Clinical trial NCT06852066: Comparison of Computer-Assisted and Conventional Local Anesthesia Methods in Impacted Wisdom Tooth Surgery
Official title: Comparison of the Effects of Computer-Assisted Local Anesthesia and Conventional Local Anesthesia on Anxiety, Pain and Operation During Impacted Wisdom Tooth Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Molar, Third
Surgery, Oral
Anxiety
Local Anesthesia
Hemodynamic Changes
Comparison of the Efficacy
Computer Assisted Local Anesthesia
Keywords: Ccomputer assisted local anesthesia
Conventional local anesthesia
Wisdom tooth
Surgery
Anxiety
Hemodynamic changes
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 1. Computer-Assisted Local Anesthesia Group (Arm 1)

   Participants in this group will receive computer-assisted local anesthesia using the SleeperOne5 (Dental Hi Tec, Cholet, France) system. The anesthetic used will be 2% articaine with 1:100,000 epinephrine. Injection will be performed under controlled pressure, with an administration duration of 60 seconds.

   Inferior alveolar nerve block and supplemental buccal anesthesia will be applied.
2. Conventional Local Anesthesia Group (Arm 2)

Participants in this group will receive conventional local anesthesia using a standard dental syringe (40 mm 27G needle) under manual pressure. The anesthetic used will be 2% articaine with 1:100,000 epinephrine. The injection duration will be 30 seconds under manual pressure. Inferior alveolar nerve block and supplemental buccal anesthesia will be applied.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effects of computer-assisted local anesthesia and conventional local anesthesia on pain perception and dental anxiety during inferior alveolar block anesthesia in impacted mandibular third molar surgeries with bone retention. The study also aims to assess the impact of anesthesia techniques on physiological parameters during the procedure.

The main questions it aims to answer are:

Does computer-assisted local anesthesia reduce pain perception compared to conventional local anesthesia? What are the effects of both anesthesia techniques on dental anxiety and vital signs (systolic/diastolic blood pressure, pulse rate, oxygen saturation, and respiratory rate) during the procedure?

Participants who meet the inclusion criteria will undergo impacted mandibular third molar extractions under two different anesthesia techniques:

One group will receive computer-assisted local anesthesia. The other group will receive conventional local anesthesia. Anxiety and pain measurements will be recorded during the anesthesia administration and throughout the surgical procedure. Vital signs, including systolic and diastolic blood pressure, pulse rate, oxygen saturation, and respiratory rate, will be monitored and compared between the study groups.

This study aims to provide insights into improving pain management and patient comfort during oral surgical procedures.

Detailed description: This clinical trial aims to compare the effects of computer-assisted local anesthesia and conventional local anesthesia on pain perception, dental anxiety, and physiological responses during inferior alveolar nerve block in impacted mandibular third molar surgeries with bone retention. The study evaluates whether the computer-assisted anesthesia technique provides better pain control and reduces anxiety compared to the conventional technique.

Study Design This is a randomized, single-blind clinical trial involving 40 participants who meet the inclusion criteria. Each participant will undergo bilateral, symmetrical impacted mandibular third molar extractions. One side will be anesthetized using computer-assisted local anesthesia, while the other side will receive conventional local anesthesia. A researcher uninvolved in the surgeries will conduct the randomization, using sequentially numbered envelopes to determine the technique and the side to be operated on first. Participants will be blinded to the anesthesia technique used during the procedure.

Anesthesia Protocol Inferior alveolar nerve block and supplemental buccal anesthesia will be applied in both study groups.

Conventional Local Anesthesia: Administered with a 40 mm 27G dental syringe under manual pressure.

Computer-Assisted Local Anesthesia: Performed using the SleeperOne5 (Dental Hi Tec, Cholet, France) system with a 35 mm 30G syringe under controlled pressure.

The anesthetic solution in both groups will be 2% articaine with 1:100,000 epinephrine. The maximum amount administered will be 2 cartridges for the computer-assisted group and 2 ampoules for the conventional group per session. Injection speed is fixed at 60 seconds for the computer-assisted group, while in the conventional group, it will be administered in 30 seconds. The inferior alveolar nerve block will be performed by a single surgeon for all patients to ensure standardization.

Surgical Procedure

A standardized impacted third molar extraction procedure will be performed for all participants. The steps are as follows:

Incision and Flap Elevation: A No. 15 scalpel blade will be used to create an envelope flap incision in the mucosa. The flap will be elevated with a periosteal elevator.

Bone Removal: Access to the impacted tooth will be achieved through bone removal using a surgical micromotor (NsK model, 40,000 rpm) with a steel round or fissure bur under continuous sterile saline irrigation.

Tooth Extraction: Following osteotomy and tooth sectioning (if needed), the impacted tooth will be extracted.

Wound Closure: The flap will be repositioned and sutured using 3/0 atraumatic silk sutures (16 mm, 3/8 round needle).

The surgical protocol will be identical in both groups, ensuring no variability in the procedure itself.

