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EFFECT OF SUPER PEN COMPUTER-CONTROLLED INTRALIGAMENTARY INJECTION ON PAIN PERCEPTION IN PEDIATRIC PATIENTS UNDERGOING EXTRACTION OF PRIMARY MOLARS

2026年5月3日更新者：Shatha Musaad Alharthi

EFFECT OF SUPER PEN COMPUTER-CONTROLLED INTRALIGAMENTARY INJECTION ON PAIN PERCEPTION IN PEDIATRIC PATIENTS UNDERGOING EXTRACTION OF PRIMARY MOLARS (RANDOMIZED CONTROLLED CLINICAL TRIAL)

The aim of this study to evaluate the effectiveness of CC-ILA using Super pen in eliminating pain during the extraction of mandibular primary molars, compared to the conventional Inferior Alveolar Nerve Block (IANB).

調査の概要

状態

まだ募集していません

条件

痛みの知覚

介入・治療

デバイス：Experimental Group (CC-ILA using Super Pen)

研究の種類

介入

入学 (推定)

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

名前：Shatha M Alharthi, BDS
電話番号：+966541077444
メール：shatha.al-harthi@hotmail.com

研究場所

エジプト
- - Alexandria、エジプト
    - Faculty of Dentistry, Alexandria University, Egypt
    - コンタクト：
      
      Shatha AlHarthi, BDS
      
      電話番号：+966 54 107 7444
      
      メール：shatha.al-harthi@hotmail.com

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

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

Age 5-7 years.
Children free from systemic diseases or special healthcare needs (ASAI).14
No previous negative dental experiences.15
Positive or definitely positive preoperative behaviour, according to the Frankl Behaviour Rating Scale (scores 3 or 4) (Appendix I).16
Mandibular primary molars indicated for extraction.17,18
Parental consent to participate in the study.

Exclusion Criteria:

Root resorption exceeding one-third of root length or signs of mobility.
Fractured roots
Ankylosed roots.
Active infection or pathosis at the injection site.
History of allergy to local anesthetics.

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：支持療法
割り当て：ランダム化
介入モデル：並列代入
マスキング：独身

アーム数

武器と介入

参加者グループ / アーム	介入・治療
実験的：A) Experimental Group (CC-ILA using Super Pen) A) Experimental Group (CC-ILA using Super Pen) CC-ILA will be administered with the Super Pen according to manufacturer instructions. A standard 1.8 mL Articaine carpule will be used. The injection will be initiated at the distolingual line angle of the target tooth, with the needle inserted through the gingival sulcus at approximately a 30° angle to the long axis, bevel facing the alveolar bone. Approximately 0.2 mL of 4% Articaine with 1:100,000 epinephrine will be delivered per root.24 The visual pressure indicator will be monitored to ensure controlled delivery within optimal pressure ranges. Slight tissue blanching will indicate adequate deposition. The procedure will be repeated at the mesiolingual line angle.	デバイス：Experimental Group (CC-ILA using Super Pen) A standard 1.8 mL Articaine carpule will be used. The injection will be initiated at the distolingual line angle of the target tooth, with the needle inserted through the gingival sulcus at approximately a 30° angle to the long axis, bevel facing the alveolar bone. Approximately 0.2 mL of 4% Articaine with 1:100,000 epinephrine will be delivered per root. The visual pressure indicator will be monitored to ensure controlled delivery within optimal pressure ranges. Slight tissue blanching will indicate adequate deposition. The procedure will be repeated at the mesiolingual line angle.
アクティブコンパレータ：B) Control Group (Conventional IANB Technique) A 27-gauge 3 cm long needle will be used to administer Articaine 4% with 1:100,000 epinephrine via the standard IANB approach, followed by long buccal infiltration. After negative aspiration, approximately 1.0 mL of solution will be delivered near the inferior alveolar nerve, and 0.5 mL as a buccal infiltration distal to the second primary molar.25 Anesthesia onset will be confirmed by gingival probing at 10-second intervals (CC-ILA) or 30-second intervals (IANB).	デバイス：Experimental Group (CC-ILA using Super Pen) A standard 1.8 mL Articaine carpule will be used. The injection will be initiated at the distolingual line angle of the target tooth, with the needle inserted through the gingival sulcus at approximately a 30° angle to the long axis, bevel facing the alveolar bone. Approximately 0.2 mL of 4% Articaine with 1:100,000 epinephrine will be delivered per root. The visual pressure indicator will be monitored to ensure controlled delivery within optimal pressure ranges. Slight tissue blanching will indicate adequate deposition. The procedure will be repeated at the mesiolingual line angle.

