3D Printed Reverse Twin Block for Class III Malocclusion (3DRTB)
Effectiveness of a Novel 3D Printed Reverse Twin Block in The Management of Maxillary Deficiency of Class III Malocclusion: A Randomized Clinical Trial
This RCT aims to evaluate the effectiveness of a novel 3D printed reverse twin block appliance in the management of maxillary deficiency in growing patients having class III malocclusion. The clinical outcomes of this appliance will be compared with the conventional reverse twin block appliance over 6 months treatment period.
primary objective is evaluating of the effectiveness of 3DRTB in correcting sagittal discrepancies due to maxillary deficiency in class III malocclusion compared to conventional one while secondary objectives are assessment of transverse and vertical jaw relationship produced by 3DRTB compared to CRTB and to evaluate the soft tissue profile of class III patients and to evaluate the maxillary and mandibular incisor inclination, also assessment of patient perception with both appliances by using questionnaire and finally to assess the impact of 3DRTB on oral health compared to CRTB by using oral hygiene index.
調査の概要
状態
条件
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：Linda Basim, PhD
- 電話番号：+9647812867005
- メール：landa.hadi2403@codental.uobaghdad.edu.iq
研究場所
-
-
-
Baghdad、イラク
- 募集
- Collage of Dentistry, University of Baghdad
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- The age group selected is mixed dentition group 8-13 years with residual potential maxillary growth. Patient maturity will be assessed using the Cervical Vertebral Maturation (CVM) method on lateral cephalogram, patients in CS1-CS3 stages will be included to ensure remaining maxillary growth.
- Presence of permanent first molar with lower anterior teeth to retain the appliance.
Skeletal/dental class III tendency with anterior cross bite or reverse overjet: a. Clinically the overjet is equal or less than zero up to -3 mm.
b. Cephalometric ANB angle equal or less than zero up to -3 degrees and Wits appraisal ≤ -2.
- Prescence of unilateral or bilateral posterior crossbite.
- Mild to moderate anterior crowding.
- Acceptable oral hygiene baseline defined by oral hygiene index (OHI). -
Exclusion Criteria:
- Patients with cleft lip and palate and/or craniofacial anomalies.
- History of previous orthopedic and/or orthodontic treatment.
- Presence of uncontrolled systemic disease or medically compromised status.
- Uncooperative patient/parents.
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 |
|---|---|
|
実験的：3D printed Reverse Twin Block appliance
patients with class III malocclusion will receive a novel 3D printed reverse twin block with expansion screw for expansion and protraction of maxilla and will be digitally designed using CAD software and fabricated using photopolymer resin.
|
a CAD-CAM novel reverse twin block appliance will be used for orthopedic management of maxillary deficiency in growing patients with class III malocclusion.
|
|
アクティブコンパレータ：Conventional Reverse Twin Block appliance
patients with class III malocclusion will receive a conventional reverse twin block with expansion screw for expansion and protraction of maxilla and will be fabricated from acrylic resin.
|
a conventionally fabricated Reverse Twin Block appliance will be used for correction of maxillary deficiency in growing patients with class III malocclusion
|
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 |
|---|---|---|
|
Changes in sagittal relation using lateral cephalometric radiograph.
時間枠：T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment
|
By using cephalometric radiograph skeletal changes in sagittal plane will be measured like: 1. SNA angle in degrees.
2. SNB angle in degrees.
3. ANB angle in degrees.
4. Wits appraisal in degrees. 5. SN-Pog angle
|
T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Transverse relationship by Study model
時間枠：T0 baseline records T1 after 3 months T2 after 6 months
|
This will measure by scanned digital study model to calculate the amount of expansion at T0, T1, T2.
|
T0 baseline records T1 after 3 months T2 after 6 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Oral hygiene index-children (OHI-C) will be measured
時間枠：T0 baseline record T1 after 3 months T2 after 6 months
|
The six index teeth that will be included:
|
T0 baseline record T1 after 3 months T2 after 6 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 (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
追加の関連 MeSH 用語
その他の研究ID番号
- 1213426
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。