Pain and Anxiety Assessment

Multiple validated scales will be used to assess pain, anxiety, and patient perception of the procedure at different time points:

Before and after anesthesia administration:

Dental Anxiety Scale State-Trait Anxiety Inventory (STAI) Modified Dental Anxiety Scale (MDAS) Amsterdam Preoperative Anxiety Scale (APAIS) Dental Fear Scale (DKS) Visual Analog Scale (VAS)

Immediately after the surgery:

Postoperative versions of the above scales Postoperative satisfaction questionnaire Physiological Measurements

During the study, vital signs will be monitored at predefined time intervals:

Systolic and diastolic blood pressure Pulse rate Oxygen saturation Respiratory rate

These parameters will be recorded at the following time points:

Before anesthesia administration During local anesthesia injection During each step of the surgery (incision, osteotomy, extraction, suturing) After the procedure Postoperative Care

All patients will be prescribed a standard postoperative regimen, including:

Antibiotics (Penicillin or Clindamycin) NSAID pain relievers (Naproxen sodium) Chlorhexidine gluconate mouthwash Instructions for a soft diet and maintaining oral hygiene Statistical Analysis Sample size was determined using G\*Power 3.1.9.4 software. Based on an effect size of 0.35, Type I error of 0.05, and statistical power of 80%, the required sample size was calculated as 35 participants. To account for potential exclusions, 40 participants will be included.

Eligibility criteria: Inclusion Criteria:

Participants must meet all of the following criteria to be included in the study:

* Must be between 18 and 40 years old
* Must have bilaterally impacted mandibular third molars with bone retention
* Impacted teeth must be at a mesioangular angle, classified as Class 1-2 and A--B type (Pell \& Gregory classification)
* Must have an impacted tooth difficulty level of 3-5 according to the Pederson Difficulty Index
* Must be classified as ASA 1 (healthy individuals with no systemic diseases)
* Must be able to read and understand questionnaire forms and provide informed consent Must voluntarily agree to participate in the study and sign the informed consent form

Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

* Presence of any systemic disease (e.g., cardiovascular disease, liver disease, hematologic disorders, neoplastic diseases, rheumatic conditions, diabetes mellitus)
* History of psychiatric disorders or current use of anxiolytics, antidepressants, or anticonvulsants
* Use of anti-inflammatory, analgesic, or anxiolytic medications prior to the procedure that could affect pain, inflammation, or anxiety responses
* Chronic medication use, including antihistamines, NSAIDs, steroids, or antidepressants
* Presence of oral pathologies affecting pain perception (e.g., pulpitis, periodontitis, oral ulcers, cysts, or tumors)
* Suspected or confirmed pregnancy or breastfeeding
* Allergy to the local anesthetic (articaine) used in the study
* Hearing impairment that could interfere with study participation
* Presence of dentophobia (severe dental phobia)

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: During surgery, at the following time points: Immediately after local anesthesia injection, Immediately after surgery
measure: Modified Dental Anxiety Scale (MDAS) Score
timeFrame: Before local anesthesia injection (Baseline), Immediately after surgery
measure: Dental Fear Scale (DKS) Score
timeFrame: Before local anesthesia injection (Baseline), Immediately after surgery
measure: State-Trait Anxiety Inventory (STAI) Score
timeFrame: Before local anesthesia injection (Baseline), Immediately after surgery
measure: Amsterdam Preoperative Anxiety Scale (APAIS) Score
timeFrame: Before local anesthesia injection (Baseline), Immediately after surgery
Secondary outcomes:
measure: Systolic and Diastolic Blood Pressure Changes
timeFrame: Before local anesthesia injection (Baseline) Immediately after local anesthesia injection During surgery at key procedural steps (incision, osteotomy, extraction) Immediately after surgery
measure: Pulse Rate Changes
timeFrame: Before local anesthesia injection (Baseline) Immediately after local anesthesia injection During surgery at key procedural steps (incision, osteotomy, extraction) Immediately after surgery
measure: Oxygen Saturation Levels (SpO₂) During Surgery
timeFrame: Before local anesthesia injection (Baseline) Immediately after local anesthesia injection During surgery at key procedural steps (incision, osteotomy, extraction) Immediately after surgery
measure: Respiratory Rate Changes
timeFrame: Before local anesthesia injection (Baseline) Immediately after local anesthesia injection During surgery at key procedural steps (incision, osteotomy, extraction) Immediately after surgery
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences University, Faculty of Dentistry
Study officials:
References:
citation: Ozer S, Yaltirik M, Kirli I, Yargic I. A comparative evaluation of pain and anxiety levels in 2 different anesthesia techniques: locoregional anesthesia using conventional syringe versus intraosseous anesthesia using a computer-controlled system (Quicksleeper). Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Nov;114(5 Suppl):S132-9. doi: 10.1016/j.oooo.2011.09.021. Epub 2012 May 6.
citation: Libonati A, Nardi R, Gallusi G, Angotti V, Caruso S, Coniglione F, Marzo G, Mattei A, Tecco S, Paglia L. Pain and anxiety associated with Computer-Controlled Local Anaesthesia: systematic review and meta-analysis of cross-over studies. Eur J Paediatr Dent. 2018 Dec;19(4):324-332. doi: 10.23804/ejpd.2018.19.04.14.
citation: Araujo GM, Barbalho JC, Dias TG, Santos Tde S, Vasconcellos RJ, de Morais HH. Comparative Analysis Between Computed and Conventional Inferior Alveolar Nerve Block Techniques. J Craniofac Surg. 2015 Nov;26(8):e733-6. doi: 10.1097/SCS.0000000000002245.