Effect of Dental Anxiety on Mandibular Anesthesia Success

NCT07124273 | Completed

• 1 other identifier: KutahyaHSU-3
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dental Anxiety; Local Anesthesia Failure; Salivary Cortisol; Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Success Rate of Mandibular Anesthesia

  The success of inferior alveolar nerve block (IANB) will be determined based on the patient's pain response during endodontic treatment, measured using the Heft-Parker Visual Analog Scale (HP-VAS). Anesthesia will be considered successful if pain during treatment is rated as "none" or "mild" on HP-VAS.

  Within 30 minutes after anesthesia administration, during the endodontic procedure

Secondary Outcomes (2)

• Correlation Between Dental Anxiety Level and Anesthesia Success

  At the end of the single treatment session (within 30 minutes after anesthesia administration)

• Salivary Cortisol Level Change

  Pre-anesthesia and 15 minutes post-anesthesia

Study Arms (2)

Low Anxiety Group

EXPERIMENTAL

Participants with Modified Dental Anxiety Scale (MDAS) scores less than 10.

Procedure: Standardized Mandibular Anesthesia Protocol

Moderate-High Anxiety Group

EXPERIMENTAL

Participants with MDAS scores of 11 or higher, including those with dental phobia (MDAS \> 19).

Procedure: Standardized Mandibular Anesthesia Protocol

Interventions

Standardized Mandibular Anesthesia Protocol PROCEDURE

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.

Low Anxiety Group; Moderate-High Anxiety Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University Faculty of Dentistry

Kütahya, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 15, 2025
• Study Start: December 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: December 15, 2024
• Last Updated: August 15, 2025

Record last verified: 2025-07

Locations

TU (1)