Effectiveness of Aromatherapy and Digital Anesthesia in Managing Dental Anxiety and Pain in Children

NCT07547371 | Recruiting

• 1 other identifier: 2019-KAEK-136
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to learn whether aromatherapy and digital anesthesia are effective in reducing dental anxiety and pain during tooth extraction in children. The study also aims to understand how these methods influence children's comfort and cooperation during treatment. The main questions this study aims to answer are: Do aromatherapy (lavender and orange essential oils) and digital anesthesia reduce dental anxiety and pain during tooth extraction in children? Are these methods more comfortable and less stressful for pediatric patients compared to traditional anesthesia techniques? Does digital anesthesia improve cooperation and ease of management during dental treatment? Researchers will compare aromatherapy and digital anesthesia with conventional anesthesia methods to determine whether these techniques make the extraction process easier and more comfortable for children. Participants will: Receive either aromatherapy, digital anesthesia, conventional anesthesia, or a combination depending on the study group Undergo tooth extraction under controlled clinical conditions Be evaluated before, during, and after treatment using standardized pain and anxiety scales Provide post-treatment feedback along with their parents regarding comfort and anxiety levels This study may help identify gentler and more child-friendly approaches to managing anxiety and pain during pediatric dental procedures.

Conditions

Pain; Dental Anxiety; Tooth Extraction

Keywords

Dental anxiety; Dental pain; Primary molar extraction; Aromatherapy; Computer-controlled anesthesia

Outcome Measures

Primary Outcomes (2)

• Wong-Baker FACES Pain Rating Scale (WBS)

  Pain will be assessed using the Wong-Baker FACES Pain Rating Scale (0-10). The scale consists of six facial expressions corresponding to scores of 0, 2, 4, 6, 8, and 10, where 0 indicates "no pain" and 10 indicates "worst pain possible." Children will be asked to select the face that best represents their pain intensity during local anesthesia injection. Higher scores indicate greater perceived pain.

  Immediately after local anesthesia administration ant after tooth extraction

• FLACC Scale (Face, Legs, Activity, Cry, Consolability): (behavioral assessment)

  Behavioral pain will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability; total score range 0-10). Each of the five categories is scored from 0 to 2, with a total score calculated by summing all categories. A score of 0 indicates no pain, 1-3 mild discomfort, 4-6 moderate pain, and 7-10 severe pain. Higher scores indicate greater pain-related behavioral distress during local anesthesia injection.

  During local anesthesia injection and tooth extraction

Secondary Outcomes (5)

• Facial Image Scale (FIS) for assessment of dental anxiety

  At predefined time points: before the procedure (baseline), after aromatherapy (when applicable), immediately after local anesthesia, and immediately after tooth extraction

• Heart rate during dental procedure

  At predefined time points: before the procedure (baseline), after aromatherapy (when applicable), during local anesthesia administration, immediately after anesthesia, during tooth extraction, and immediately after extraction

• Oxygen saturation (SpO₂) during dental procedure

  At predefined time points: before the procedure (baseline), after aromatherapy (when applicable), during local anesthesia administration, immediately after anesthesia, during tooth extraction, and immediately after extraction

• Systolic blood pressure during dental procedure

  At predefined time points: before the procedure (baseline), after aromatherapy (when applicable), during local anesthesia administration, immediately after anesthesia, during tooth extraction, and immediately after extraction

• Diastolic blood pressure during dental procedure

  At predefined time points: before the procedure (baseline), after aromatherapy (when applicable), during local anesthesia administration, immediately after anesthesia, during tooth extraction, and immediately after extraction

Study Arms (4)

Conventional Anesthesia

ACTIVE COMPARATOR

Infiltration anesthesia using conventional syringe prior to tooth extraction.

Drug: Traditional Local Anesthesia (Conventional Syringe)

Aromatherapy + Conventional Anesthesia

EXPERIMENTAL

Aromatherapy via inhalation (lavender + orange oil) using diffuser prior to extraction Followed by conventional anesthesia

Other: Aromatherapy (Lavender or Orange Essential Oil)

Digital Anesthesia Group (SleeperOne 5)

EXPERIMENTAL

Participants will not receive aromatherapy. Local anesthesia will be administered using the SleeperOne 5 computerized digital anesthesia system, which regulates injection pressure and flow rate through its resistance analysis technology.

Device: Digital Local Anesthesia (SleeperOne 5)

Combination Group (Aromatherapy + Digital Local Anesthesia)

EXPERIMENTAL

Participants in this group will receive both aromatherapy (lavender or orange essential oil) and digital local anesthesia delivered via the SleeperOne 5 device.

