Effect of Smoking Cessation on Salivary IL-1β and PGE-2 Levels Following Non-Surgical Periodontal Therapy

Not Applicable

Completed

• Conditions: Periodontal Diseases; Smoking Cessation
• Interventions: Procedure: Minimally invasive non-surgical periodontal therapy; Procedure: Conventional non-surgical periodontal therapy

• Registration Number: NCT06145685
• Lead Sponsor: October 6 University

Brief Summary

The aim of this study is to evaluate the effect of smoking cessation on inflammatory markers following non-surgical treatment of periodontal disease. This is to assess the period of smoking abstinence needed before any periodontal surgery in order to reverse the negative effects of the reported increased levels of inflammatory markers (IL-1β and PGE2 in this study) associated with smoking on the healing and the periodontium.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2023-11
• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2023-11-22
• Last Update Submitted: 2023-11-22
• Study First Posted: 2023-11-24
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with advanced chronic periodontitis upon clinical examination with clinical attachment loss (CAL) more than 5 mm.
• Patients willing to quit smoking to be included in two groups, while patients unwilling to quit smoking to be included in the third group, and the non-smokers as the fourth group.

Exclusion Criteria

• Any systemic illness known to affect the outcome.
• Systemic antimicrobial or anti-inflammatory drug therapy within the last 3 months prior to the study.
• Patients unable to perform routine oral hygiene procedures.
• Patients using other forms of tobacco.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Previous smokers - Minimally invasive	Minimally invasive non-surgical periodontal therapy	Minimally invasive non-surgical periodontal treatment
Previous smokers - Conventional	Conventional non-surgical periodontal therapy	Conventional non-surgical periodontal treatment
Smoker	Conventional non-surgical periodontal therapy	Conventional non-surgical periodontal treatment
Non-smoker	Conventional non-surgical periodontal therapy	Conventional non-surgical periodontal treatment

Primary Outcome Measures

Name	Time	Method
Interleukin 1 beta (in PG/ml)	Baseline and 2 months	Salivary biochemical analysis
Levels of Prostaglandin E2	Baseline and 2 months	Salivary biochemical analysis

Secondary Outcome Measures

Name	Time	Method
Pocket depth (in mm)	Baseline and 9 months	Periodontal clinical parameter
clinical attachment level (in mm)	Baseline and 9 months	Periodontal clinical parameter
Periodontal clinical parameters	Baseline and 9 months	Gingival index (scores)
Plaque index (scores)	Baseline and 9 months	Periodontal clinical parameters
bone gain (in mm)	Baseline and 9 months	Periodontal clinical parameter

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt