Impact of Minimally Invasive Endodontic Treatment on the Prognosis of Mandibular Permanent Molars With Necrotic Pulp and Apical Periodontitis
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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Asyut Governorate
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Asyut、Asyut Governorate、エジプト
- Faculty of dentistry, Assiut university
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コンタクト:
- Mohamed Ashraf Abdeen, Msc
- 電話番号:00201006518663
- メール:M.abdeen@dent.aun.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:
- Participants with free medical history (category: American Society of Anaesthesiologists class I) from either gender aged from 20 to 50 years old.
- Necrotic lower first molars with four root canals (two mesials and two distals).
- Teeth have a periapical radiolucency with a diameter of 2-4 mm in CBCT images.
- Teeth show root curvature of 10°-20° as described by Schnider.
- Participant that indicated for single visit root canal treatment.
Exclusion Criteria:
- Calcified or non-negotiatable teeth.
- Participants who cannot apply for the follow-up schedule.
- Teeth that show any signs of cracks or vertical root fractures.
- Teeth that show less than 50% of sound coronal tooth structure.
- Periodontally affected teeth.
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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アクティブコンパレータ:Traditional group
In this group traditional access cavity and canal preparations is done
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Root canal treatment is done
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アクティブコンパレータ:Minimally invasive group
In this group conservative access cavity and minimally invasive root canal preparation is done
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Root canal treatment is done
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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 rate
時間枠:1 year follow up
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A case is deemed successful if there is no clinical signs and symptoms of infection or inflammation and radiographic bone healing. The success rate for each group will be determined by the ratio of successful cases to the total number of cases in that group. |
1 year follow up
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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 |
|---|---|---|
|
Healing of periapical lesion
時間枠:1 year
|
The change in the size of periapical radiolucencies will be assessed through a comparison of CBCT images taken preoperatively and at the 12-month follow-up.
This evaluation will be conducted by two independent operators who are not aware of the treatment group assignments to ensure unbiased results.
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1 year
|
|
Bacterial load
時間枠:Within 2 days after intervention
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The bacterial levels within the root canals will be quantified at two critical stages of the treatment process: S1: Immediately following the creation of the access cavity, prior to initiating any cleaning or shaping procedures. This step is crucial for determining the initial bacterial load present in the root canal system. S2: Following irrigant activation. This measurement will provide insight into the efficacy of the cleaning and shaping procedures, as well as the irrigation protocol, in reducing the bacterial population within the canal. These bacterial samples will be collected using sterile a three size #15 paper points which will be inserted into the canals to absorb the canal contents. This method ensures a standardized approach to bacterial sampling at these specified stages of the treatment. |
Within 2 days after intervention
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Treatment duration
時間枠:During procedure
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The total time taken to complete the treatment procedure, from the beginning of the access cavity preparation to the completion of obturation, will be meticulously recorded for each case.
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During procedure
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Iatrogenic errors
時間枠:During procedure
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Any occurrences of iatrogenic errors, such as instrument separation, will be noted and recorded.
This data will provide insight into the potential risks associated with each treatment approach.
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During procedure
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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 (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
- Minimally invasive endo
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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
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。