Other: Aromatherapy (Lavender or Orange Essential Oil); Device: Digital Local Anesthesia (SleeperOne 5)

Interventions

Traditional Local Anesthesia (Conventional Syringe) DRUG

Local anesthesia will be administered using a conventional dental syringe with a standard injection technique. No computerized delivery system will be used.

Also known as: Standard syringe anesthesia

Conventional Anesthesia

Aromatherapy (Lavender or Orange Essential Oil) OTHER

Participants will receive inhalational aromatherapy using lavender or orange essential oil prior to the dental procedure.

Also known as: Inhalational aromatherapy

Aromatherapy + Conventional Anesthesia; Combination Group (Aromatherapy + Digital Local Anesthesia)

Digital Local Anesthesia (SleeperOne 5) DEVICE

Local anesthesia will be administered using the SleeperOne 5 computerized anesthesia delivery device (Dentalhitec, France).

Also known as: Computer-controlled local anesthesia

Combination Group (Aromatherapy + Digital Local Anesthesia); Digital Anesthesia Group (SleeperOne 5)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants will be recruited from the Department of Pediatric Dentistry at Istanbul University Faculty of Dentistry who meet the following criteria:
• Children aged 6-12 years,
• Indicated for extraction of a mandibular primary molar without acute infection or abscess,
• No use of analgesic or sedative medications within the previous 24 hours,
• Absence of any systemic disease,
• Behavior rated as Category 2, 3, or 4 on the Frankl Behavior Rating Scale,
• Voluntary agreement to participate in the study.

You may not qualify if:

• Children with a history of systemic disease or those taking medications on a regular basis,
• Known allergy to local anesthetic agents or essential oils,
• Use of analgesic or sedative medications within the previous 24 hours,
• Children with asthma, chronic obstructive pulmonary disease (COPD), upper respiratory tract infections, or any respiratory condition that may increase sensitivity to inhalational therapies,
• Children rated as Category 1 on the Frankl Behavior Rating Scale, indicating an inability to cooperate,
• Teeth indicated for extraction due to acute infection or abscess,
• Patients with teeth presenting mobility, ankylosis, or root resorption exceeding one-third of the root length.

Sponsors & Collaborators

• Arzu Pınar Erdem: lead
• Bilimsel Araştirma Projeleri Birimi, Istanbul Üniversitesi: collaborator

Study Sites (1)

Istanbul University, Faculty of Dentistry, Department of Pediatric Dentistry

Istanbul, Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Anil O, Keskin G. Comparison of computer controlled local anesthetic delivery and traditional injection regarding disruptive behaviour, pain, anxiety and biochemical parameters: a randomized controlled trial. J Clin Pediatr Dent. 2024 Jan;48(1):120-127. doi: 10.22514/jocpd.2023.046. Epub 2024 Jan 3.

  PMID: 38239164 BACKGROUND

• Arslan I, Aydinoglu S, Karan NB. Can lavender oil inhalation help to overcome dental anxiety and pain in children? A randomized clinical trial. Eur J Pediatr. 2020 Jun;179(6):985-992. doi: 10.1007/s00431-020-03595-7. Epub 2020 Feb 6.

  PMID: 32030454 BACKGROUND

• Vitale MC, Gallo S, Pascadopoli M, Alcozer R, Ciuffreda C, Scribante A. Local anesthesia with SleeperOne S4 computerized device vs traditional syringe and perceived pain in pediatric patients: a randomized clinical trial. J Clin Pediatr Dent. 2023 Jan;47(1):82-90. doi: 10.22514/jocpd.2023.002. Epub 2023 Jan 3.

  PMID: 36627224 BACKGROUND

Related Links

• Related Info
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MeSH Terms

Conditions

Pain; Toothache

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Facial Pain

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Arzu Pınar Erdem, professor

CONTACT

+90 532 543 14 53; apinar@istanbul.edu.tr

Yonca Bircan Erçin

CONTACT

+90 543 599 04 94; ybnrcn_2000@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was performed. This is an open-label clinical trial, and neither participants nor investigators were blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned into four parallel intervention groups. Each participant will receive only one type of intervention combination, and no crossover between groups will occur. This model allows comparison of conventional anesthesia, digital anesthesia, aromatherapy support, and their combined applications during primary molar extraction in children.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 23, 2026
• Study Start: December 11, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 4, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)