参加者グループ / アーム

介入・治療

実験的：A) Experimental Group (CC-ILA using Super Pen)

A) Experimental Group (CC-ILA using Super Pen)

CC-ILA will be administered with the Super Pen according to manufacturer instructions.
A standard 1.8 mL Articaine carpule will be used. The injection will be initiated at the distolingual line angle of the target tooth, with the needle inserted through the gingival sulcus at approximately a 30° angle to the long axis, bevel facing the alveolar bone.
Approximately 0.2 mL of 4% Articaine with 1:100,000 epinephrine will be delivered per root.24
The visual pressure indicator will be monitored to ensure controlled delivery within optimal pressure ranges. Slight tissue blanching will indicate adequate deposition. The procedure will be repeated at the mesiolingual line angle.

デバイス：Experimental Group (CC-ILA using Super Pen)

A standard 1.8 mL Articaine carpule will be used. The injection will be initiated at the distolingual line angle of the target tooth, with the needle inserted through the gingival sulcus at approximately a 30° angle to the long axis, bevel facing the alveolar bone.
Approximately 0.2 mL of 4% Articaine with 1:100,000 epinephrine will be delivered per root.
The visual pressure indicator will be monitored to ensure controlled delivery within optimal pressure ranges. Slight tissue blanching will indicate adequate deposition. The procedure will be repeated at the mesiolingual line angle.

アクティブコンパレータ：B) Control Group (Conventional IANB Technique)

A 27-gauge 3 cm long needle will be used to administer Articaine 4% with 1:100,000 epinephrine via the standard IANB approach, followed by long buccal infiltration.
After negative aspiration, approximately 1.0 mL of solution will be delivered near the inferior alveolar nerve, and 0.5 mL as a buccal infiltration distal to the second primary molar.25
Anesthesia onset will be confirmed by gingival probing at 10-second intervals (CC-ILA) or 30-second intervals (IANB).

デバイス：Experimental Group (CC-ILA using Super Pen)

A standard 1.8 mL Articaine carpule will be used. The injection will be initiated at the distolingual line angle of the target tooth, with the needle inserted through the gingival sulcus at approximately a 30° angle to the long axis, bevel facing the alveolar bone.
Approximately 0.2 mL of 4% Articaine with 1:100,000 epinephrine will be delivered per root.
The visual pressure indicator will be monitored to ensure controlled delivery within optimal pressure ranges. Slight tissue blanching will indicate adequate deposition. The procedure will be repeated at the mesiolingual line angle.

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
Heart rate 時間枠：immediately after the procedure (within the same treatment visit)	Heart rate will be monitored using a pulse oximeter at baseline, during LA injection, and during extraction. Readings will be recorded every two minutes and mean values will be calculated.	immediately after the procedure (within the same treatment visit)
Oxygen saturation 時間枠：immediately after the procedure (within the same treatment visit)	Oxygen saturation will be monitored using a pulse oximeter at baseline, during LA injection, and during extraction. Readings will be recorded every two minutes and mean values will be calculated.	immediately after the procedure (within the same treatment visit)

二次結果の測定

結果測定	メジャーの説明	時間枠
Objective Pain assessment 時間枠：immediately after the procedure (within the same treatment visit).	Pain will be assessed using the Sound, Eye, and Motor (SEM) Scale. Each component will be graded from 1 (comfort) to 4 (severe discomfort) by the operator and the independent outcome assessor evaluator reviewing video recordings.	immediately after the procedure (within the same treatment visit).
Subjective Pain assessment 時間枠：immediately after the procedure (within the same treatment visit).	Pain perception will be recorded after anesthesia and Extraction using a modified facial expression scale. Children will choose from three schematic faces representing satisfaction, indifference, or dissatisfaction.	immediately after the procedure (within the same treatment visit).

その他の成果指標

結果測定	メジャーの説明	時間枠
Adverse Event Assessment 時間枠：24 hours	Parents will be questioned during the 24-hour follow-up regarding any unusual symptoms.	24 hours

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

Shatha Musaad Alharthi

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)

2026年8月1日

試験登録日

最初に提出

2026年5月3日

QC基準を満たした最初の提出物

2026年5月3日

最初の投稿 (実際)

2026年5月8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3日

最終確認日

2026年5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

1208-12/2025

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

EFFECT OF SUPER PEN COMPUTER-CONTROLLED INTRALIGAMENTARY INJECTION ON PAIN PERCEPTION IN PEDIATRIC PATIENTS UNDERGOING EXTRACTION OF PRIMARY MOLARS