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

2026年5月5日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

90

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Cairo、エジプト、11411
        • Faculty of Dentistry,Cairo University
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

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.

実験的: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.

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.

アクティブコンパレータ:Inferior alveolar nerve block Injection using the Conventional Syringe.
A conventional metal aspirating 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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Subjective pain during injection
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective pain during injection
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Mahmoud H Eid, Professor、Cairo University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年5月1日

一次修了 (推定)

2026年8月1日

研究の完了 (推定)

2027年8月1日

試験登録日

最初に提出

2026年4月30日

QC基準を満たした最初の提出物

2026年4月30日

最初の投稿 (実際)

2026年5月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月8日

QC基準を満たした最後の更新が送信されました

2026年5月5日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • anesthesia technique-2026

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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