Local Dexamethasone Administration in Symptomatic Irreversible Pulpitis (SIPDEX)
Comparison of the Effects of Submucosal and Intraligamentary Dexamethasone Administration on Anesthetic Success and Pain Control in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Symptomatic irreversible pulpitis is associated with a high incidence of inadequate pulpal anesthesia during endodontic treatment, particularly in mandibular molar teeth. Failure to achieve profound anesthesia may result in increased intraoperative pain and patient discomfort. Corticosteroids have been suggested as adjunctive agents to improve pain control and reduce inflammatory responses; however, the influence of different local administration techniques on anesthetic success and postoperative pain remains unclear.
The aim of this randomized controlled clinical trial is to compare the effects of submucosal and intraligamentary dexamethasone administration on anesthetic success and pain control in patients with symptomatic irreversible pulpitis. A total of 84 participants requiring root canal treatment of mandibular first or second molars diagnosed with symptomatic irreversible pulpitis will be randomly allocated to one of three groups: (1) inferior alveolar nerve block (IANB) followed by submucosal saline injection (control group), (2) IANB followed by submucosal dexamethasone injection, and (3) IANB followed by intraligamentary dexamethasone injection.
All participants will receive standardized endodontic treatment under local anesthesia. The primary outcome measure is anesthetic success during access cavity preparation and pulp extirpation. Secondary outcome measures include postoperative pain intensity at 6, 12, 24, 48, and 72 hours, and postoperative analgesic consumption. The results of this study may provide evidence regarding the effectiveness of different local dexamethasone administration techniques and contribute to improved pain management strategies in endodontic practice.
調査の概要
状態
詳細な説明
Symptomatic irreversible pulpitis is associated with a high incidence of failure of inferior alveolar nerve block anesthesia, particularly in mandibular molars, resulting in pain during endodontic treatment and the frequent need for supplemental anesthesia. Corticosteroids have been investigated as adjunctive agents because of their anti-inflammatory properties and their potential to improve anesthetic success and reduce postoperative pain. However, limited evidence is available regarding the influence of different local administration techniques on these outcomes.
This prospective, randomized, controlled, single-blind clinical trial aims to compare the effects of submucosal and intraligamentary administration of dexamethasone on anesthetic success and postoperative pain following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis of mandibular first or second molars.
Eighty-four participants will be randomly allocated into three parallel groups (28 participants per group):
Group 1 (Control): Inferior alveolar nerve block followed by submucosal injection of normal saline (placebo).
Group 2: Inferior alveolar nerve block followed by submucosal injection of dexamethasone.
Group 3: Inferior alveolar nerve block followed by intraligamentary injection of dexamethasone.
The primary outcome is anesthetic success, assessed using the Heft-Parker Visual Analog Scale (HP-VAS) during access cavity preparation and pulp extirpation. Secondary outcomes include postoperative pain intensity assessed using the HP-VAS at 6, 12, 24, 48, and 72 hours after treatment, as well as the need for postoperative analgesic medication. The findings of this study may help identify the most effective local administration technique for dexamethasone to improve anesthetic success and postoperative pain management in patients with symptomatic irreversible pulpitis.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Elif İrem Altıntaş, Research Assistant
- 電話番号：+905425491411
- メール：eialtintas@icloud.com
研究連絡先のバックアップ
- 名前：Ayşe Karadayı, Assistant Professor
- 電話番号：+905330527343
- メール：ayse.karadayi@marmara.edu.tr
研究場所
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Istanbul、トルコ（Türkiye）
- 募集
- Marmara University Faculty of Dentistry
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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:
- Patients aged 18 to 65 years.
- ASA I or ASA II systemic health status.
- Symptomatic irreversible pulpitis in a mandibular molar tooth.
- Positive response to pulp sensibility tests.
- Preoperative pain score greater than 54 mm on the Heft-Parker Visual Analog Scale (HP-VAS).
- Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Pregnancy or lactation.
- Allergy or contraindication to articaine, dexamethasone, or study-related medications.
- Use of analgesics, anti-inflammatory drugs, or antibiotics within the previous 12 hours.
- Presence of periapical radiolucency or diagnosis of pulpal necrosis.
- Significant systemic disease (ASA III or higher).
- Inability to complete pain assessment forms or follow study procedures.
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：Control Group
Participants receive an inferior alveolar nerve block followed by a submucosal saline injection prior to endodontic treatment.
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Normal saline is administered submucosally following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
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実験的：Submucosal Dexamethasone
Participants receive an inferior alveolar nerve block followed by submucosal dexamethasone administration prior to endodontic treatment.
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Dexamethasone (8 mg/2 mL) is administered submucosally following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
Dexamethasone (8 mg/2 mL) is administered intraligamentarily following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
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実験的：Intraligamentary Dexamethasone
Participants receive an inferior alveolar nerve block followed by intraligamentary dexamethasone administration prior to endodontic treatment.
|
Dexamethasone (8 mg/2 mL) is administered submucosally following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
Dexamethasone (8 mg/2 mL) is administered intraligamentarily following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
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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 |
|---|---|---|
|
Success of Inferior Alveolar Nerve Block Anesthesia
時間枠：Periprocedural (during access cavity preparation and pulp extirpation)
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Anesthetic success will be assessed using the Heft-Parker Visual Analog Scale (HP-VAS) during access cavity preparation and pulp extirpation.
Successful anesthesia is defined as no pain or mild pain (HP-VAS <54 mm) without the need for supplemental anesthesia.
Moderate or severe pain (HP-VAS ≥54 mm) or the need for supplemental anesthesia will be considered anesthetic failure.
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Periprocedural (during access cavity preparation and pulp extirpation)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postoperative Pain Intensity
時間枠：6, 12, 24, 48, and 72 hours after treatment
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Postoperative pain intensity will be assessed using the Heft-Parker Visual Analog Scale (HP-VAS) at 6, 12, 24, 48, and 72 hours after treatment.
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6, 12, 24, 48, and 72 hours after treatment
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Need for Postoperative Analgesic Medication
時間枠：Up to 72 hours after treatment
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The need for postoperative analgesic medication will be assessed by recording whether participants require rescue analgesic medication during the 72-hour follow-up period after treatment.
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Up to 72 hours after treatment
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- SIPDEX2026
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
米国FDA規制機器製品の研究
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