The Effect of Scaling and Root Planing on Oral Inflammatory Biomarkers Among E-cig Users and Non-smokers (ENDS-SRP)

The Effect of Scaling and Root Planing on Gingival Crevicular Fluid and Salivary Levels of Inflammatory Biomarkers Among Electronic Nicotine Delivery Systems User, Smokers and Non-Smokers

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Periodontal Diseases
• Intervention / Treatment: Procedure: Scaling and root planing

Detailed Description

2.1. Ethical approval Ethical approval was obtained from the Ethics Committee of Health Sciences Center at Kuwait University. All volunteering individuals were requested to read and sign a consent form written in simple English and Arabic.

2.2. Study Area/Setting The present longitudinal study was conducted between November 2021 and September 2022 at the Kuwait University Dental Center (KUDC). The study participants were regular patients attending the KUDC and the sampling design was convenience sampling.

2.3. Selection Criteria The inclusion criteria: ENDS-users, non-smokers, age (18-25), gender (men), periodontal health status (gingivitis), having minimum number of 20 teeth, and medically healthy. The exclusion criteria: Patients who did scaling and root planing in the past 3 months, T-cigs smokers, and dual smokers.

2.4. Data Collection Methods, Instrument Used, Measurements A standardized questionnaire including a consent form was used to gather information regarding gender, age (in years), nationality, marital status, highest level of education, oral hygiene status, last dental visit, last time that scaling and root planing was done, smoking status, type of smoked product, duration of ENDS usage (in years), frequency of ENDS usage per day, number of ENDS puffs taken per session, family smoking history, exposure to secondhand smoke, general health status, and attitude towards smoking.

2.5. Blinding

2.6. Study Participants Twenty current ENDS-users and eighteen NS were recruited to participate in this study. All participants were requested to refrain from eating and using any oral hygiene method for at least 3 hours prior to their visit.

2.7. Sample Collection For screening of subjects for their use of tobacco products, saliva was collected and tested for the content of nicotine using chairside test kits (NicAlert, Confirm Bioscience, CA, USA). Unstimulated saliva (UWS) was collected before clinical assessment using non-invasive techniques. Prior to salivary and GCF samples collection, each participant's vital signs were measured and recorded. The participants were asked to rinse their mouth with water before a baseline salivary sample is collected to measure cotinine levels. Each participant was asked to collect saliva passively in their mouth and expectorate in a tube every one minute until three millimeters of saliva is collected. The tubes were then stored at -80°C. After that, GCF samples were collected using filter paper strips. GCF will be sampled from four sites at fully erupted, caries-free permanent molars (mesiobuccal and distobuccal of each molar) with gingival index (GI) score of 2 or 3 for gingivitis group. Scaling and root planing was provided for each participant and saliva and GCF samples were obtained in the same manner explained previously after one week and three weeks.

2.8. Power Analysis Power analysis was determined using a computer software (nQuery Advisor 6.0, Statistical Solutions, Saugas, MA., USA) with an alpha and effect size of 0.05 and 0.3, respectively. Sample size estimation was based on the presumption that a mean difference of 1 mm in clinical AL and PD should be detected at a significance-level of 0.05 and a desired study power of at least 80%. It was estimated that a sample size of at least 20 patients/group would achieve 95% study power with a 0.05 two-sided significance-level.

2.9. Analysis of Cotinine and IL-1β in GCF Saliva levels of cotinine was measured to determine the electronic cigarettes status using a high sensitivity, quantitative enzyme immunoassay (ELISA) kit. Then, IL-1β GCF levels was analyzed using commercially available ELISA kit. The difference in the levels of the biomarker before and after the intervention will provide an insight of the soft tissue response to the treatment. This will show the deleterious effect of electronic nicotine delivery systems on the soft tissue response to therapy.

2.10. Clinical Examination In all patients, Löe & Silness gingival index (GI)(Löe and Silness 1963) and Silness & Löe plaque index (PI)(Silness and Löe 1964) were recorded.

2.11. Statistical Analysis Statistical analyses was done using SPSS software (SPSS Version 26, Chicago, IL., USA).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kuwait
  • Kuwait City, Kuwait, 13110
    • Faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The inclusion criteria: ENDS-users, cigarette smokers, non-smokers, age (18-60), gender (men), periodontal health status (gingivitis/periodontitis), having minimum number of 20 teeth, and medically healthy.

Exclusion Criteria:

• The exclusion criteria: Patients who did scaling and root planing in the past 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoker vs Nonsmokers; SRP would be performed for Smokers (ENDS and conventional cigarette) and Nonsmokers and their inflammatory biomarkers would be assessed.	Procedure: Scaling and root planing; SRP is cleaning the sub gingival and supra gingival plaque and calculus from the teeth
Experimental: ENDS users and Nonsmokers; SRP would be performed for ENDS users and Nonsmokers and their inflammatory biomarkers would be assessed.	Procedure: Scaling and root planing; SRP is cleaning the sub gingival and supra gingival plaque and calculus from the teeth
Experimental: Smokers with periodontitis and Nonsmokers; SRP would be performed for Smokers with periodontitis and health nonsmokers and their inflammatory biomarkers would be assessed.	Procedure: Scaling and root planing; SRP is cleaning the sub gingival and supra gingival plaque and calculus from the teeth
Experimental: Smokers with periodontitis and Nonsmokers with periodontitis; SRP would be performed for Smokers and Nonsmokers with periodontitis and their inflammatory biomarkers would be assessed.	Procedure: Scaling and root planing; SRP is cleaning the sub gingival and supra gingival plaque and calculus from the teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Attachment Level	Level of gingival attachment would be assessed	3 months

Collaborators and Investigators

• Sponsor: Kuwait University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: electronic cigarettes
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: VDR/ED/14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No