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Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe

5 maggio 2026 aggiornato da: Yasmeen Mohamed Hussein Mohamed Amer, Cairo University

Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe: A Randomized Controlled Clinical Trial

This RCT study aims to establish evidence based decision comparing between Vibraject (MiltexInc LLC.,York,PA,USA).and Dental vibe(BING Innovations LLC,Crystal Lake,IL,USA versus Conventional Syringe on pain perception during inferior alveolar nerve block anesthesia in lower primary molars indicated for extraction,pulp therapy and cavity preparation in Children.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This randomized controlled clinical trial aims to compare pain perception of Vibraject and dental vibe during inferior alveolar nerve block in lower primary molars indiacted for extraction,pulp therapy and cavity preparation in children aged 6-8 years.

Pain during local anesthesia remains a major concern in pediatric dentistry, as it contributes significantly to fear, anxiety, and uncooperative behavior in children. Vibration devices, based on the gate control theory of pain, have been introduced as a non-pharmacological method to reduce injection discomfort.

Ninety children will be randomly allocated into 3 parallel groups(1:1:1): Inferior alveolar nerve block Injection using Vibraject system,Inferior alveolar nerve block Injection using Dentalvibe system, Inferior alveolar nerve block Injection using the Conventional Syringe.

All participants will undergo standardized procedures, including topical anesthesia application followed by local anesthetic injection using articaine. Pain perception during injection will be assessed using both subjective and objective measures.

The primary outcome is subjective pain perception during injection measured using Wong-Baker Scale,While secondary outcome is objective pain perception during injection measured using FLACC Scale,Finally The Physiological parameters(heart rate, oxygen saturation )will be measured at two time points: baseline and during injection using pulse oximeter device on child's index finger.

The Findings of this study aims to provide evidence-based guidance on the optimal non pharmacological technique to enhance pain-controlled dental procedures allowing better quality of dental treatment and Improve the patient's cooperation and acceptance for future dental visits.

Tipo di studio

Interventistico

Iscrizione (Stimato)

90

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Egitto
      • Cairo, Egitto, 11411
        • Faculty of Dentistry,Cairo University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • Children aged 6-8 years.
  • Cooperative children (Rating 3 or 4 based on the Frankl behaviour scale).
  • Medically fit children (ASA I).
  • Children mentally capable of communication.
  • First dental visit (no previous history of injection of LA).
  • Patient requiring extraction/pulp therapy/cavity preparation in mandibular primary molars

Exclusion Criteria:

  • Uncooperative patient (other than 3 or 4 based on the Frankl behaviour scale).
  • Medically unfit children (other than ASA 1).
  • Parental refusal of participation.
  • Children under medications (antibiotics and analgesics) for the previous 48 hours that could alter the pain perception.
  • Children who are allergic to local anaesthesia.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Inferior alveolar nerve block Injection using Vibraject system(MiltexInc LLC.,York,PA,USA).
VibraJect is a compact, battery-operated unit that attaches directly to a standard dental syringe, generating high-frequency vibrations along the needle to attenuate pain during anesthetic delivery. If these devices prove efficacy, they may offer a rapid, non-pharmacologic method to enhance the comfort of children undergoing local anesthesia.
Dispositivo: Vibraject

Familiarize the child with the Vibraject device, allowing them to feel the vibrations on their hand to reduce anxiety.

Dry the injection site with sterile gauze. Apply 20% benzocaine gel for 1 minute using a cotton swab.

Use a conventional syringe with the Vibraject attachment, 4% articaine (1:100,000 epi), and a 27-gauge long needle.

Deliver an inferior alveolar and lingual nerve block. Slowly deposit 1.5 mL of anesthetic over at least 60 seconds to minimize discomfort.

Use the FLACC scale (objective) during injection and the Wong-Baker FACES scale (subjective) immediately after.

Monitor heart rate and oxygen saturation via pulse oximetry at baseline and during injection.

Confirm anesthesia after 3-5 minutes via numbness (subjective) and lack of pain during instrumentation (objective).

