the Objective of This Research is to Compare the Clinical Effectiveness of the Conventional Lingual Arch Space Maintainers With Three-dimensional Printed Space Maintainers.
Comparative Evaluation of the Conventional and Three-Dimensional Printed Lower Lingual Arch Space Maintainers A Randomized Clinical Trial
調査の概要
状態
条件
詳細な説明
Introduction and Review of literature Primary teeth serve to preserve inborn space until permanent teeth erupt, in addition they help with speech and mastication. It is appropriate to highlight the primary dentition's function as the best space maintainer for permanent teeth. It is possible that premature primary tooth loss will cause undesirable primary and permanent tooth movements, including a loss in arch length. If there is not enough arch length, it is more likely to predict malocclusions such as crowding and ectopic eruption as well as tooth impaction.
Since the largest space loss occurs within a month of losing the deciduous teeth, it is best to use a space maintainer as soon as possible after early tooth loss. Space maintainers are the orthodontic appliance of choice for preventing space loss because they preserve space within the oral cavity.
Conventional space maintainers have significant drawbacks despite their clinical effectiveness. These include the need for patient compliance, extended chairside times, multiple steps in the fabrication process, technique-sensitive impressions and lab procedures, solder failure, and caries formation at band margins.
These disadvantages in the conventional space maintainer recommend the need for more advanced appliance designs and materials, one of which is three-dimensional (3D) printing, The process involves creating 3D objects using a digitally scanned and layered design of the entire object. The design is preserved using a "Standard Tessellation Language" (STL) file.
So, the objective of this research is to compare the clinical effectiveness of the conventional lingual arch space maintainers with three-dimensional printed space maintainers.
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：Reham M. Assistant Professor, PhD
- 電話番号：+966545318171
- メール：reham_mohamed@dent.suez.edu.eg
研究連絡先のバックアップ
- 名前：Rim M. Lecturer, PhD
- 電話番号：+201222726567
- メール：rim_fathalla@dent.suez.edu.eg
研究場所
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Ismailia Governorate
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Ismailia、Ismailia Governorate、エジプト、41522
- 募集
- Suez Canal University
-
コンタクト：
- Reham M. Principle investigator, Assistant professor
- 電話番号：0545318171
- メール：reham_mohamed@dent.suez.edu.eg
-
コンタクト：
- Rim M. Co-investigator, Lecturer
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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:
- Apparently, healthy cooperative children have recently prematurely loss of more than one mandibular primary molar in any of the quadrants, full erupted mandibular first permanent molars in both sides, and whose lower permanent incisors have erupted
- The permanent successors of the lost primary molars were not expected to erupt within 6 months
- Angle's class 1 occlusion with normal primary molar relation
- Caries-free and periodontally healthy abutment teeth
- Absence of parafunctional habits or abnormal occlusion conditions such as crossbite, open bite, or deep bite.
- Children's age ranges from 7 to 9 years-old
- Radiographically, presence of permanent successors, more than one millimeter of bone covering the successor tooth germ, and/or only about one-third of the root of the permanent tooth has been formed.
- Parents and children were accepting the new treatment modality.
Exclusion Criteria:
- children exhibited poor oral hygiene, para-functional oral habits, severe crowding, space loss, and abnormal occlusion
- Extraction of primary molars exceeding three months.
- Radiographically, absence of permanent successor.
- uncooperative children
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：Group I
Conventional spacemaintainer
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Two bands will be selected and checked for fit and adaptation around the distal abutment teeth, then an alginate impression will be taken and will be sent to the laboratory for fabrication
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実験的：Group II
3D printed spacemaintainer
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An intraoral scan for the patients' lower arch will be taken using a 3D digital dental scanner.
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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 |
|---|---|---|
|
Patient satisfaction and pain experienced using the Wong-Baker Faces Test
時間枠：9 months
|
Patient satisfaction and pain experienced during conventional and digital impression and cementation will be evaluated using the Wong-Baker Faces test and subsequently recorded for clinical satisfaction at 3 months, 6 months and 9 months for both patient groups to evaluate appliance acceptance and convenience for the patients.
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9 months
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Gingival health will be evaluated using Sillness and Loe Gingival Index
時間枠：9 months
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gingival health will be evaluated by Sillness and Loe Gingival Index Evaluation of the gingival health according to the (GI) described by (Loe and Silness, 1963): Score Criteria for the Gingival Index 0 No inflammation.
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9 months
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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 |
|---|---|---|
|
Impression taking experience for the patient assessed by 6-questions survey
時間枠：Day 1
|
Questions Answer by Yes (√) or (No) ×
|
Day 1
|
協力者と研究者
スポンサー
出版物と役立つリンク
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
その他の研究ID番号
- 930/2024
- Organization's Unique Protocol (930/2024)
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
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
米国で製造され、米国から輸出された製品。
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