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病変歯の治癒に対するさまざまな充填技術の影響を調べる

2026年9月26日 更新者:Ipek Eraslan Akyuz、TC Erciyes University

根尖病変のある歯の根尖切除後の治癒に対する三酸化ミネラル骨材の直行性と逆行性の塗布の効果の比較

Microorganisms are an important factor in the development of periradicular diseases. The goal of non-surgical endodontic treatment is to eliminate microorganisms and their byproducts from the root canal system and to create an effective barrier between the root canal system and surrounding tissues. If there is no healing in the periradicular tissues after non-surgical endodontic treatment or if retreatment becomes impossible, surgical endodontic treatment is required. Apical resection is a surgical technique that involves removing the root tip of the tooth and closing the apical portion of the root canal system. An ideal retrograde filling material should be non-toxic, non-carcinogenic and biocompatible. It must also have dimensional stability and sealing properties. Amalgam, glass ionomer cements, and zinc oxide-eugenol based materials have been used for root end fillings in periapical surgery, but the desired success was not achieved. Today, Mineral Trioxide Aggregate (MTA) is preferred as a retrograde filling material due to its superior sealing properties, ability to harden in the presence of blood and moisture, antibacterial effects, biocompatibility and radiopacity.

In the researchers' study, the effect of apical resection after orthograde canal filling and retrograde canal filling during apical resection on postoperative recovery will be compared. In both canal filling techniques, Sure-Seal Root MTA (Sure Dent Corporation-Korea) will be used as the filling material. Sure-Seal Root MTA is a calcium silicate based paste that is typically pre-mixed and ready to apply, exhibits excellent physical properties and does not show shrinkage during the curing process. As the manufacturer states, it is hydrophilic, biocompatible, has ideal setting and working time.

Our faculty has piezosurgical ultrasonics (Mectron ®, Grassobbio BG, Italy). After the root tip resection is performed, the retrograde cavity will be prepared with Woodpecker ultrasonic tips (Guilin, China) compatible with this device. In our study using these materials and devices, a comparative analysis of the effects of different canal filling techniques on lesion healing and improvement in clinical symptoms will be made.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Periapical or periradicular lesions are barriers that restrict microorganisms and prevent their spread to surrounding tissues; microorganisms cause periapical lesions, either primary or secondary. Apical infections, if left untreated, can follow two different paths: First, the infection can create a path inside or outside the mouth, causing the pus to drain out. Secondly, infection within the canal; It may reach the periapical tissues and create a cavity surrounded by polymorphonuclear leukocytes in the bone, leading to the formation of inflammatory radicular cysts.

Inflammatory radicular cysts (IRCs) are chronic lesions that occur after the development of periapical granulomas (PGs). PGs and IRCs are thought to follow pulp infections as an inflammatory process at the periapical level. Although both conditions, PG and IRC, are clinically diagnosed as apical periodontitis (AP), they differ significantly histopathologically.

The majority of apical cysts are asymptomatic and may develop insidiously by being discovered incidentally during a routine x-ray examination as a large periapical radiolucency covering the apex of one or more teeth. By confirming that the lesion is a granuloma or cyst, a more definitive diagnosis is reached by histopathological examination. Although conventional radiographic methods cannot be used for the definitive diagnosis of periapical cysts, larger round or oval, well-circumscribed radiolucent images around the apex of the tooth are considered to be cystic lesions.

When the infection in the canal is successfully treated, apical cysts can regress by the apoptosis mechanism in the root canal without the need for surgical intervention. Researchers stated that incorrect histopathological diagnosis in early studies created the false impression that radicular cysts were more common, and that this methodological error led to the illusion that most cystic lesions in the periapex area healed after non-surgical root canal treatment. In conclusion, the authors suggested that true cysts may be less likely to heal with nonsurgical root canal treatment due to their inherently self-sustaining properties and may require surgical intervention. Whether true cysts heal after non-surgical root canal treatment is still a major debate.

