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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07339670
Enrollment
36
Registered
2026-01-14
Start date
2024-11-11
Completion date
2025-04-30
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking ( Cigarette), Periodontitis Stage II

Brief summary

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.

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.

Interventions

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in Plaque Index (PI).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.
Change in Probing Pocket DepthBaseline , 3 and 6 months after treatmentMeasurement of the depth of the gum pockets using a periodontal probe to assess clinical healing.
Change in Bleeding on Probing (BOP) percentage.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.
Change in Gingival Index (GI).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).
Change in Clinical Attachment LevelBaseline , 3 and 6 months after treatmentMeasurement of the distance from the cemento-enamel junction to the bottom of the pocket to assess tissue attachment gain.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026