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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2025-04-30

Brief Summary

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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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Detailed Description

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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

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Smoking ( Cigarette) Periodontitis Stage II

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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smoker with periodontitis

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

Group Type ACTIVE_COMPARATOR

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%)

Intervention Type PROCEDURE

scaling , curettage and root planning

Non-smokers with periodontitis

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

Group Type ACTIVE_COMPARATOR

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%)

Intervention Type PROCEDURE

scaling , curettage and root planning

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.