Assessing the Effectiveness of Aromatherapy and Digital Anesthesia Techniques for the Management of Tooth-Extraction-Related Dental Anxiety and Pain in Children
Phase: NA
Conditions: Pain, Dental Anxiety, Tooth Extraction
Sponsor: Arzu Pınar Erdem

 
 
 
 
 
STUDY PROTOCOL 
 
 
 
DOCUMENT DATE: 08 December 2025 
 
NCT : Not yet assigned 
 
 
 
 
 
 
 
 
 
 
 
 
 

Title: EVALUATION OF AROMATHERAPY AND COMPUTER-CONTROLLED 
LOCAL ANESTHETIC DELIVERY SYSTEMS ON DENTAL ANXIETY AND PAIN 
IN CHILDREN UNDERGOING TOOTH EXTRACTION 
Sponsor 
Istanbul University Scientific Research Projects Unit (BAP) 
Background  
Dental anxiety is a highly prevalent condition among children, characterized by 
excessive fear, physiological hyperarousal, and behavioral resistance during dental 
procedures. Reports indicate that 5–40% of children experience dental anxiety, which 
negatively impacts treatment compliance and increases perceived pain. Local anesthesia 
administration and tooth extraction are among the procedures most commonly associated 
with anxiety and discomfort in pediatric patients. 
Non-pharmacological approaches such as aromatherapy have recently gained 
popularity as adjunctive methods to reduce preoperative dental anxiety. Lavender and 
sweet orange essential oils, in particular, demonstrate anxiolytic, sedative and mild 
analgesic properties. These oils exert their effects through modulation of neurotransmitters 
such as serotonin, dopamine and GABA, and have been shown to reduce heart rate, blood 
pressure, and behavioral manifestations of anxiety in children. 
Computer-controlled local anesthetic delivery (CCLAD) systems, including 
SleeperOne®, provide a controlled injection rate and pressure, reducing discomfort caused 
by sudden tissue distension during traditional injections. CCLAD-assisted intraosseous 
anesthesia has been demonstrated to produce rapid, profound pulpal anesthesia with 
minimal soft-tissue numbness, reducing postoperative complications such as lip or cheek 
biting in young children. 
Although numerous studies have evaluated aromatherapy and CCLAD separately, no study 
to date has examined the combined effect of aromatherapy and digital anesthesia on both 
dental anxiety and pain perception during tooth extraction in children. The current study 
aims to fill this gap. 

Objectives 
Primary Objective 
To evaluate the effectiveness of aromatherapy and computer-controlled local anesthetic 
delivery (SleeperOne®) in reducing dental anxiety and pain among children undergoing 
mandibular primary molar extraction. 
Secondary Objectives 
 To compare pain levels during local anesthesia administration and tooth extraction 
using traditional versus digital anesthesia techniques. 
 To assess changes in physiological parameters (heart rate, systolic and diastolic 
blood pressure, oxygen saturation) in relation to anxiety-reducing interventions. 
 To determine whether aromatherapy enhances patient cooperation and reduces 
behavioral distress during dental procedures. 
Study Design 
This is a single-center, randomized controlled clinical trial conducted in the Department of 
Pediatric Dentistry at İstanbul University, Faculty of Dentistry. Children aged 6–12 
requiring mandibular primary molar extraction will be recruited according to 
predetermined inclusion/exclusion criteria. 
Participants will be randomly assigned to one of four groups: 
Group 1: Conventional Local Anesthesia 
In this group, local anesthesia will be administered using a standard dental syringe with the 
conventional infiltration technique. Before injection, 10% lidocaine topical anesthetic will 
be applied to the dried mucosa for approximately 1–2 minutes to reduce needle‐related 
discomfort. Following topical anesthesia, the clinician will deliver infiltration anesthesia 
at a controlled pace to minimize tissue pressure and patient discomfort. 

All injections will be performed using Ultracain DS Forte (4% articaine with 1:200,000 
epinephrine), a commonly used and well-established local anesthetic agent in pediatric 
dentistry. After administration, a waiting period of approximately five minutes will allow 
adequate anesthetic diffusion before tooth extraction begins. 
Group 2: Computer-Controlled Local Anesthetic Delivery System (CCLAD) 
In this group, anesthesia will be performed using the SleeperOne® computerized 
intraosseous anesthesia device, which regulates injection speed and pressure automatically. 
This system enables precise delivery of the anesthetic solution and aims to reduce 
discomfort by maintaining a constant, controlled flow rate throughout the procedure. 
The device features a lightweight handpiece that allows pen-style grip for enhanced 
stability, improving clinician control and potentially lowering anxiety related to needle 
visibility. The intraosseous technique involves an initial mucosal anesthesia phase 
followed by controlled penetration through the cortical plate into the cancellous bone, 
enabling rapid onset pulpal anesthesia without extensive soft-tissue numbness. 
This approach represents an advanced alternative to traditional syringe injections and is 
evaluated for its potential to improve patient comfort, reduce perceived pain, and enhance 
cooperation during pediatric dental procedures. 
Group 3: Aromatherapy + Conventional Local Anesthesia 
In this group, children will receive aromatherapy prior to anesthesia. Lavender and sweet 
orange essential oils will be administered using a diffuser placed in the clinical 
environment, allowing gentle ambient inhalation without direct topical or oral exposure. 
This calming sensory intervention is designed to help reduce pre-procedural anxiety. 
Following aromatherapy, local anesthesia will be administered using the conventional 
syringe-based infiltration method. The procedure will follow the same steps described for 
Group 1, including topical anesthetic application and slow deposition of anesthetic 
solution. This group allows evaluation of whether aromatherapy enhances patient comfort 
when paired with a standard anesthetic technique. 

