Effect of Dental Anxiety on Mandibular Anesthesia Success (NCT07124273) | Clinical Trial Compass
CompletedNot Applicable
Effect of Dental Anxiety on Mandibular Anesthesia Success
Turkey (Türkiye)52 participantsStarted 2023-12-15
Plain-language summary
The goal of this clinical trial is to evaluate the effect of dental anxiety on the success of mandibular anesthesia in patients with symptomatic irreversible pulpitis in mandibular molar teeth.
The main questions it aims to answer are:
Does dental anxiety influence the success rate of inferior alveolar nerve block (IANB)? Is there a correlation between salivary cortisol levels and anesthesia outcomes in anxious patients?
Researchers will compare two groups of patients based on their Modified Dental Anxiety Scale (MDAS) scores:
Low/No anxiety group (MDAS \< 10) Moderate to high anxiety group (MDAS ≥ 11, including those with dental phobia)
Participants will:
Rate their pre-treatment pain using the Heft-Parker Visual Analog Scale (HP-VAS) Provide salivary samples for cortisol measurement before and after anesthesia Undergo standardized mandibular anesthesia protocols (IANB and buccal-lingual infiltration) Report pain during treatment using the HP-VAS Undergo monitoring of SpO₂ and pulse via pulse oximetry To control for cortisol fluctuations and circadian rhythm, all procedures and saliva collections will occur between 09:00-12:00. Participants will be asked to avoid food for at least 2 hours prior, and refrain from caffeine, alcohol, smoking, or heavy exercise for at least 24 hours before treatment.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged between 18 and 65 years
* Systemically healthy individuals who agree to participate in the study
* Mandibular molar teeth diagnosed with symptomatic irreversible pulpitis requiring root canal treatment
* Teeth with closed apex and no periapical lesions visible radiographically
* Periodontally healthy teeth according to Glickman's criteria, with probing depth ≤ 3 mm
* Teeth with mobility less than 0.5 mm
* Patients experiencing moderate (55-113 mm) or severe pain (114-170 mm) according to the Heft-Parker Visual Analog Scale (HP-VAS)
Exclusion Criteria:
* Patients with any systemic disease
* Teeth with open apex or radiographic evidence of periapical pathology
* Teeth showing internal or external root resorption
* Teeth that do not meet Glickman's periodontal health criteria or have probing depth \> 3 mm
* Teeth with mobility greater than 0.5 mm
* Patients experiencing no pain (0 mm) or mild pain (1-54 mm) on the HP-VAS
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Success Rate of Mandibular Anesthesia
Timeframe: Within 30 minutes after anesthesia administration, during the endodontic procedure