Effect of Dental Anxiety on Mandibular Anesthesia Success

NCT07124273 — Not applicable, Completed, 52 participants, Kutahya Health Sciences University

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

Registry	NCT07124273
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, basic science
Enrollment	52 (Actual)
Sponsor	Kutahya Health Sciences University (Other)
Conditions	Dental Anxiety, Symptomatic Irreversible Pulpitis
Interventions	Standardized Mandibular Anesthesia Protocol (Procedure)
Dates	start 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 in Turkey (Türkiye)

-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.

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+Arms and interventions

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

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.

+Outcome measures

Primary outcomes

Success Rate of Mandibular Anesthesia [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

Correlation Between Dental Anxiety Level and Anesthesia Success [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.
Salivary Cortisol Level Change [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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Kutahya Health Sciences University Faculty of Dentistry	Kütahya	Turkey (Türkiye)

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2024-12-15)

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