Comparing Obturation Using Bioceramic Nano-coated Gutta-percha With Bioceramic Sealer Versus Traditional Gutta-percha With Resin Sealer for Reducing Postoperative Pain and Swelling After Root Canal Treatment in Necrotic Single-rooted Teeth.
Comparative Evaluation of Obturation Using Bioceramic Nano-coated Gutta-percha and Bioceramic-based Sealer Versus Gutta-percha and Resin-based Sealer on Postoperative Pain and Swelling: A Randomized Clinical Trial.
A randomized clinical trial will compare two root canal filling approaches in necrotic single-rooted teeth. The test group will receive bioceramic mono-block obturation using bioceramic nano-coated gutta-percha with a bioceramic sealer, while the control group will receive traditional gutta-percha with a resin-based sealer. The main aim is to determine whether the bioceramic system can reduce postoperative pain and swelling within 48 hours after treatment compared with the conventional method. Patients aged 20-55 years who have necrotic single-rooted teeth and meet specific clinical and radiographic criteria will be recruited from the outpatient clinics of the Faculty of Dentistry, Cairo University.
Postoperative pain will be measured using a visual analogue scale, and swelling will be assessed using a standardized swelling score at 24 and 48 hours. The study hypothesizes that the bioceramic mono-block technique, due to its improved sealing ability and bioactivity, may lead to less postoperative discomfort and better early clinical outcomes than the gold-standard resin-sealer technique. The findings are expected to provide evidence to guide clinicians on whether adopting bioceramic nano-enhanced obturation can improve patient-centered outcomes after root canal treatment.
調査の概要
状態
詳細な説明
This randomized clinical study aims to compare the clinical and radiographic outcomes of root canal obturation using a bioceramic sealer with bioceramic-coated gutta-percha versus conventional obturation using a resin-based sealer with conventional gutta-percha. The study will be conducted on patients requiring endodontic treatment according to the established inclusion and exclusion criteria.
Participants will be randomly allocated into two groups. The control group will receive obturation using conventional gutta-percha with a resin-based sealer, while the experimental group will receive obturation using bioceramic-coated gutta-percha with a bioceramic sealer. Standardized endodontic treatment procedures will be performed for all participants.
Clinical and radiographic evaluations will be carried out during the follow-up period to assess treatment success, postoperative pain, postoperative swelling, and obturation quality. The outcomes of this study may help determine the effectiveness and clinical performance of bioceramic obturation materials compared with conventional obturation techniques in endodontic therapy.
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：Hussein M Taha
- 電話番号：+201004421891
- メール：hussein.mohamed@dentistry.cu.edu.eg
研究場所
-
-
Cairo Governorate
-
Cairo、Cairo Governorate、エジプト
- Out patient clinic Faculty of Dentistry Cairo University
-
-
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 aged 20-55 years. Patients with good oral hygiene, free of calculus, and with a probing depth not exceeding 2-3 mm.
Necrotic single-rooted, single-canal permanent teeth with or without periapical lesions. If lesion is present, ranging from 2-5 mm in size.
Absence of swelling. Medically free patients.
Exclusion Criteria:
Patients with poor oral hygiene. Vital teeth. Necrotic teeth without periapical lesions. Primary teeth. Complex root morphology other than Type I. Internal or external root resorption. Vertical root fractures. Cracked teeth. Intraoral or extraoral swelling.
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：トリプル
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：Conventional obturation group.
Root canal obturation using resin-based sealer with conventional gutta-percha.
|
It is the gold standard obturation technique which will be used as the control group.
|
|
実験的：Bioceramic obturation group.
Root canal obturation using bioceramic sealer with bioceramic coated gutta-percha.
|
Bioceramic sealer and bioceramic gutta-percha creating a monoblock for obturation of root canals.
|
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 |
|---|---|---|
|
Postoperative pain assessed by using a 10 cm Visual Analogue Scale.
