Tooth-borne Interdental Distraction Osteogenesis Along Arch Curvature for Wide Alveolar Clefts Reduction (IDO)
A New Device for Interdental Distraction Osteogenesis for Management of Wide Alveolar Clefts
調査の概要
状態
詳細な説明
Along the journey of treatment of cleft patients, secondary autogenous alveolar bone grafting is the technique basically used for cleft alveolus and palate repair during mixed dentition stage, in order to create bone support for teeth adjacent to the cleft, making a bone matrix through which teeth in the line of the cleft can erupt, re-stabilize alveolar process contour and maxillary segments. In cases with wide alveolar clefts, more than the width of a maxillary canine, failure of this procedure is usually encountered. So, a further step prior to grafting procedure can be done in an attempt to reduce cleft width to enhance success of future grafting.
Distraction osteogenesis (DO) which is a procedure of growing new bone by mechanical stretching of the ordinary pre-existing vascularized bone tissue by a distraction device, where both segments of new alveolar bone as well as attached gingiva are formed can be used here to aid in minimizing cleft width.
The aim of this study was to introduce a new custom-made tooth-borne distractor that could provide 3D control upon using interdental distraction osteogenesis (IDO) with a posterior segment transport anteriorly along curvature of the arch through creating a controlled fracture, then applying this distractor device carrying a bone transport segment forward, decreasing the cleft width anteriorly with another benefit of leaving behind regenerated bone and attached gingiva posteriorly.
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
-
-
-
Cairo、エジプト、11566
- Department of Orthodontics, Faculty of Dentistry, Ain Shams University Cairo, Abbaseya, Egypt
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients with ages ranging from 12 to 25 years old
- Patients with repaired cleft lip and / or palate.
- Patients with wide alveolar clefts more than 6 mm.
- Patients with median facial clefts, absent premaxilla.
- Patients who had previous failed grafting.
Exclusion Criteria:
- Patients with contraindications to general anaesthesia and surgery.
- Patients with syndromic cleft lip and palate.
- Patients with very bad oral hygiene.
- Vulnerable groups.
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Tooth borne interdental distraction along arch curvature appliance
Patients eligible to the study were prepared to receive interdental distraction osteogenesis.
The appliance was custom made for each patient.
It is made up of orthodontic bands, labial, palatal stainless steel 0.9mm arches and micro expander screw soldered to the first permanent molar and to the first premolar in the transport segment .
|
This study aimed to provide a new design of a tooth-borne, custom-made distractor that could be easily constructed and rigid enough for controlled segment transport. After cases' selection, arch expansion was done first. Following expansion, preparation of the osteotomy site was done, through inducing root divergence at site of interdental osteotomy. Osteotomies were performed under general anesthesia using piezo-surgery, there were 2 osteotomies in a L-shape; interdental vertical osteotomy mesial to 1st molar and a horizontal one above apices of teeth in the transport segment. The distraction protocol was a latency period of 7 days, after which appliance activation started with a distraction rate of 0.4 mm/day with a rhythm of twice daily. Activation proceeded till teeth at the edge of the cleft came into contact. Then the appliance was fixed in place for a 3 months consolidation period.
他の名前：
|
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 |
|---|---|---|
|
Reduction of width of alveolar cleft and oronasal fistula
時間枠：2-3 months
|
Reduction or even closure of the wide interdental alveolar defect and the oronasal fistula measured on CBCT radiograph
|
2-3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Dental changes with distraction
時間枠：2-3 months
|
Amount of dental tipping that occurred with distraction forces measured on CBCT radiograph
|
2-3 months
|
|
Quality of distracted bone
時間枠：3-6 months
|
Measurement of bone radio density in Hounsfield Unit from CBCT
|
3-6 months
|
|
Loss of anchorage with distraction forces
時間枠：2-3 months
|
Amount of distal movement of anchor molar of the assembly as a side effect of the mesial distraction forces measured on CBCT radiograph
|
2-3 months
|
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
本研究に関する用語
その他の研究ID番号
- FDASU-RecM121715
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?
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。