Pain and Anxiety in Pediatric Dentistry: Computer-Controlled vs. Traditional Anesthesia

NCT07156487 | Not Yet Recruiting

• 1 other identifier: HRÜ/25.06.54
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate how different local anesthesia techniques affect pain and anxiety levels in children undergoing dental treatment. Specifically, the study compares traditional syringe-based anesthesia with a computer-controlled local anesthesia system. The study seeks to answer the following question: Which combination of anesthesia technique is most effective in reducing pain and anxiety in pediatric dental patients? By understanding the impact of these variables, the study aims to help dental professionals choose the most appropriate anesthesia approach to improve the comfort and emotional well-being of children during dental procedures.

Conditions

Traditional Local Anesthesia; Computer-controlled Electronic Anesthesia; Dental Anxiety; Anxiety in Children

Keywords

Pediatric Dentistry; Injections, Intraosseous; Dental Instruments

Outcome Measures

Primary Outcomes (8)

• To assess the patient's pain level (Before and after anesthesia)

  Wong-Baker Faces Pain Rating Scale The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst".

  through study completion, an average of 6 month.

• To assess the patient's pain level (During anesthesia)

  The Visual Analog Scale (VAS) is a unidimensional tool used to measure pain intensity on a continuous spectrum, ranging from "no pain" to "worst imaginable pain." It consists of a 10 cm line with descriptive anchors at both ends. In our study, VAS will be applied as a 10 cm horizontal line marked at 1 cm intervals to quantify pain levels.

  through study completion, an average of 6 month.

• To assess the patient's pain level (During anesthesia)

  Behavioral responses were recorded using the FLACC scale, which evaluates Face, Legs, Activity, Cry, and Consolability. Each domain is scored from 0-2, for a total range of 0-10.

  through study completion, an average of 6 month.

• To assess the patient's anxiety level (Before anesthesia )

  The CFSS-DS is a validated psychometric scale developed in 1982 to assess dental anxiety in children. It includes items scored from 1 (not afraid) to 5 (very afraid). Total scores indicate anxiety levels as follows: \<38: No anxiety 38-45: Moderate dental anxiety \>45: Severe dental anxiety

  through study completion, an average of 6 month.

• To assess the patient's anxiety level (Before and after anesthesia)

  Facial Image Scale (FIS) The Facial Image Scale (FIS) is a projective tool designed to quickly assess pre-procedural anxiety levels in young children, starting from age 3. It consists of five faces, ranging from very happy (score = 1) to very unhappy (score = 5), reflecting increasing levels of fear.

  through study completion, an average of 6 month.

• Pulse rate measurement to assess patient's dental anxiety (Before,after and during anesthesia)

  Measurement will be made with a pulse oximeter.The measurement will be performed using a pulse oximeter attached to the patient's fingertip.

  through study completion, an average of 6 month.

• Blood oxygen saturation measurement to assess patient's dental anxiety (Before,after and during anesthesia)

  Measurement will be made with a pulse oximeter.The measurement will be performed using a pulse oximeter attached to the patient's fingertip.

  through study completion, an average of 6 month.

• Body temperature measurement to assess the patient's anxiety (Before,after and during anesthesia)

  Tympanic Temperature Measurement Under stress or anxiety, adrenaline increases heart rate and body temperature. Tympanic thermometers measure core temperature through the tympanic membrane, providing accurate, non-invasive, and rapid readings. This method is effective in ICU settings for both adults and children, offering advantages like minimal infection risk and resistance to environmental changes.

  through study completion, an average of 6 month.

Secondary Outcomes (3)

• Pulse rate measurement to assess opetator's anxiety (Before,after and during anesthesia)

  through study completion, an average of 6 month.

• Body temperature measurement to assess the operator's anxiety (Before,after and during anesthesia)

  through study completion, an average of 6 month.

• Blood oxygen saturation measurement to assess operator's anxiety (Before,after and during anesthesia)

  through study completion, an average of 6 month.

Study Arms (2)

Digital Dental Anesthesia (CCLAD - Computer Controlled Local Anesthetic Delivery)

EXPERIMENTAL

For Maxillary Teeth: For maxillary teeth, the SleeperOne® 5 electronic local anesthesia system was used. After confirming pulp vitality through a cold or electric pulp test, the target area was dried, and 10% lidocaine topical anesthetic was applied for 1 minute using a cotton pellet. Then, 1.7 ml of Ultracaine D-S Fort was delivered via intraosseous injection using a 30-gauge, 9 mm Effitec needle in pediatric mode. For Mandibular Teeth: For mandibular teeth, the SleeperOne® 5 electronic local anesthesia system was used to perform intraosseous injection in pediatric mode. Prior to the injection, pulp vitality was assessed using a cold or electric pulp test. The injection site was then dried, and 10% lidocaine topical anesthetic spray was applied with a cotton pellet for 1 minute. Following this, 1.7 ml of Ultracaine D-S Fort was administered using a 30-gauge, 9 mm Effitec needle.

