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NCT Number: NCT07124273

Effect of Dental Anxiety on Mandibular Anesthesia Success

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.

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Key information

Conditions

Dental Anxiety Symptomatic Irreversible Pulpitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University Faculty of Dentistry

Kütahya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Success Rate of Mandibular Anesthesia

    Time frame: Within 30 minutes after anesthesia administration, during the endodontic procedure

    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.

Secondary outcomes

  1. Correlation Between Dental Anxiety Level and Anesthesia Success

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

    Relationship between Modified Dental Anxiety Scale (MDAS; score range 5-25, higher scores indicate greater anxiety) and anesthesia success rates during a single endodontic treatment session.

  2. Salivary Cortisol Level Change

    Time frame: Pre-anesthesia and 15 minutes post-anesthesia

    Difference in salivary cortisol levels measured 15 minutes before and 15 minutes after anesthesia to assess stress response related to dental anxiety.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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