Comparison of Pain and Anxiety Associated with Digital and Conventional Local Anesthesia Injection in Maxillary Primary Canine Teeth in Children Aged 5 to 9 Years

To investigate and compare the anxiety and pain levels associated with digital and conventional local anesthesia injections in the maxillary primary canine teeth of children aged 5 to 9 years. The study will assess heart rate, the Wong‑Baker, FACES with results analyzed separately for boys and girls

42 children randomized into groups A & B for alternating digital/conventional anesthesia. Selection via sealed envelopes by blinded secretary. Visits spaced 7-14 days apart. Benzocaine gel pre-injection, both methods use 1:80000 lidocaine. Pain/anxiety assessed by Wong-Baker FACES and FLACC scales.

The study will be conducted in the Pediatric Dentistry Department of Kerman Dental School (1404-1405). Participants will be randomly divided into two groups. The department secretary (blinded) will select the treatment card, and the resident (blinded) will perform the injection. The second visit will be conducted 7 to 14 days later by the same resident. Parents will provide consent before treatment.

A study will be conducted on 42 children aged 5 to 9 years visiting the pediatric dentistry department of Kerman Dental School during the academic year 1404–1405. Inclusion criteria: Need for anesthesia in both primary maxillary canines, ability to communicate, parental consent, and Frankl behavior rating of 3 or 4. Exclusion criteria: Consumption of analgesics in the past 48 hours, previous dental treatment history, behavioral problems, systemic diseases, or contraindications for local anesthesia.

Before injection, benzocaine gel is applied for 1-2 minutes. For digital anesthesia, a 9mm gauge 30 needle is used, and for conventional anesthesia, a 16mm gauge 30 needle is used. Both methods are performed with a lidocaine solution containing 1:80000 epinephrine.

Anxiety and pain levels.

In this study, participants are individually assigned to one of two treatment groups (A and B) using simple randomization with sealed envelopes; for this purpose, 42 cards (21 for treatment A and 21 for treatment B) were prepared, placed in sealed envelopes, and put into a box. Subsequently, the department secretary, unaware of the envelopes’ contents, randomly selects one envelope per participant without replacement, and the corresponding treatment is administered by a pediatric resident in the first visit (conventional for A, digital for B), with the second visit (digital for A, conventional for B) occurring 7 to 14 days later by the same resident; this process ensures allocation concealment.

In this study, blinding has been implemented to prevent potential bias in participant responses. Participants will be unaware of which type of anesthesia intervention (digital or conventional) they are receiving during each visit. However, it should be noted that the resident responsible for administering the injections and assessing outcomes (pain and anxiety) is aware of the patients’ treatment group allocation.

all collected deidentified IPD

starting 12 months after publication

The data will be available to all requesters, including researchers and administrators.

Data can be used solely for meta-analysis studies.

Applicants should email the corresponding author.

Applicants should solely email the corresponding author, providing the title of their meta-analysis study and, if registered in PROSPERO, the PROSPERO code.