Intraseptal and Periodontal Ligament Anaesthesia for Tooth Extraction in Patients With Type 2 Diabetes
Efficacy and Safety of Intraseptal and Periodontal Ligament Anaesthesia for Extraction of Upper Lateral Incisors and Lower First Premolars in Patients With Type 2 Diabetes Mellitus
The goal of this clinical trial is to compare two local anesthesia techniques, intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA), in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.
The main questions it aims to answer are:
Which technique provides more effective local anesthesia for tooth extraction? Do ISA and PLA differ in their effects on blood pressure and heart rate during the procedure?
Researchers will compare ISA and PLA to determine which method is more effective and safer in this patient population.
Participants will:
Receive local anesthesia (ISA or PLA) using articaine with epinephrine delivered with a computer-controlled system Undergo extraction of a maxillary lateral incisor or mandibular first premolar Have blood pressure and heart rate measured before, during, and after anesthesia and extraction
調査の概要
詳細な説明
This randomized clinical trial was designed to evaluate and compare the clinical efficacy and safety of intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA) in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.
Local anesthetic administration in diabetic patients requires careful consideration due to potential cardiovascular responses and altered tissue sensitivity. Alternative injection techniques such as ISA and PLA may provide effective anesthesia while minimizing systemic effects.
A total of 120 participants were randomly assigned to receive either ISA or PLA. All anesthetic procedures were performed using a computer-controlled local anesthetic delivery system (CCLADS) with 0.6 mL of 4% articaine with 1:100,000 epinephrine (Septanest).
The study included extraction of maxillary lateral incisors and mandibular first premolars. Outcomes included anesthetic success rate, onset time, duration and extent of anesthesia, as well as changes in systolic and diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after the procedure.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Vojvodina
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Pančevo、Vojvodina、セルビア
- Faculty of Dentistry in Pančevo, University of Business Academy in Novi Sad
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Controlled Type 2 diabetes mellitus
- Age 35-77 years
- Patients requiring extraction of maxillary lateral incisors or mandibular first premolars
- Teeth free of acute periodontal disease
- No acute dentoalveolar abscess
- No dental treatment within last 48 hours
- No smoking
- No alcohol or drug dependence
- No contraindications to local anesthetic or vasoconstrictor
Exclusion Criteria:
- Smokers
- Patients with alcohol or drug dependence
- Contraindications to local anesthetics or vasoconstrictors
- Acute periodontal disease at the site of injection
- Acute dentoalveolar abscess
- History of tooth trauma or hypersensitivity in target teeth
- Dental treatment within the last 48 hours prior to procedure
- Non-controlled diabetes mellitus (implied, since study includes controlled DM only
研究計画
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：ISA (Intraseptal Anaesthesia)
Participants received intraseptal anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
|
0.6 mL of 4% articaine with 1:100,000 epinephrine administered for intraseptal anaesthesia (ISA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
|
|
実験的：PLA (Periodontal Ligament Anaesthesia)
Participants received periodontal ligament anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
|
0.6 mL of 4% articaine with 1:100,000 epinephrine administered for periodontal ligament anaesthesia (PLA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
|
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 |
|---|---|---|
|
Anesthetic success rate
時間枠：During tooth extraction procedure (5 minutes after administration of local anaesthesia).
|
Anesthetic success rate of intraseptal anaesthesia (ISA) compared with periodontal ligament anaesthesia (PLA) during extraction of maxillary lateral incisors and mandibular first premolars in patients with controlled Type 2 diabetes mellitus.
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During tooth extraction procedure (5 minutes after administration of local anaesthesia).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Onset time of local anesthesia
時間枠：Immediately after administration of local anesthesia (during procedure)
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Time from completion of anesthetic injection to the establishment of profound anesthesia in adjacent gingival tissue.
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Immediately after administration of local anesthesia (during procedure)
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|
Duration of soft tissue anesthesia
時間枠：During and after procedure (measured at 5-minute intervals until sensation returns)
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Time period from onset of anesthesia until return of sensation confirmed by pinprick testing in buccal attached gingiva.
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During and after procedure (measured at 5-minute intervals until sensation returns)
|
|
Width of anesthetic field
時間枠：10 minutes after successful anesthesia
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Extent (in millimeters) of anesthetized area in buccal/lingual/palatal attached gingiva and oral mucosa measured using pinprick testing and a flexible ruler.
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10 minutes after successful anesthesia
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Systolic blood pressure changes
時間枠：Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
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Changes in systolic blood pressure before, during, and after administration of local anesthesia.
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Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
|
|
Diastolic blood pressure changes
時間枠：Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
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Changes in diastolic blood pressure during perioperative period of anesthesia administration.
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Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
|
|
Mean arterial pressure changes
時間枠：Baseline to 30 minutes post-injection
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Changes in mean arterial pressure during and after administration of local anesthesia.
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Baseline to 30 minutes post-injection
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Heart rate changes
時間枠：Baseline, during injection, and 5, 10, 15, 30 minutes after administration
|
Changes in heart rate during and after administration of local anesthesia using ECG monitoring.
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Baseline, during injection, and 5, 10, 15, 30 minutes after administration
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協力者と研究者
捜査官
- 主任研究者：Vladimir Biocanin、Faculty of Dentistry in Pancevo, Department of Oral Surgery, University of Business Academy in Novi Sad, Serbia
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- No.36/3
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?
IPD プランの説明
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
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