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the goal of this clinical trial is to compare the effect of vaping vs traditional smoking on non surgical periodontal therapy . the main question it aims to answer is what is the impact of traditional smoking and vaping on periodontal health and how do IL-1B and IL-20 serve as mediators in the inflammatory processes linked to periodontal disease?
the goal of this clinical trial is to compare the effect of vaping vs traditional smoking on non surgical periodontal therapy . the main question it aims to answer is what is the impact of traditional smoking and vaping on periodontal health and how do IL-1B and IL-20 serve as mediators in the inflammatory processes linked to periodontal disease? .A randomized controlled clinical trial will be conducted on patients with periodontitis stage II . participants will be allocated to one of three groups: traditional smokers , vapers and non-smokers . the randomization process will ensure unbiased distribution of participants across the groups . periodontal health will be evaluated through clinical assesment ( probing depth as primary outcome, clinical attachemt level, bleeding on probing and GI ) then cytokine levels (IL-1B , IL-20) will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| traditional smokers | Active Comparator | patients with stage II periodotitis who are conventional cigarette smokers and recieved non surgical periodontal therapy |
|
| e-cigarette smokers | Active Comparator | pts with stage II periodontitis who are on e-cigarette smoking and recieved non surgical periodontal therapy |
|
| non smokers | Active Comparator | pts with stage II periodontitis who are non smokers and recieved non surgical periodontal therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non surgical periodontal therapy | Procedure | participants in all groups will recieve non surgical periodontal therapy including scaling and root planning performed using ultrasonic and hand instruments at baseline. oral hygiene instructions will be provided. periodontal parameters and GCF samples will be collected at baseline and follow up visit. |
| Measure | Description | Time Frame |
|---|---|---|
| probing depth (PD) | assessment of periodontal probing depth measured in millimeters using a UNC -15 periodontal probe. PD will be measured from the gingival margin to the base of the periodontal pocket at six sites per tooth | baseline and 2 months follow up |
| clinical attachment loss | assessment of CAL measured in millimeters using a UNC-15 periodontal probe. CAL will be measured from (CEJ) to the base of the pocket at 6 sites per tooth | baseline and 2 months follow up after non surgical periodontal surgery |
| plaque index | assessment of plaque accumulation using plaque index ( Silness and Loe plaque index ) | baseline and 2 months follow up after NSPT |
| bleeding on probing | assessment of gingival bleeding following periodontal probing and recorded as the percentage of bleeding sites. | baseline and 2 months follow up after NSPT |
| Measure | Description | Time Frame |
|---|---|---|
| interleukin-1B level in GCF | assessment of IL-1B level in GCF using ( ELISA ). results will be expressed according to assay manufacturer's instructions | baseline and 2 months after NSPT |
| IL-20 level in GCF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed M Al Bahrawy, Assoc. pro | faculty of dentistry ,Ain shams university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of dentistry , Ain shams university | Cairo | Cairo Governorate | 11566 | Egypt |
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| Label | URL |
|---|---|
| pubmed article | View source |
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IPD will not be shared to protect participant confidentiality and due to ethical considerations. only summarized and deidentified data will be published
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D012907 | Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001519 | Behavior |
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assessment of IL-20 levels in GCF samples using (ELISA ). results will be expressed according to assay manufacturer's instructions
| baseline and 2 month after NSPT |