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

Study Overview
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Brief Summary
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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.

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

Conditions
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Periodontal Diseases, Smoking Cessation

Intervention / Treatment
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* Procedure: Minimally invasive non-surgical periodontal therapy
* Procedure: Conventional non-surgical periodontal therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Previous smokers - Minimally invasive<br>Minimally invasive non-surgical periodontal treatment | Procedure: Minimally invasive non-surgical periodontal therapy<br>* Minimally invasive non-surgical periodontal therapy<br>|
| Active Comparator: Previous smokers - Conventional<br>Conventional non-surgical periodontal treatment | Procedure: Conventional non-surgical periodontal therapy<br>* Conventional non-surgical periodontal therapy<br>|
| Active Comparator: Smoker<br>Conventional non-surgical periodontal treatment | Procedure: Conventional non-surgical periodontal therapy<br>* Conventional non-surgical periodontal therapy<br>|
| Active Comparator: Non-smoker<br>Conventional non-surgical periodontal treatment | Procedure: Conventional non-surgical periodontal therapy<br>* Conventional non-surgical periodontal therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Prostaglandin E2 | Salivary biochemical analysis | Baseline and 2 months | 
| Interleukin 1 beta (in PG/ml) | Salivary biochemical analysis | Baseline and 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pocket depth (in mm) | Periodontal clinical parameter | Baseline and 9 months | 
| clinical attachment level (in mm) | Periodontal clinical parameter | Baseline and 9 months | 
| bone gain (in mm) | Periodontal clinical parameter | Baseline and 9 months | 
| Plaque index (scores) | Periodontal clinical parameters | Baseline and 9 months | 
| Periodontal clinical parameters | Gingival index (scores) | Baseline and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Periodontal Diseases, Inflammatory Markers, Interleukin-1beta, Prostaglandin E2, Non-surgical therapy, Smoking