Chewing Pattern Changes Before and After Space Maintainer Placement in Children
Evaluation of Changes in Chewing Pattern in Children Before and After Space Maintainer Placement
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：afra savas
- 電話番号：90 5343279274
- メール：aafranursavas@gmail.com
研究場所
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Maltepe
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Istanbul、Maltepe、トルコ（Türkiye）
- Marmara University
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コンタクト：
- savas
- 電話番号：90 5343279274
- メール：aafranursavas@gmail.com
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Children aged 6-10 years. Premature loss or extraction of a primary molar in the maxilla or mandible with a clinical indication for a unilateral fixed band-and-loop space maintainer.
The abutment tooth for the space maintainer is vital and either sound or appropriately restored.
Complete dentition on the contralateral side of the arch to allow reliable assessment of chewing function.
No systemic condition affecting chewing function. Written informed consent provided by a parent or legal guardian; children aged 9 years and older also provide written assent.
Exclusion Criteria:Severe developmental delay, severe behavioral problems, or neuromuscular disorders that may directly affect chewing function, muscle activity, or treatment cooperation.
Temporomandibular joint disorder. Current orthodontic treatment. Anterior or posterior crossbite, open bite, or other skeletal/dental malocclusions that may affect chewing function.
Additional missing teeth in the contralateral arch, including hypodontia. Craniofacial anomalies, including cleft lip/palate syndromes. Systemic conditions requiring special medical precautions or antibiotic prophylaxis during routine dental treatment. -
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
コホートと介入
グループ/コホート |
介入・治療 |
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Children Receiving a Unilateral Band-and-Loop Space Maintainer
Children aged 6-10 years with premature loss of a primary molar and a clinical indication for a unilateral fixed band-and-loop space maintainer.
Chewing pattern and chewing performance will be assessed before space maintainer placement and again four weeks after placement.
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A unilateral fixed band-and-loop space maintainer will be placed as part of routine clinical care following premature loss of a primary molar.
The appliance will be cemented to the abutment tooth with glass ionomer cement, and occlusion will be checked after placement.
The space maintainer is not assigned for research purposes; it is clinically indicated before study enrollment.
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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 Masticatory Performance
時間枠：Baseline and 4 weeks after space maintainer placement
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Change in masticatory performance from before space maintainer placement to 4 weeks after placement, assessed using a two-color chewing gum test.
After 20 chewing cycles, color mixing will be scored using the Orophys Subjective Assessment Scale from SA1 to SA5, with higher scores indicating more complete color mixing and better masticatory performance.
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Baseline and 4 weeks after space maintainer placement
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Change in Chewing Pattern
時間枠：Baseline and 4 weeks after space maintainer placement
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Change in chewing pattern from before space maintainer placement to 4 weeks after placement.
The dominant chewing side (right/left) will be observed during seven standardized chewing trials.
Children using the same side in at least four of seven trials will be classified as unilateral chewers; those showing side alternation will be classified as bilateral chewers.
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Baseline and 4 weeks after space maintainer placement
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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 (推定)
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
- chewing.p
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。