NCT07124273

Effect of Dental Anxiety on Mandibular Anesthesia Success

The Effect of Dental Anxiety on the Success of Mandibular Anesthesia in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis: A Prospective Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Kutahya Health Sciences University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dental Anxiety
• Symptomatic Irreversible Pulpitis

Interventions

Type	Name	Description
PROCEDURE	Standardized Mandibular Anesthesia Protocol	Participants receive an inferior alveolar nerve block (IANB) using 1.8 ml 4% articaine with 1:100,000 epinephrine (Ultracaine DS Forte) via a 27-gauge dental needle, followed by buccal and lingual infiltration anesthesia after 5 minutes. Topical 10% lidocaine spray is applied prior to injection. All procedures are performed by the same clinician between 09:00-12:00. Salivary cortisol, pulse oximetry, and pain assessments are conducted before and after the anesthesia.

Timeline

• Start date: 2023-12-15
• Primary completion: 2024-06-15
• Completion: 2024-12-15
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

1 site across 1 country: Turkey (Türkiye)