smoker with periodontitis; patients with stage II periodontitis who are current smoker and will receive non-surgical periodontal therapy	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%); scaling , curettage and root planning
Active Comparator: Non-smokers with periodontitis; patients with stage II periodontitis who have never smoked and will receive Non-surgical therapy	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%); scaling , curettage and root planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline and 6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Probing Pocket Depth	Measurement of the depth of the gum pockets using a periodontal probe to assess clinical healing.	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.	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.	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).	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.	Baseline, 3 and 6 months after treatment.

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Manar Morsi Morsi, MSc, Faculty of Dental Medicine for Girls, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Actual): April 11, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavior; Smoking; Tobacco Smoking; Tobacco Use; Periodontitis; Cigarette Smoking; Organic Chemicals; Lipids; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Alcohols; Cyclohexanols; Hexanols; Fatty Alcohols; Cyclohexane Monoterpenes; Monoterpenes; Ethanol; Listerine; Menthol; Thymol; methyl salicylate
• Other Study ID Numbers: OMPDR_105_1r

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

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