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Clinical Trials/NCT07339670
NCT07339670CompletedNot Applicable

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 site in 1 country36 target enrollmentStarted: November 11, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
change in periodontal ligament associated protien-1 levels

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
25 Years to 40 Years (Adult)
Sex
All
Accepts 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.

Arms & Interventions

smoker with periodontitis

Active Comparator

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

Intervention: 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

Intervention: 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)

Outcomes

Primary Outcomes

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.

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

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Manar Morsi elsaied morsi

dentist

Al-Azhar University

Study Sites (1)

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