Device: Digital Anesthesia with SleeperOne 5

Traditional Local anesthesia Techniques

ACTIVE COMPARATOR

For the contralateral maxillary teeth: After confirming vitality, the site is dried and 10% lidocaine spray is applied for 1 minute. Buccal infiltration is performed. The cheek and lip are retracted, mucosa tightened, and the needle inserted at the tooth apex. After bone contact, the needle is withdrawn 1 mm, aspirated, and Ultracaine D-S Fort injected slowly over 1 minute using a 30G, 16 mm Effitec needle and metal carpule syringe. For the contralateral mandibular teeth: The retromolar area is dried, and 10% lidocaine spray is applied with a cotton pellet for 1 minute. After retracting the cheek and lip, the needle is inserted between the pterygomandibular raphe and internal oblique ridge, aligned with the contralateral molars. After bone contact, aspiration is performed. Ultracaine D-S Fort is slowly injected over 1 minute using a traditional metal carpule syringe and a 27-gauge, 35 mm Effitec needle following the standard inferior alveolar nerve block technique.

Device: Infiltration Anesthesia with a Metal Cartridge Syringe; Device: Mandibular Block Anesthesia with a Metal Cartridge Syringe

Interventions

Digital Anesthesia with SleeperOne 5 DEVICE

For both maxillary and mandibular teeth, 1.7 mL of Ultracaine D-S Fort carpule (4% articaine with 1:200,000 epinephrine) was administered in two stages (gingival and intraosseous injection) using a computer-controlled intraosseous anesthesia system with a 30-gauge, 9 mm Effitec needle.

Also known as: SleeperOne 5

Digital Dental Anesthesia (CCLAD - Computer Controlled Local Anesthetic Delivery)

Infiltration Anesthesia with a Metal Cartridge Syringe DEVICE

For maxillary teeth, buccal infiltration is performed using a metal carpule syringe and a 30G, 16 mm Effitec needle (Dental Hi Tec, France); after aspiration, Ultracaine D-S Fort is slowly injected over 1 minute.

Also known as: Supraperiosteal Anesthesia

Traditional Local anesthesia Techniques

Mandibular Block Anesthesia with a Metal Cartridge Syringe DEVICE

For mandibular teeth, the injection site is dried, and a 27G, 35 mm Effitec needle (Dental Hi Tec, France) is inserted between the pterygomandibular raphe and internal oblique ridge, aligned with contralateral molars. After aspiration, Ultracaine D-S Fort is slowly injected over 1 minute using a traditional metal carpule syringe, following the standard mandibular block technique.

Also known as: IANB

Traditional Local anesthesia Techniques

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients classified as ASA I in general systemic health
• Children between 7 and 10 years of age
• Absence of any syndromic condition
• No physical or mental disability
• No prior dental treatment experience
• Frankl Behavior Rating Scale Class III or IV
• Presence of carious lesions limited to less than one-third of the buccolingual distance between cusp tips on the occlusal surfaces of primary or permanent molars on both sides
• Radiographic evidence of caries involving up to half of the dentin thickness with intact dentin at the pulp-dentin border in primary or permanent molars on both sides
• Teeth on both sides responding positively to pulp vitality tests, with no periradicular pathology or significant widening of the lamina dura on periapical radiographs

You may not qualify if:

• Patients with mild or severe systemic diseases or those undergoing medical treatment
• Patients younger than 7 or older than 10 years of age
• Uncooperative or noncompliant patients classified as Class I or Class II according to the Frankl Behavior Rating Scale
• Patients requiring urgent dental treatment
• Patients with wide carious lesions extending beyond one-third of the buccolingual distance between cusp tips on the occlusal surfaces
• Patients with carious lesions limited to less than one-third of the buccolingual width only on one side of the jaw
• Teeth with carious lesions not reaching half of the dentin thickness on radiographic evaluation or lacking intact dentin at the pulp border
• Teeth that do not respond positively to pulp vitality tests, or that show periradicular lesions or marked widening of the lamina dura on periapical radiographs

Sponsors & Collaborators

• Dicle University: lead

Study Sites (1)

Dicle University Faculty of Dentistry, Department of Pediatric Dentistry

Diyarbakır, 21300, Turkey (Türkiye)

Location

Related Links

• VAS (Visual Analog Scala):
• WBS (Wong-Baker Facesl Pain Rating Scale)
• flacc scale

MeSH Terms

Interventions

Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Emin C Tümen

  Dicle Universty

  STUDY DIRECTOR

Central Study Contacts

Hasan S Şener

CONTACT

+905301507384; dtsaidsener@gmail.com

Merve Güngör

CONTACT

+905301556358; dt.mervegunes92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asisstant

Model Details: The study was a single-center randomized controlled trial using a split mouth design

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: September 5, 2025
• Study Start: October 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 3 months after publication of results
• Access Criteria: dentists, medicine doctors

Locations

TU (1)