Efficacy of Oral Hygiene Instructions on Proinflammatory Cytokines Among Cigarette Smokers and Individuals Vaping Electronic Cigarettes During Plaque Induced Gingivitis (Clinical Trial)

NCT06177158 | Unknown

• 1 other identifier: vaping effect on biomarkers
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the level of proinflammatory cytokines in individual vaping electronic cigarette in gingivitis patients. Can vaping affects the proinflammatory cytokines level in diseased individuals? Group I: cigarette smoker with gingivitis. Group II: electronic cigarette smoker with gingivitis. Group III: non-smoker with gingivitis. participants will be asked to perform oral hygiene instructions. measurement of inflammatory biomarkers MMP8 and MMP9 base line and after intervention will be done.

Conditions

Electronic Cigarette Use; Plaque Induced Gingivitis

Keywords

smoking; Electronic Cigarette Use; Gingivitis

Outcome Measures

Primary Outcomes (1)

• the reduction in periodontal parameters

  (PI,BOP and GI) between the baseline and the endpoints of the study.

  3 weeks

Secondary Outcomes (1)

• the changes between the baseline and 3 weeks for salivary matrix metalloproteinase 8 and 9 concentration.

  three weeks

Study Arms (3)

cigarette smoker with gingivitis.

ACTIVE COMPARATOR

oral hygiene instructions

Behavioral: oral hygiene instructions

electronic cigarette smoker with gingivitis.

ACTIVE COMPARATOR

oral hygiene instructions

Behavioral: oral hygiene instructions

non-smoker with gingivitis.

ACTIVE COMPARATOR

oral hygiene instructions

Behavioral: oral hygiene instructions

Interventions

oral hygiene instructions BEHAVIORAL

Standardized motivation and oral hygiene instructions regarding the tooth brushing will be demonstrated to all three groups using modified bass technique and a standardized brush, medium bristled brush with toothpaste, the patients will be instructed to brush their teeth for 2 minutes with a pea- size amount of dentifrice twice daily. For interdental cleaning aids each patient will be instructed to use the suitable methods regarding the space between teeth. clinically for each patient to ensure that the patients understood the instruction sessions. Before receiving oral hygiene instructions and motivation, the salivary sample will be collected and clinical periodontal parameters will be measured at a base line visit then, after 3 weeks, saliva will be collected and the same clinical measurements will be taken.

cigarette smoker with gingivitis.; electronic cigarette smoker with gingivitis.; non-smoker with gingivitis.

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• the included participant will be patients smoking cigarette at least 12 months no more than 8 cigarettes per day, patients use electronic vape in categories of low to medium dependance according to the Penn state electronic cigarette dependence index (one time consist of around 15 puffs or last around ten minutes). participants who never consumed tobacco in any form during their lifetime, having minimum of 20 teeth, additionally, all of involved patients having generalized gingivitis with intact periodontium in which they have more than 10% bleeding sites with no PPD \>3 mm with no clinical attachment loss according to criteria proposed by (Chapple in,2018).

You may not qualify if:

• dual smokers, smokeless tobacco, heavy smokers, patient using high nicotine formula (more than 25 mg/ml), periodontitis patient, patient with systemic diseases, females, participants who had used antibiotics, steroidal or non-steroid anti-inflammatory drugs within the past 6 months, patients who had undergone periodontal therapy within the last 6 months and patients unwilling to participate in study.

Sponsors & Collaborators

• University of Baghdad: lead

MeSH Terms

Conditions

Vaping; Smoking; Gingivitis

Condition Hierarchy (Ancestors)

Behavior; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Abdulrahman Khazaal, B.D.S

CONTACT

+9647830155200; abd.alaa2205@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: lab technician and statistician will be masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.D.S

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: December 20, 2023
• Primary Completion: March 20, 2024
• Study Completion: June 20, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12