Traditional Local AnesthesiaComputer-controlled Electronic AnesthesiaDental AnxietyAnxiety in Children
Investigational drug(s) / intervention(s)
Digital Anesthesia with SleeperOne 5Infiltration Anesthesia with a Metal Cartridge SyringeMandibular Block Anesthesia with a Metal Cartridge Syringe
Digital Anesthesia with SleeperOne 5: 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.
Infiltration Anesthesia with a Metal Cartridge Syringe: 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.
Mandibular Block Anesthesia with a Metal Cartridge Syringe: 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.
Study 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.
Eligibility
Sex
ALL
Min age
7 Years
Max age
10 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
To assess the patient's pain level (Before and after anesthesia) — through study completion, an average of 6 month. 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".
To assess the patient's pain level (During anesthesia) — through study completion, an average of 6 month. 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.
To assess the patient's pain level (During anesthesia) — through study completion, an average of 6 month. 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.
To assess the patient's anxiety level (Before anesthesia ) — through study completion, an average of 6 month. 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
To assess the patient's anxiety level (Before and after anesthesia) — through study completion, an average of 6 month. 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.
Pulse rate measurement to assess patient's dental anxiety (Before,after and during anesthesia) — through study completion, an average of 6 month. Measurement will be made with a pulse oximeter.The measurement will be performed using a pulse oximeter attached to the patient's fingertip.
Blood oxygen saturation measurement to assess patient's dental anxiety (Before,after and during anesthesia) — through study completion, an average of 6 month. Measurement will be made with a pulse oximeter.The measurement will be performed using a pulse oximeter attached to the patient's fingertip.
Body temperature measurement to assess the patient's anxiety (Before,after and during anesthesia) — through study completion, an average of 6 month. 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.
Trial sites (1)
Facility
City
Region
Status
Dicle University Faculty of Dentistry, Department of Pediatric Dentistry
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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