The Effect of Dental Anxiety on the Success of Mandibular Anesthesia in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis: A Prospective Clinical Study
Phase: NA
Conditions: Dental Anxiety, Symptomatic Irreversible Pulpitis
Sponsor: Kutahya Health Sciences University

Off#c#al T#tle: The Effect of Dental Anxiety on the Success of Mandibular Anesthesia in 
Mandibular Molar Teeth with Symptomatic Irreversible Pulpitis: A Prospective Clinical Study 
NCT Number: Not available 
Date: 15/12/2024  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Null Hypothesis (H₀): Dental anxiety does not affect the success of mandibular anesthesia in the 
treatment of symptomatic irreversible pulpitis in mandibular molar teeth. 
Study arms: A prospective clinical trial with two parallel intervention arms. Participants will be divided 
into two groups based on their Modified Dental Anxiety Scale (MDAS) scores: 
• 
Group 1 (Low Anxiety Group): MDAS score < 10 
• 
Group 2 (Moderate to High Anxiety Group): MDAS score ≥ 11 (including those with dental 
phobia if MDAS > 19) 
Sample Size Calculation: Using G*Power 3.1.9.7 software, based on an effect size of 0.8, α = 0.05, 
and power = 0.80, the required sample size was determined as 26 patients per group, totaling 52 
participants. The actual power achieved was 81%. 
Materials and Methods: 
Inclusion Criteria: 
o 
Systemically healthy adults aged 18–65 
o 
Mandibular molar teeth with symptomatic irreversible pulpitis requiring root canal 
treatment 
o 
Radiographic evidence of closed apex and absence of periapical pathology 
o 
Periodontal probing depth ≤ 3 mm 
o 
Tooth mobility < 0.5 mm 
o 
Pain score of 55–170 mm on the Heft-Parker Visual Analog Scale (HP-VAS) (i.e., 
moderate or severe pain) 
o 
 
• 
Exclusion Criteria: 
o 
Systemic disease 
o 
Teeth with open apex, periapical lesion, internal or external resorption 
o 
Periodontal probing depth > 3 mm 
o 
Tooth mobility > 0.5 mm 
o 
HP-VAS score < 55 mm (no or mild pain) 
o 
Pregnant patients or those with allergy to articaine 
 

Procedure: 
• 
All treatments and measurements will be conducted between 09:00 and 12:00 to minimize 
circadian and cortisol fluctuations. 
• 
Patients will avoid food intake for at least 2 hours before treatment and abstain from caffeine, 
alcohol, tobacco, and intense exercise within 24 hours. 
• 
Patients will rest in the dental chair for 5 minutes, then their demographic data will be recorded. 
• 
MDAS will be administered to assess anxiety level. 
• 
HP-VAS will be used to assess pre-treatment pain level. 
• 
Pulse rate, SpO₂, and salivary cortisol levels will be recorded pre- and post-anesthesia. 
Anesthesia Protocol: 
• 
All procedures are performed by a single operator in a one-unit room. 
• 
Topical anesthesia: 10% lidocaine spray (Locanest) applied for 60 seconds. 
• 
IANB (Inferior Alveolar Nerve Block): 
o 
1.8 ml of 4% articaine hydrochloride with 1:100,000 epinephrine (Ultracaine DS Forte) 
via 27G needle 
• 
Buccal and lingual infiltration: 
o 
Additional 1.8 ml injection performed 5 minutes after IANB 
• 
Block Failure Definition: 
o 
If deep lip numbness is not achieved within 15 minutes, the block is considered failed 
and the participant is withdrawn from the study. 
Outcome Evaluation: 
• 
During treatment, if the patient feels pain, they raise their hand, and the pain is marked on the 
HP-VAS. 
• 
If required, supplemental anesthesia (PDL or intrapulpal) will be administered and recorded. 
• 
Successful anesthesia: No or mild discomfort 
• 
Failed anesthesia: Moderate or severe pain 
• 
Cold test will be performed 15 minutes after IANB. If positive, additional anesthesia will be 
given. 
 Biological Sampling: 
• 
Saliva samples will be collected 15 minutes before and after anesthesia. 
• 
Samples will be stored at -80°C until analysis. 
• 
Special sterile, single-use Sali-Tubes (SLV-4158, DRG, Germany) will be used. 

Statistical Analysis: 
All statistical analyses will be performed using SPSS Statistics 20 software (IBM Corp., Armonk, NY) 
at a 5% significance level. If the data are normally distributed, Student’s t-test will be used to compare 
preoperative pain levels, salivary cortisol, SpO₂, and pulse rate across different anxiety levels. Chi-
square test will be used to analyze the relationship between anxiety levels and the success rate of 
anesthesia.