Modified 3d Rectangular Grid Plate for Fixation of Anterior and Body Mandibular Fractures
Evaluation of the Use of Modified 3d Rectangular Grid Plate for Fixation of Anterior and Body Mandibular Fractures (Randomized Controlled Clinical Trial)
Background: Fractures of anterior mandible (symphysis and parasymphysis) make up about 9% to 57%, of mandibular fractures, and body fractures make up about 21%; posing challenges for stabilization due to anatomical constraints. Traditional 3D plates have limitations in this area, leading to the development of Modified 3D Rectangular Grid plates. Studies have shown that these plates offer superior stabilization over larger configurations while maintaining a low profile like miniplates. Additionally, design modifications ensure mental nerve preservation, balancing effective fixation with neurovascular safety.
Aim of this study: To evaluate the use of Modified 3D Rectangular Grid plates in comparison with conventional mini plates for fixation of mandibular fracture in the anterior and body regions, clinically regarding pain, interfragmentary mobility, maximal inter-incisal opening, wound healing, and sensory nerve evaluation, and radiographically regrading fracture reduction.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Azarita
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Alexandria、Azarita、エジプト、00203
- Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
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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 suffering from recent fractures at the symphysis, parasymphysis and body regions
- Adult patients with no gender predilection who agreed to present for follow-up visits
- A fracture that demands open reduction and internal fixation.
- The patient medically fit for general anesthesia
Exclusion Criteria:
- Patients suffering from recent fractures at the symphysis, parasymphysis and body regions
- Adult patients with no gender predilection who agreed to present for follow-up visits
- A fracture that demands open reduction and internal fixation
- The patient medically fit for general anesthesia
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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実験的：3D plates
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The system consists of a lower 1.5-mm rectangular plate and an upper linear plate that interlock through circular recesses and elevations.
Each component is 0.75 mm thick at the junction, giving a total thickness of 1.5 mm.
After screw fixation, it provides 3D stability similar to standard 3D plates while minimizing risk to the mental nerve.
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アクティブコンパレータ：Conventional plates
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conventional mini plates for fixation of mandibular fracture in the anterior and body regions
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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 |
|---|---|---|
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change in maximum mouth opening
時間枠：up to 6 weeks
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Using a millimetre ruler to measure maximal inter-incisal mouth opening; considered to be adequate if >30 mm and inadequate if <30 mm
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up to 6 weeks
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change in pain scores
時間枠：up to 6 weeks
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Will be assessed through a 10-point Visual Analogue Scale (VAS).
(0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe
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up to 6 weeks
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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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change in Inter-fragmentary Mobility
時間枠：up to 6 weeks
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The mobility will be assessed by bi-manual palpation across the fracture site.
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up to 6 weeks
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change in Wound Evaluation
時間枠：up to 6 weeks
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The sutured wounds will be examined for signs and symptoms of infection uisng modified Landry's index
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up to 6 weeks
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adequacy of fracture line reduction
時間枠：6 weeks
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Whenever alignment of the inferior border of the mandible will be maintained across the fracture line, it will be considered an excellent reduction.
If a discrepancy of 1-3 mm will be noted, it will be considered a good reduction.
If a discrepancy of 3-5 mm will be noted, it will be labeled as a fair reduction.
If the discrepancy will be > 5 mm, it will be considered a poor reduction.
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6 weeks
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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 (実際)
一次修了 (実際)
研究の完了 (実際)
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
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。