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

Al-Azhar University

Status: Completed

Conditions: Smoking ( Cigarette); Periodontitis Stage II

Treatments: 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%)

Study type: Interventional

Funder types: Other

Identifiers

NCT07339670

OMPDR_105_1r

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 25 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

smoker with periodontitis

Active Comparator group

Description:

patients with stage II periodontitis who are current smoker and will receive non-surgical periodontal therapy

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%)

Non-smokers with periodontitis

Active Comparator group

Description:

patients with stage II periodontitis who have never smoked and will receive Non-surgical therapy

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%)