Perform (extraction or pulp therapy or cavity preparation) per AAPD guidelines. Provide post-operative instructions to the parent and evaluate the need for a space maintainer.
Sperimentale: Inferior alveolar nerve block Injection using Dentalvibe system (BING Innovations LLC,Crystal La).
The DentalVibe device is a cordless, rechargeable instrument that produces controlled, pulsed micro-vibrations at the injection site. It features a U-shaped vibrating tip connected to a microprocessor-driven VibraPulse motor, allowing gentle stimulation of sensory receptors, illumination of the injection area, and retraction of the cheek or lip.
Dispositivo: Dental vibe

Familiarize the child with the DentalVibe device, letting them feel the vibrations on the back of their hand.

Dry the mucosa with gauze and apply 20% benzocaine gel for 1 minute. Apply the DentalVibe to the buccal mucosa for pre-injection vibration. Using a conventional syringe (4% articaine, 1:100,000 epi, 27G needle), perform the mandibular block simultaneously while the DentalVibe is active.

Slowly deposit 1.5 mL (1.0 mL alveolar / 0.5 mL lingual) over at least 60 seconds.

Evaluate pain using the FLACC scale (during) and the Wong-Baker FACES scale (after).

Record heart rate and oxygen saturation at baseline and during the injection. After 3-5 minutes, confirm anesthesia via subjective numbness and objective lack of pain during instrumentation.

Perform treatment (extraction/pulp therapy/cavity prep) per AAPD guidelines. Provide post-operative care instructions and assess the need for space maintainers.
Comparatore attivo: Inferior alveolar nerve block Injection using the Conventional Syringe.
A conventional metal aspirating syringe
Dispositivo: Conventional syringe

Dry the injection site with sterile gauze. Apply 20% benzocaine gel for 1 minute using a cotton swab to ensure surface numbing.

Use a conventional metal aspirating syringe with 4% articaine (1:100,000 epi) and a 27-gauge long needle.

Deliver a mandibular inferior alveolar nerve block. Slowly deposit 1.5 mL total (1.0 mL for the alveolar nerve and 0.5 mL for the lingual nerve) over a minimum of 60 seconds.

Evaluate pain using the FLACC scale (during) and the Wong-Baker FACES scale (after).

Record heart rate and oxygen saturation at baseline and during the injection. After 3-5 minutes, confirm anesthesia via subjective numbness and objective lack of pain during instrumentation.

Perform (extraction, pulp therapy, or cavity preparation) according to AAPD guidelines.

Provide post-operative care instructions and evaluate the patient for potential space maintainer requirements.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Subjective pain during injection
Lasso di tempo: during injection
Wong-Baker Scale: represents a series of faces from a 0-value happy face (which represents lack of pain) to a 10-value crying face (which suggests the worst possible pain). On this basis, the patient chooses the face that best describes his/her level of pain.
during injection

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective pain during injection
Lasso di tempo: Baseline and during injection

Faces, Legs, Arms, Crying, Consolability (FLACC) scale: a measurement tool used to assess the intensity of pain for young children and infants or children that are unable to communicate their pain with exposed body and limbs. The scale is scored in a range of 0-10 with 0 representing no pain. The observation lasts for 2-5 minutes. Each parameter is evaluated on a scale from 0 to 2; the total score is interpreted as follows: 0=relaxed and comfortable, 1-3=mild discomfort, 4- 6=moderate pain, 7-10=severe discomfort/pain.

- Physiological parameters (heart rate, oxygen saturation ) at two time points: baseline, during injection using pulse oximeter Pulse oximetry: non-invasive monitoring technique that measures the heart rate and the oxygen saturation in the blood by shining light at specific wavelengths through tissue, most commonly the fingernail bed, pulse oximetry is the standard of care to use pulse oximetry to monitor oxygen saturation for patients receiving anesthesia.
Baseline and during injection

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cairo University

Investigatori

  • Direttore dello studio: Mahmoud H Eid, Professor, Cairo University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 agosto 2026

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • anesthesia technique-2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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