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Effect of Dental Anxiety on Mandibular Anesthesia Success

K

Kutahya Health Sciences University

Status

Completed

Conditions

Symptomatic Irreversible Pulpitis
Dental Anxiety

Treatments

Procedure: Standardized Mandibular Anesthesia Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT07124273
KutahyaHSU-3

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Low Anxiety Group
Experimental group
Description:
Participants with Modified Dental Anxiety Scale (MDAS) scores less than 10.
Treatment:
Procedure: Standardized Mandibular Anesthesia Protocol
Moderate-High Anxiety Group
Experimental group
Description:
Participants with MDAS scores of 11 or higher, including those with dental phobia (MDAS \> 19).
Treatment:
Procedure: Standardized Mandibular Anesthesia Protocol

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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