Periodontitis
Conditions
Keywords
periodontitis, smoking, e-cigarette, GCF
Brief summary
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?
Detailed description
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.
Interventions
PROCEDUREnon surgical periodontal therapy
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.
Sponsors
Ain Shams University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* pts aged 20-40 years * pts with stage II periodontitis * systemically healthy with no chronic diseases * no current use of medication * participants have the same socioeconomic status * participants must be able to understand and comply with the study protocol and give informed consent
Exclusion criteria
* pts with severe systemic diseases * recent use of immunosuppressants or medications that affect oral health * history of illicit drug use within the past 12 months * periodontal surgery or scaling within the last 6 months * participants in another clinical trial * vulnerable individuals as children and pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| probing depth (PD) | baseline and 2 months follow up | 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 |
| clinical attachment loss | baseline and 2 months follow up after non surgical periodontal surgery | 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 |
| plaque index | baseline and 2 months follow up after NSPT | assessment of plaque accumulation using plaque index ( Silness and Loe plaque index ) |
| bleeding on probing | baseline and 2 months follow up after NSPT | assessment of gingival bleeding following periodontal probing and recorded as the percentage of bleeding sites. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| interleukin-1B level in GCF | baseline and 2 months after NSPT | assessment of IL-1B level in GCF using ( ELISA ). results will be expressed according to assay manufacturer's instructions |
| IL-20 level in GCF | baseline and 2 month after NSPT | assessment of IL-20 levels in GCF samples using (ELISA ). results will be expressed according to assay manufacturer's instructions |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMohamed M Al Bahrawy, Assoc. pro
faculty of dentistry ,Ain shams university
Outcome results
None listed