Different retrograde canal filling materials have been tried in the literature, but today, Mineral Trioxide Aggregate (MTA) is most commonly used because it is more biocompatible and has a periapical healing-inducing effect. MTA; It is the first restorative material that allows cementum development and provides regeneration in periodontal ligament cells. In addition, histological sections taken from the periapical region of teeth with retrograde canal filling with MTA often showed new cementum formation not only on the resection surface but also directly on the MTA. For this reason, MTA is called bioactive material. Properties of MTA such as biocompatibility, sealing, and the capacity to increase the regeneration of pulp and periradicular tissues; It has increased the diversity of dental usage areas and clinical success rates, and has become the focus of attention of clinicians with this innovative structure. In comparative studies on retrograde filling materials, MTA has demonstrated an excellent tissue response with almost no inflammatory component.

There are few studies in the literature comparing the effects of two different canal filling techniques (orthograde, retrograde), which are currently frequently used, on postoperative recovery. There is no study comparing the long-term postoperative radiographic and clinical improvement levels of using MTA with different application techniques in teeth with periapical lesions with an indication for apical resection. The purpose of researchers' planned study is to compare and evaluate the healing effect of orthograde MTA application followed by resection in teeth with large periapical lesions and retrograde MTA application during apical resection operation.

研究の種類

介入

入学 (実際)

60

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。

研究場所

    • Kayseri
      • Kayseri、Kayseri、トルコ(Türkiye)、38039
        • Erciyes Üniversitesi Diş Hekimliği Fakültesi

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

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion criteria

1. Patients aged between 18 and 65 years with persistent symptomatic apical pathology, characterized by pain on biting and/or percussion sensitivity, who provided written informed consent for the surgical procedure and follow-up examinations.

2. Patients with a non-contributory medical history, classified as American Society of Anesthesiologists (ASA) Class I or II.

3. Single-rooted anterior teeth with true endodontic lesions classified as Type B or C according to Kim and Kratchman's classification (Table 1).1 4. Single-rooted anterior teeth without significant canal calcification or obliteration, significant root curvature, or anatomical abnormalities.

5. Teeth deemed restorable with sufficient remaining coronal structure to support a definitive restoration.

6. Periodontally healthy teeth, defined as probing depths ≤ 6 mm, absence of pathological mobility, and no furcation involvement Exclusion criteria

  1. Patients with systemic diseases that contraindicate surgical procedures (e.g., uncontrolled diabetes, coagulation disorders, immunosuppression).
  2. Patients taking medications that may affect bone metabolism or healing (e.g., bisphosphonates, corticosteroids, anticoagulants).
  3. Pregnant or breastfeeding patients.
  4. Teeth with vertical root fractures, perforations, or external root resorption.
  5. Teeth with insufficient bone support or an unfavorable crown-to-root ratio as determined by clinical and radiographic assessment.
  6. Patients who declined follow-up participation or were unable to commit to the scheduled follow-up examinations.
  7. Teeth in which orthograde MTA obturation could not be completed intraoperatively due to anatomical limitations were to be excluded from analysis; however, no such cases were encountered in this trial.

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: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
アクティブコンパレータ:Retrograde canal filling technique

Apical resection application after retrograde root canal filling

Apical resection application after root canal filling

アクティブコンパレータ:Orthograde canal filling technique

Apical resection application after orthograde root canal filling

Apical resection application after root canal filling

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
Comparison of lesion healing rate after apical resection using different root canal filling techniques
時間枠:2 years

lesion healing rate

2 years

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

  • 主任研究者:ERASLAN AKYÜZ、BAŞ ARAŞTIRMACI
  • スタディディレクター:TOPÇUOĞLU、YÜRÜTÜCÜ
  • スタディチェア:ÖZDEMİR、YARDIMCI ARAŞTIRMACI

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 (実際)

2024年5月8日

一次修了 (実際)

2026年8月5日

研究の完了 (実際)

2026年8月25日

試験登録日

最初に提出

2024年4月18日

QC基準を満たした最初の提出物

2024年4月22日

最初の投稿 (実際)

2024年4月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月30日

QC基準を満たした最後の更新が送信されました

2026年9月26日

最終確認日

2026年9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

  • 2024/56

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

米国で製造され、米国から輸出された製品。

いいえ

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