Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition
2026年8月10日 更新者：Wroclaw Medical University
Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition. Randomised Control Study
Evidence for the undeniable role of microscrews in anchorage control, as well as their other advantages, such as ease of insertion and removal techniques, have led to their routine use in orthodontics.
Treatment with microscrews, despite its obvious advantages, is associated with the risk of complications, the etiology of which is multifactorial.
Identifying (and subsequently controlling) as many of them as possible through research constitutes an ongoing challenge for scientists.
This pursuit defined the purpose of the present study: to determine whether a type of TISAD insertion technique - self-drilling or self-tapping - as well as the patient's sex and maxillary quadrant constitute predisposing factors for the occurrence of certain complications.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
1008
段階
- 適用できない
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
- 大人
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Patients between 20 and 40 y.o. with indication for microimplant insertion in the maxilla to reinforce anchorage during en bloc distalisation.
Exclusion Criteria:
- Smoking,
- Inadequate oral hygiene
- Chronic diseases (e.g. diabetes)
- Tooth loss
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Insertion with self-drilling technique
Each patient received two microimplants both using self- drilling method.
In accordance with the principles of a randomized controlled trial, the choice between the self-drilling and self-tapping techniques was alternated between patients by a flip of a coin performed by a dental assistant.
|
Patients received 2 miniscrews using self-drilling method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated complications were:
|
|
実験的：Insertion with self-tapping technique
Each patient received two microimplants both using self-tapping method.
In accordance with the principles of a randomized controlled trial, the choice between the self-drilling and self-tapping techniques was alternated between patients by a flip of a coin performed by a dental assistant.
|
Patients received 2 miniscrews using self-tapping method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated factors were:
|
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 |
|---|---|---|
|
Assessing the presence of peri-implantitis
時間枠：The occurrence of inflammation was recorded during subsequent follow-up visits (first 2 weeks after implantation and then every 6 weeks, until the distalization was completed, assessed up to 12 months).
|
Hypertrophy of the gingiva and/or redness and/or tendency to bleed was noted as the inflammation presence.
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The occurrence of inflammation was recorded during subsequent follow-up visits (first 2 weeks after implantation and then every 6 weeks, until the distalization was completed, assessed up to 12 months).
|
|
Assessing the presence of pain lasting longer than 48 hours after implantation.
時間枠：2 weeks after implantation
|
Two weeks after the miniscrew implantation patients were surveyed upon pain incidence lasting longer than 48 hours.
|
2 weeks after implantation
|
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Assessing the presence of root perforation
時間枠：Immediately after implantation
|
Root perforation was diagnosed in CBCT performed after the procedure.
|
Immediately after implantation
|
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Assesing the presence of microimplant fracture
時間枠：During implantation
|
Microimplant fracture was diagnosed during implantation, reported by the clinician.
|
During implantation
|
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Assessing the stability of miniscrews
時間枠：During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.
|
The mobility of the miniscrews was checked clinically with cotton tweezers at each visit.
Miniscrews that could not sustain orthodontic force and required replacement because of mobility were considered failures.
|
During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.
|
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。
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)
2015年1月1日
一次修了 (実際)
2024年3月31日
研究の完了 (実際)
2024年5月14日
試験登録日
最初に提出
2026年7月21日
QC基準を満たした最初の提出物
2026年8月10日
最初の投稿 (実際)
2026年8月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月12日
QC基準を満たした最後の更新が送信されました
2026年8月10日
最終確認日
2024年6月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- SUBZ.B190.24.005
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?
いいえ
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
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