The Effect of Scaling and Root Planing on Oral Inflammatory Biomarkers Among E-cig Users and Non-smokers
ENDS-SRP
1 other identifier
interventional
100
1 country
1
Brief Summary
Background/Aim: There are no studies that have compared the gingival crevicular fluid (GCF) levels of IL-1β in non-smokers (NS) and electronic nicotine delivery system (ENDS)-users before and after scaling and root planing (SRP) in patients with gingivitis. The aim of the present study is to compare the effect of scaling and root planing on the expression of IL-1β in the GCF among ENDS-users and NS clinically. Methods: Self-reported current ENDS users and NS would be included. A questionnaire would be used to collect demographic data. All patients would undergo SRP. Clinical measures, periodontal parameters \[probing depth (PD), plaque index (PI), and bleeding on probing (BOP)\], and GCF IL-1β would be measured at baseline. At 1-week (T1) and 3 weeks (T2) of follow-up, periodontal parameters and GCF IL-1β levels would be re-assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 16, 2023
CompletedFirst Posted
Study publicly available on registry
February 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJuly 8, 2024
July 1, 2024
2 years
February 16, 2023
July 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Attachment Level
Level of gingival attachment would be assessed
3 months
Study Arms (4)
Smoker vs Nonsmokers
EXPERIMENTALSRP would be performed for Smokers (ENDS and conventional cigarette) and Nonsmokers and their inflammatory biomarkers would be assessed.
ENDS users and Nonsmokers
EXPERIMENTALSRP would be performed for ENDS users and Nonsmokers and their inflammatory biomarkers would be assessed.
Smokers with periodontitis and Nonsmokers
EXPERIMENTALSRP would be performed for Smokers with periodontitis and health nonsmokers and their inflammatory biomarkers would be assessed.
Smokers with periodontitis and Nonsmokers with periodontitis
EXPERIMENTALSRP would be performed for Smokers and Nonsmokers with periodontitis and their inflammatory biomarkers would be assessed.
Interventions
SRP is cleaning the sub gingival and supra gingival plaque and calculus from the teeth
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry
Kuwait City, 13110, Kuwait
Related Publications (1)
Alkhalifah AB, Alfuraih NT, Joseph B, Baskaradoss JK. Effect of scaling on levels of interleukin 1-beta and clinical periodontal parameters among e-cigarette users and non-smokers: A prospective study. Tob Induc Dis. 2024 Jul 10;22:10.18332/tid/189552. doi: 10.18332/tid/189552. eCollection 2024.
PMID: 38988743DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The investigators, care providers and outcome assessors would be blinded to the smoking status of the participants
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 16, 2023
First Posted
February 27, 2023
Study Start
June 1, 2021
Primary Completion
June 1, 2023
Study Completion
December 1, 2023
Last Updated
July 8, 2024
Record last verified: 2024-07