Group 4: Aromatherapy + Computer-Controlled Local Anesthetic Delivery System 
(CCLAD) 
In this group, aromatherapy with lavender and sweet orange essential oils will similarly be 
delivered via diffuser prior to the anesthetic procedure. After the aromatherapy exposure, 
local anesthesia will be administered using the computer-controlled SleeperOne® system, 
following the same intraosseous protocol described for Group 2. This combination aims to 
explore whether the anxiolytic benefits of aromatherapy complement the reduced-pain 
profile of digital anesthesia, potentially providing the most comfortable overall experience 
for pediatric patients undergoing tooth extraction. 
Study Population 
Inclusion Criteria 
 
Children aged 6–12 years 
 
Indicated for extraction of mandibular primary molars (without acute infection) 
 
No systemic disease 
 
Frankl Behavioral Rating Scale: Categories 2,3,4 
 
No analgesic or sedative intake within 24 hours 
 
Voluntary participation with parental informed consent 
Exclusion Criteria 
 
Allergy to articaine, epinephrine, or essential oils 
 
Asthma, respiratory disorders, or upper respiratory infections 
 
Frankl Category 1 behavior 
 
Teeth with mobility, ankylosis, or advanced root resorption 
 
Inability to comply with aromatherapy inhalation 
 

Aromatherapy Procedure 
Aromatherapy with lavender and sweet orange essential oils will be administered via an 
electric diffuser in the clinical environment prior to anesthesia. Only inhalation exposure 
will be provided; no topical or oral application will be used. 
Local Anesthesia Procedure 
Before all anesthesia applications, topical anesthesia (10% lidocaine) will be applied to the 
dried mucosa for 1–2 minutes. 
 
Groups 1 & 3: Conventional infiltration anesthesia 
 
Groups 2 & 4: Computer-controlled digital intraosseous anesthesia (SleeperOne®) 
Ultracain® DS Forte (4% articaine, epinephrine 1:200,000) will be used as the anesthetic 
agent in all groups. 
Tooth extraction will be performed after verifying adequate anesthesia. 
Outcome Measures 
1. Anxiety Assessment 
a. Physiological measurements: 
 
Systolic blood pressure 
 
Diastolic blood pressure 
 
Heart rate 
 
Oxygen saturation (SpO₂) 
Measurements will be obtained using an blood pressure monitor and pulse oximeter at the 
following timepoints: 
 
Before intervention 
 
After aromatherapy (if applicable) 

 
After anesthesia 
 
After extraction 
b. Facial Image Scale (FIS): Children will select a facial expression representing their 
emotional state at each timepoint. 
2. Pain Assessment 
a. Wong-Baker Faces Pain Rating Scale (WBS): Used to assess self-reported pain after 
anesthesia and after extraction. 
b. FLACC Scale (Face, Legs, Activity, Cry, Consolability): Used by the clinician to 
evaluate behavioral pain responses after anesthesia and extraction. 
Risks and Mitigation Strategies 
Potential Risks 
-Anxiety related to dental procedures: Children may experience procedural anxiety 
associated with local anesthesia administration or tooth extraction. 
-Mild irritation or hypersensitivity to essential oils: Although rare, inhalation of lavender 
or sweet orange oils may trigger mild allergic reactions or respiratory discomfort in 
sensitive individuals. 
-Pain or discomfort during or after extraction: Despite appropriate anesthesia, some 
children may report procedural discomfort. 
-Physiological changes during vital sign assessment: Blood pressure or pulse 
measurements performed with blood pressure monitor and pulse oximeter may cause 
temporary unease in some children. 
-Post-extraction soft-tissue injury: Accidental lip, cheek, or tongue biting may occur 
following local anesthesia. 

Risk Mitigation Measures 
-Implementation of behavior guidance techniques: Age-appropriate communication and 
behavioral support will be used to enhance cooperation and reduce anxiety. 
-Comprehensive medical and allergy screening: A detailed medical history will be taken 
before treatment to identify potential allergies or contraindications related to anesthetic 
agents or essential oils. 
-Atraumatic and standardized clinical procedures: All extractions will be performed under 
sterile conditions using minimally invasive, tissue-preserving techniques. 
-Use of validated assessment tools: Anxiety and pain will be evaluated using validated 
pediatric scales to ensure reliable measurement. 
 
Ethical Considerations 
The study will follow the Declaration of Helsinki and Good Clinical Practice. 
Parental informed consent will be obtained. 
Participation is voluntary, and withdrawal is allowed at any time.