Dental Anesthesia, Dental Anxiety, Pain Management, Pediatric Dentistry
Conditions
Brief summary
This study aims to compare two different techniques of administering dental anesthesia to pediatric patients to determine which method causes less pain and anxiety during procedures like primary tooth extractions.
Detailed description
Dental anxiety, particularly in pediatric patients, is a significant challenge, often triggered by fear of local anesthesia injections. Although local anesthesia aims to prevent pain during treatment, the injection process itself can cause anxiety and defensive behaviors, especially in children. To address this, various methods have been introduced to reduce discomfort, including topical anesthetics, slow injections, and thinner needles. However, traditional methods still face challenges in regulating injection rates, leading to the development of computer-controlled local anesthetic delivery (CCLAD) systems. CCLAD, particularly intraosseous anesthesia systems like SleeperOne™, offer a controlled flow rate and pressure during anesthesia delivery, potentially reducing discomfort and anxiety. Despite numerous studies, results on the effectiveness of CCLAD in pediatric patients remain controversial. This study aims to bridge this gap by comparing the efficacy of computerized intraosseous anesthesia with conventional infiltration anesthesia in pediatric patients undergoing primary molar extraction. The goal is to assess pain perception and anxiety levels, with the hypothesis that intraosseous anesthesia may lead to better outcomes in terms of pain and anxiety reduction compared to conventional techniques. The use of the SleeperOne™ device for intraosseous anesthesia is hypothesized to be more effective in reducing pain and anxiety compared to conventional infiltration techniques during the extraction of primary molars in children.
Interventions
DEVICESleeperOne™
Computerized intraosseous anesthesia was delivered using the SleeperOne™ (Dental HiTec, France) device with a 30 G × 9 mm Effitec needle at a 15° angle to the mucosa. A total of 2 mL 2% articaine with 1:100,000 epinephrine was administered per site.
OTHERConventional Infiltration Anesthesia
The intervention for the Conventional Infiltration Anesthesia involves the manual administration of a local anesthetic using a standard dental syringe with a fine-gauge needle.
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Patients in between 6-12 years old * Physically and mentally healthy patients * Cooperative patients who were rated as positive or definitely positive according to the Frankl behavior classification scale * Patients who had primary molars that required extraction on both sides of maxillary arch.
Exclusion criteria
* Children allergic to local anesthetics * Medically compromised and special children * Teeth with hypoplasia * Children who used analgesic drug 48 hours before treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Perception - Visual Analogue Scale | During anesthesia and during extraction in each visit. | Pain was assessed using a 10-centimeter Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. |
| Pain Perception - Wong-Baker Faces Pain Rating Scale | During anesthesia and during extraction in each visit. | Pain was assessed using the Wong-Baker Faces Pain Rating Scale (WBPRS), which ranges from 0 (no hurt) to 10 (hurts worst). Higher scores indicate worse pain. |
| Dental Anxiety - State-Trait Anxiety Inventory for Children - State Subscale | At baseline, after anesthesia and after extraction in each visit. | Dental anxiety was assessed using the short form of the State-Trait Anxiety Inventory for Children - State Subscale (STAI-S). Scores range from 10 (low anxiety) to 40 (high anxiety). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physiological Arousal During Dental Procedure - Heart Rate | Before anesthesia, during anesthesia, and during extraction in each visit. | Heart rate was measured using a pulse oximeter to monitor physiological arousal during the procedure. Heart rate may reflect a combination of pain, anxiety, and procedural stress. Unit of Measure is beats per minute (bpm). Higher values may indicate increased physiological arousal. |
| Baseline Dental Anxiety Assessed by Children's Fear Survey Schedule - Dental Subscale (CFSS-DS) | At the baseline before starting first visit. | Baseline dental anxiety was assessed using the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS), which includes 15 items scored from 1 to 5. Total scores range from 15 to 75. Higher scores indicate greater dental fear. |
Countries
Turkey (Türkiye)
Outcome results
None listed