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Completed

NCT Number: NCT07339670

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

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.

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Key information

Conditions

Smoking ( Cigarette) Behavior Cigarette Smoking Mouth Diseases Periodontal Diseases Periodontitis Periodontitis Stage II Smoking Stomatognathic Diseases Tobacco Smoking Tobacco Use

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Nasr City, 4450113, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

scaling , curettage and root planning

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in Probing Pocket Depth

    Time frame: Baseline , 3 and 6 months after treatment

    Measurement of the depth of the gum pockets using a periodontal probe to assess clinical healing.

  2. Change in Clinical Attachment Level

    Time frame: Baseline , 3 and 6 months after treatment

    Measurement of the distance from the cemento-enamel junction to the bottom of the pocket to assess tissue attachment gain.

  3. Change in Plaque Index (PI).

    Time frame: Baseline , 3 and 6 months after treatment.

    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.

  4. Change in Gingival Index (GI).

    Time frame: Baseline, 3 and 6 months after treatment.

    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).

  5. Change in Bleeding on Probing (BOP) percentage.

    Time frame: Baseline, 3 and 6 months after treatment.

    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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2026
Registry last updated
Jan 14, 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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