時間枠：48 hours
|
Pain will be assessed using a 10 cm Visual analogue Scale from 0-10, where 0 indicates no pain, 1-3 Mild pain, 4-6 Moderate Pain and 7-10 Sever pain. Participants will be asked to verbally report their pain score after 24 hours and 48 hours. |
48 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative swelling assessed by using a 4 point Numerical Rating Scale.
時間枠：48 hours
|
Postoperative swelling will be assessed using a Numerical Rating scale. Assessment will be evaluated using a 4 point Numerical Rating Scale ranging from 0-3, where 0 indicates no swelling, 1 indicates mild intra oral swelling, 2 indicates moderate extra oral swelling, and 3 indicates sever swelling including more than one facial structure. The investigator will asses swelling at 24 hours and 48 hours. |
48 hours
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Ghada Ehab ElWazzan, Lecturer、Cairo university
- スタディディレクター：Alaa ElBaz, Professor、Cairo university
出版物と役立つリンク
一般刊行物
- Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.
- Fonseca B, Coelho MS, Bueno CEDS, Fontana CE, Martin AS, Rocha DGP. Assessment of Extrusion and Postoperative Pain of a Bioceramic and Resin-Based Root Canal Sealer. Eur J Dent. 2019 Jul;13(3):343-348. doi: 10.1055/s-0039-3399457. Epub 2019 Dec 3.
- Zamparini F, Lenzi J, Duncan HF, Spinelli A, Gandolfi MG, Prati C. The efficacy of premixed bioceramic sealers versus standard sealers on root canal treatment outcome, extrusion rate and post-obturation pain: A systematic review and meta-analysis. Int Endod J. 2024 Aug;57(8):1021-1042. doi: 10.1111/iej.14069. Epub 2024 Apr 12.
- Pirani C, Camilleri J. Effectiveness of root canal filling materials and techniques for treatment of apical periodontitis: A systematic review. Int Endod J. 2023 Oct;56 Suppl 3:436-454. doi: 10.1111/iej.13787. Epub 2022 Jul 5.
- Alghamdi A, Mominkhan D, Sabano R, Alqadi NF, Al-Habib M, Bukhari S, Howait M, Alsofi L. Factors Associated with Postsurgical Pain and Swelling Following Endodontic Microsurgery: The Role of Radiographic Characteristics. Healthcare (Basel). 2025 Apr 25;13(9):995. doi: 10.3390/healthcare13090995.
- Swetha B, Priya BD, Reddy KH, Prasanthi G, Mohan TM, Tejaswi D. Comparative evaluation of bioactive calcium silicate coating on functionalized gutta-percha and its effect on bioceramic sealer wettability - An in vitro study. J Conserv Dent Endod. 2025 Jul;28(7):613-618. doi: 10.4103/JCDE.JCDE_159_25. Epub 2025 Jul 2.
- Somolová L et al. Comparison of apical microleakage in bioceramic and resin-based sealers with conventional and bioceramic surface-impregnated gutta-percha points. Ceramics. 2025.
- Rao MH, Krishnan R, Kumaraswamy M, Keshav A, Gopal P, Thomas E. Assessment of Treatment Outcomes with Complete Orthograde Obturation with Bioceramic Materials: A Scoping Review. J Contemp Dent Pract. 2024 Dec 1;25(12):1190-1197. doi: 10.5005/jp-journals-10024-3764.
- Elmsmari F, Elsayed Y, Aboubakr A, Kaafarani M, Nour O, Pawar AM. Clinical and radiographic success of single-cone bioceramic obturation versus traditional techniques: a systematic review and meta-analysis of randomized controlled trials. J Oral Biol Craniofac Res. 2025 Nov-Dec;15(6):1422-1432. doi: 10.1016/j.jobcr.2025.08.031. Epub 2025 Sep 2.
- Abou-Elnaga MY, Refai AS, Alkhawas MA. Post operative pain and swelling evaluation following guided endodontic microsurgeries done using different treatment modalities: a clinical study.
研究記録日
主要日程の研究
研究開始 (推定)
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
その他の研究ID番号
- CU-HT-Protocol
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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
米国で製造され、米国から輸出された製品。
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。
歯の痛みの臨床試験
-
Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
-
Dexa Medica Group完了