Dental Anxiety, Pain, Pulpal Diseases
Conditions
Brief summary
This study aims to compare the effects of computer-controlled local anesthesia and conventional inferior alveolar nerve block on dental anxiety and pain in children undergoing pulpectomy of mandibular primary molars. Both anesthesia techniques are routinely used in pediatric dental practice and are considered standard methods of care. Children aged 6 to 8 years who require bilateral pulpectomy of mandibular primary molars will be included in this split-mouth randomized clinical trial. Each participant will receive both anesthesia techniques during separate treatment sessions. Dental anxiety, pain, and physiological parameters, including heart rate, blood pressure, oxygen saturation, and body temperature, will be assessed before, during, and after treatment using validated pediatric assessment scales and routine clinical measurements. The findings of this study may help identify the anesthesia technique that provides greater comfort and reduces anxiety and pain during pediatric dental treatment, thereby improving the overall treatment experience for children.
Interventions
PROCEDUREComputer-Controlled Local Anesthesia
Computer-controlled delivery of local anesthetic for mandibular primary molar pulpectomy.
PROCEDUREConventional Inferior Alveolar Nerve Block
Conventional inferior alveolar nerve block administered with a standard dental syringe for mandibular primary molar pulpectomy.
DRUGArticaine hydrochloride with epinephrine 1:100,000
A 4% articaine hydrochloride solution with epinephrine 1:100,000 was used as the local anesthetic solution in both study groups.
A computer-controlled local anesthetic delivery device was used to deliver the anesthetic solution at a constant, pre-programmed injection rate.
DEVICEStandard Dental Aspirating Syringe
A conventional dental aspirating syringe was used for manual administration of the local anesthetic solution.
Sponsors
Recep Tayyip Erdogan University Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The behavioral pain assessment (FLACC score) will be performed by an independent outcome assessor who is blinded to the local anesthesia technique used. Due to the nature of the interventions, participants and treating clinicians cannot be blinded.
Eligibility
Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 6 to 8 years. * Requiring bilateral pulpectomy treatment of mandibular primary molars. * Frankl Behavior Rating Scale score of 3 or 4. * American Society of Anesthesiologists (ASA) Physical Status I. * No known allergy to local anesthetic agents. * No previous experience with dental local anesthesia. * No signs of acute abscess or swelling in the treatment area. * Parent or legal guardian able to provide written informed consent and child willing to participate.
Exclusion criteria
* ASA Physical Status II or higher. * Known allergy or contraindication to local anesthetic agents. * Frankl Behavior Rating Scale score of 1 or 2. * Children receiving psychological or psychiatric treatment. * Physical or intellectual disabilities that could interfere with study procedures. * Previous experience with dental local anesthesia. * Presence of acute abscess, cellulitis, or diffuse swelling in the treatment area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental Anxiety | Baseline and immediately after treatment | Dental anxiety assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Higher scores indicate higher levels of dental anxiety. |
| Behavioral Pain During Local Anesthesia | Immediately after local anesthetic injection | Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale during local anesthesia administration. Scores range from 0 to 10, with higher scores indicating greater pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Pain | Immediately after local anesthetic injection | Pain assessed using the Wong-Baker FACES Pain Rating Scale immediately after treatment. Self-reported pain assessed using the Wong-Baker FACES Pain Rating Scale (0-10) immediately after completion of pulpectomy. Scores range from 0 to 10, with higher scores indicating greater pain intensity. |
| Facial Image Scale (FIS) Score | Baseline and immediately after treatment. | Emotional status assessed using the Facial Image Scale (FIS). Higher scores indicate greater anxiety. Emotional status assessed using the Facial Image Scale (FIS). The scale ranges from 1 to 5, with 1 indicating no anxiety (very happy face) and 5 indicating severe anxiety (very unhappy face). Higher scores indicate greater anxiety. |
| Heart Rate | Baseline and during local anesthetic administration | Heart rate measured using a pulse oximeter. |
| Blood Pressure | Baseline, during local anesthetic administration, and immediately after treatment | Systolic and diastolic blood pressure measured with an automated monitor. |
| Peripheral Oxygen Saturation (SpO₂) | Baseline, during local anesthetic administration, and immediately after treatment | Peripheral oxygen saturation measured using pulse oximetry. |
| Body Temperature | Baseline, during local anesthetic administration, and immediately after treatment | Body temperature measured using a digital thermometer. |
Countries
Turkey (Türkiye)
Contacts
CONTACTdilara nil günaçar
Outcome results
None listed