Effect of NeoSEALER FLO and AH Plus Resin Sealer on Postoperative Pain and Healing of Periapical Lesions
Effect of NeoSEALER FLO and AH Plus Resin Sealer on Postoperative Pain and Healing of Periapical Lesions: A Randomized Clinical Study
Tissue repair is an essential process that reestablishes tissue integrity and regular function. Nevertheless, different therapeutic factors and clinical conditions may interfere in this process of periapical healing.The success of root canal treatment is affected by the correct choice of clinical protocol.
These factors are dependent on the sanitization process (instrumentation, irrigating solution, irrigating strategies, and intracanal dressing) the apical limit of the root canal preparation and obturation, and the quality of the sealer. The challenges affecting the healing process of endodontically treated teeth include control of the inflammation of pulp or infectious processes and simultaneous neutralization of unpredictable provocations to the periapical tissue.
調査の概要
詳細な説明
The goal of root canal obturation is to obtain complete sealing to hinder the communication between the root canal and the periapical tissue. This favors the process of apical and periapical repair after endodontic therapy.An ideal root canal sealer must have adequate physical, chemical, and biological properties.
Several factors can affect the success of RCT, including the type and composition of sealer utilized. The presence and release of substances from the sealers can cause different reactions when in contact with tissue.
AH Plus, an epoxy resin-based sealer, is considered the gold standard among root canal sealers due to its excellent physical, chemical, and biological properties. However, the biocompatibility of this sealer remains a subject of debate, as some studies raise concerns about potential inflammatory responses or cytotoxic effects associated with resin-based sealers.
Recent advancements have introduced bioceramic-based sealer composed of zirconium oxide, calcium silicates, calcium phosphates, and calcium hydroxide. This sealer is available in pre-mixed syringes for easy application and exhibit hydrophilic properties, allowing for setting reactions in a moist environment within the root canal, thus preventing shrinkage. Moreover, bioceramic-based sealers exhibit favorable biocompatibility due to their similarity to dentin and ability to stimulate mineralization.
NeoSealer Flo (NeoFlo, NuSmile, Houston, TX, USA) is a ready-to-use bioceramic root canal sealer. According to the manufacturer, it has hydroxyapatite formation ability, biocompatibility, dimensional stability, and antimicrobial activity. NeoFlo has adequate physicochemical properties and releases biologically active ions, such as calcium and phosphate. The addition of cetrimide to NeoSealer Flo promoted a greater inflammatory reaction, but the reduction of inflammatory cells and rearrangement of connective tissue suggests that NeoSealer Flo and the associations with cetrimide are biocompatible and have bioactive potential.
Endodontic treatment comprises the overall management of pre-, intra- and post-operative symptoms, including post-operative endodontic pain, considered as a complication susceptible to chronicization. Post-operative pain is very common and highly unpreventable and has a multifactorial etiology and a potential pathogenic link to the acute inflammation of the periapical area, secondary to localized chemical, mechanical, host and/or microbial damage occurring during endodontic treatment.
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:Allaa Mohamed Kamel Mohamed, MSC
- 電話番号:+201006767773
- メール:allaa91mk@gmail.com
研究連絡先のバックアップ
- 名前:Maged Mohamed Negm, professor
- メール:drmagednegm@gmail.com
研究場所
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Minya、エジプト
- 募集
- Minia University, Faculty of Dentistry
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コンタクト:
- Ahmed Ali Yossef, Lecturer
- 電話番号:+201007335293
- メール:ahmed.yousef@mu.edu.eg
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients with mature permanent teeth.
- Patients with apical periodontitis.
- Maxillary anterior teeth only will be involved.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow-up period.
- The selected teeth should have periapical lesion score ≤3
Exclusion Criteria:
- Patients with immature canals.
- Patients with swelling.
- Pregnant females.
- Patients who could/would not participate in a 1-year follow-up.
- Geriatric patients.
- Patients with old age.
- Teeth with periodontal involvement.
- Teeth with vertical root fractures.
- Non-restorable teeth.
- cases with previously initiated endodontic treatment.
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 |
|---|---|
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アクティブコンパレータ:AH plus sealer
About 15 cases will undergo the AH plus sealer during obturation After complete preparation of the root canal system
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to evaluate and compare postoperative pain and periapical healing after root canal treatment using two different base endodontic sealers:
他の名前:
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アクティブコンパレータ:NeoSEALER FLO
About 15 cases will undergo the Neo Sealer FLO during obturation After complete preparation of the root canal system
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to evaluate and compare postoperative pain and periapical healing after root canal treatment using two different base endodontic sealers:
他の名前:
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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 |
|---|---|---|
|
術後の痛みの治療
時間枠:手順の0時間から2週間後
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患者は、痛みの強度を記録するために(NRS)経由で術後の痛みについて評価されます。
フォロー:0読み取りは「痛みなし」を表します。 1-3読み取りは「軽度の痛み」を表します。 4- 6読み取りは「中程度の痛み」を表し、7-10の読みは「激しい痛み」を表します。
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手順の0時間から2週間後
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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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根性癒し
時間枠:6か月から12か月後
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術後の治癒は、術前および術後(6か月および12か月後)の初期病変のサイズを比較し、術後のX線写真とCBCTを使用して評価されます。
これはパーセンテージ(%)で集約されます。
|
6か月から12か月後
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Maged Mohamed Negm, M.D、Professor of Endodontics, Faculty of Dentistry,Cairo University
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
追加の関連 MeSH 用語
その他の研究ID番号
- NeoSEALER FLO & AH plus sealer
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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