None listed
Conditions
Brief summary
This clinical trial will study how smoking and nicotine exposure influence the performance of common dental local anesthetics. Healthy adult volunteers from different smoking categories, non-smokers, passive smokers, cigarette, e-cigarette, dual, and shisha users, will receive both lidocaine and articaine injections in a randomized, double-blind design. Researchers will measure how fast numbness begins, how long it lasts, and how completely it works using standardized electric and soft-tissue tests.
Interventions
All maxillary buccal infiltrations (both articaine and lidocaine visits) will be administered by one calibrated dentist to minimize operator variability.
The anesthetic will be prepared/coded according to the randomization schedule by an independent assistant, and the injecting dentist will use the coded cartridge/syringe to maintain blinding.
Intervention Visit 1: 4% articaine with 1:100,000 epinephrine, 1.8 mL maxillary buccal infiltration adjacent to the first premolar (or second premolar if
All maxillary buccal infiltrations (both articaine and lidocaine visits) will be administered by one calibrated dentist to minimize operator variability. The anesthetic will be prepared/coded according to the randomization schedule by an independent assistant, and the injecting dentist will use the coded cartridge/syringe to maintain blinding. Intervention Visit 1: 4% articaine with 1:100,000 epinephrine, 1.8 mL maxillary buccal infiltration adjacent to the first premolar (or second premolar if the first is absent). Follow-up/assessment period: 2 hours. Intervention Visit 2: 2% lidocaine with 1:100,000 epinephrine, 1.8 mL maxillary buccal infiltration at the same site in the alternate visit. Follow-up/assessment period: 2 hours. Design: Two visits per participant separated by 1 week; sequence randomized. Cartridges are coded, using identical syringes and needles; allocation is concealed. Group 1: Non-smokers (never users) Students who have never used any tobacco or nicotine product and have no regular second-hand smoke exposure, classified by self-report. Group 2: Passive smokers (second-hand smoke exposure) Non-users of tobacco/ENDS who are regularly exposed to second-hand cigarette smoke for at least 1 hour per day on at least 1 day per week, for at least 6 months. Group 3: Exclusive e-cigarette (ENDS) users Students using ENDS only (no cigarettes or shisha), daily or on some days (1–4 days/week) for at least 3 months. If former conventional smokers, all combustible products must have been stopped at least 12 months earlier. Group 4: Conventional cigarette smokers (combustible only) Current cigarette smokers (daily or some-day use for at least 3 months) with a lifetime consumption of 100 or more cigarettes. Group 5: Dual/poly users (cigarettes with ENDS and/or shisha) Students who concurrently use at least two nicotine products (e.g., cigarettes and ENDS, shisha and cigarettes, shisha and ENDS) for at least 3 months. Group 6: Exclusive shisha (waterpipe) smokers Students who smoke shisha at least 1 session per week over the past at least 6 months and do not use cigarettes or ENDS.
Sponsors
Rola Shadid (Arab American University)
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
• Students at Arab American university aged 18 to 30 years. • ASA Physical Status I (healthy individuals with no systemic disease). • Willingness to refrain from nicotine use for at least 2 hours prior to the procedure to minimize the acute pharmacologic effects of nicotine on anesthetic onset and efficacy. • No prior adverse reaction to local anesthetics. • Ability to understand the study procedures and provide written informed consent. • Maxillary first premolar or second premolar if first is not present to have no dental restorations, no gross caries, no pulp canal calcification, and a normal EPT sensitivity value (10-50 units) • Clear classification into one of the following six nicotine-use groups, confirmed through self-report and salivary cotinine biomarker analysis: • Conventional smokers • E-cigarette users • Dual users • Non-smokers • Passive smokers • Shisha smokers
Exclusion criteria
• Known or suspected allergies or sensitivities to sulfites or amide-type local anesthetics • Current pregnancy or lactation. • Current orthodontic treatment. • Oral infection, significant gingival inflammation, or mucosal ulceration at the proposed injection site. • History of neurological disorders, chronic pain syndromes, or psychiatric illness. • Prior facial or maxillofacial surgery or trauma involving the maxillary region. • High level of dental anxiety or phobia related to dental injections according to Dental Anxiety Scale. • Use of certain medications—such as nonselective beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, phenothiazines, butyrophenones, vasopressors, ergot-type oxytocics, aspirin, acetaminophen, NSAIDs, opioids, or other analgesics-within 24 hours prior to study; receipt of any investigational drug or participation in another study within the previous four weeks; and the need for sedation (oral, inhalational, or intravenous) to tolerate the injection procedure.
Outcome results
None listed