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临床试验/NCT07339670
NCT07339670已完成不适用

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

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年11月11日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
change in periodontal ligament associated protien-1 levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

smoker with periodontitis

Active Comparator

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

干预措施: 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)

Non-smokers with periodontitis

Active Comparator

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

干预措施: 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)

结局指标

主要结局

change in periodontal ligament associated protien-1 levels

时间窗: 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.

Change in Sclerostin levels

时间窗: Baseline and 6 months after treatment

Concentration of Sclerostin measured in Gingival Crevicular Fluid (GCF) to evaluate bone remodeling activity.

次要结局

  • Change in Probing Pocket Depth(Baseline , 3 and 6 months after treatment)
  • Change in Clinical Attachment Level(Baseline , 3 and 6 months after treatment)
  • Change in Plaque Index (PI).(Baseline , 3 and 6 months after treatment.)
  • Change in Gingival Index (GI).(Baseline, 3 and 6 months after treatment.)
  • Change in Bleeding on Probing (BOP) percentage.(Baseline, 3 and 6 months after treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manar Morsi elsaied morsi

dentist

Al-Azhar University

研究点 (1)

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