An interventional study of Intervention A: Buzzy® Bee-Assisted Local Anesthesia and Intervention B: Conventional Local Anesthesia Technique in Anesthesia, Anxiety and Pain, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 5 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
The present study will evaluate the effectiveness of Buzzy Bee in reducing pain and physiological responses during maxillary buccal infiltration in children aged 5-7 years compared with a conventional injection protocol.
Pain control during local anesthetic administration is essential in pediatric dentistry, as injection-related discomfort may increase anxiety and affect children's cooperation. The present study will evaluate the effectiveness of Buzzy Bee in reducing pain and physiological responses during maxillary buccal infiltration in children aged 5-7 years compared with a conventional injection protocol.
The study includes 40 children attending the Outpatient Clinic of the Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. A randomized crossover design will be used, with each child receiving both interventions during two visits separated by one week. Participants will be randomly allocated to the AB or BA sequence.
Both interventions involved topical application of 4% lidocaine hydrochloride gel for two minutes, followed by maxillary buccal infiltration using 4% articaine with epinephrine 1:200,000. The Buzzy Bee protocol incorporated external cold and vibration, whereas the conventional protocol used audiovisual distraction.
Heart rate will be recorded before, during, and after injection. Pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale and the Wong-Baker Faces Pain Rating Scale.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Tanta University is the lead sponsor of 987 studies on the registry; 313 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Participants in Sequence AB receive Buzzy® Bee-assisted maxillary buccal infiltration local anesthesia during the first visit (Period 1). After a 1-week washout period, the same participants receive local anesthesia using the conventional administration technique during the second visit (Period 2).
Device: Intervention A: Buzzy® Bee-Assisted Local Anesthesia · Drug: Intervention B: Conventional Local Anesthesia Technique
Participants in Sequence BA receive conventional maxillary buccal infiltration local anesthesia during the first visit (Period 1). After a 1-week washout period, the same participants receive Buzzy® Bee-assisted local anesthesia during the second visit (Period 2).
Device: Intervention A: Buzzy® Bee-Assisted Local Anesthesia · Drug: Intervention B: Conventional Local Anesthesia Technique
Behavioral Guidance: Child preparation using the Tell-Show-Do technique. Device Application: The Buzzy® Bee device (equipped with pre-frozen wings) is activated to provide combined high-frequency vibration and cryotherapy. It is placed on the extraoral cheek skin approximately 1-2 cm proximal to the target injection site for 30 seconds prior to needle insertion and remains continuously active throughout needle insertion and solution deposition. Topical Anesthesia: Injection site is isolated with cotton rolls, dried, and treated with 2% Lidocaine gel applied for 2 minutes via a sterile cotton swab. Local Anesthesia Injection: Maxillary buccal infiltration is delivered using 4% Articaine with 1:200,000 epinephrine via a sterile short 27-gauge needle, deposited slowly over 60 seconds while Buzzy® Bee is running.
Behavioral Guidance: Child preparation using standard Tell-Show-Do behavioral guidance paired with routine audiovisual distraction (cartoons displayed on a chair-side screen). Topical Anesthesia: Identical protocol to Intervention A (site isolation, drying, and 2% Lidocaine gel application for 2 minutes). Local Anesthesia Injection: Maxillary buccal infiltration delivered using 4% Articaine with 1:200,000 epinephrine via a sterile short 27-gauge needle, deposited slowly over 60 seconds using identical technique, volume, and rate as Intervention A, but without external vibration or cryotherapy application.
Self-Reported Pain Intensity (Wong-Baker FACES® Pain Rating Scale)
Subjective pain intensity assessed using the validated Wong-Baker FACES® Pain Rating Scale. The scale features six facial expressions ranging from 0 ("No Hurt") to 10 ("Hurts Worst") in increments of 2 (0, 2, 4, 6, 8, 10). Following local anesthesia administration, the child is seated upright and points to the face that best represents their pain intensity experienced during needle insertion. Higher scores represent higher pain intensity.
Time frame: Immediately post-injection (approx. 5 min post-baseline) at Visit 1 (Day 0) and Visit 2 (Day 7)
Physiological Anxiety / Stress Response (Heart Rate)
Physiological stress and anxiety evaluated continuously via a pediatric pulse oximeter attached to the child's index finger. Heart rate is recorded in beats per minute (BPM) at three standardized procedural milestones: Baseline: 2 minutes prior to local anesthetic administration while resting in the chair. During Injection: Exact moment of needle insertion and solution deposition. Post-Injection: Immediately following needle withdrawal.
Time frame: Baseline (2 minutes pre-injection), during injection (approx. 2-3 minutes post-baseline), and post-injection (approx. 5 minutes post-baseline) at Visit 1 (Day 0) and Visit 2 (Day 7).
Behavioral Pain Expression (FLACC Scale)
Objective behavioral pain expression assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale. Evaluated during the local anesthesia injection procedure by a trained independent observer (physically and via standardized video recording). Five categories are scored from 0 to 2, yielding a cumulative score ranging from 0 to 10: 0: Relaxed and comfortable 1-3: Mild discomfort 4-6: Moderate pain 7-10: Severe discomfort and/or pain Higher scores represent greater behavioral pain expression.
Time frame: During the local anesthesia administration procedure (approx. 2 to 3 minutes post basline) at Visit 1 (Day 0) and Visit 2 (Day 7).
Started Aug 2025 (actual). Primary completion is estimated for Oct 2026, 14 months after the start.
Of 2,720 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 14 months is close to that.
Counting every sponsor, half of 2,789 studies reached it within 12 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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