Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures
Comparison of Open Mouth Vs Closed Mouth Edentulous Impression Technique: A Hospital Based Study
This randomized controlled trial compares two final impression techniques for complete dentures, the open mouth technique and the closed mouth technique. Completely edentulous adults with well-formed ridges will be randomly assigned 1:1 to one of the two techniques. All dentures will be made by a single operator using the same materials and laboratory. Six weeks after insertion, an examiner blinded to group allocation will assess denture retention using the Kapur index, and patient satisfaction will be recorded using a 5-item Likert questionnaire.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
In the open mouth group, border molding and the wash impression are made with the patient's mouth open and no occlusal contact. In the closed mouth group, occlusal rims are attached to the custom trays at a predetermined occlusal vertical dimension, and the impression is made while the patient closes and performs functional movements. Jaw relations, try-in, and insertion follow the same protocol for both groups. Retention is scored separately for the maxillary and mandibular dentures, with a score of 2 or 3 counted as adequate. Satisfaction scores range from 5 to 25, and a score of 16 or above counts as satisfied.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Fatima Shakeel, BDS
- 電話番号：+92 335 8416673
- メール：fatimasmir25@gmail.com
研究場所
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Punjab Province
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Rawalpindi、Punjab Province、パキスタン、46000
- Department of Prosthodontics, Watim Medical and Dental College, Rawat, Rawalpindi, Punjab, Pakistan
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コンタクト：
- Fatima Shakeel, BDS
- 電話番号：+92 335 8416673
- メール：fatimasmir25@gmail.com
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults aged 18 to 70 years
- Completely edentulous in both maxilla and mandible for at least six months, confirmed by clinical examination and orthopantomogram
- Well-formed ridges, ACP classification Class I or Class II
Exclusion Criteria:
- Flabby or hypermobile ridges
- Atrophic ridges
- Ridges with bony exostosis
- Active oral pathology
- History of radiotherapy to head and neck
- Uncontrolled systemic disease
- Neuromuscular or neurological disorders
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
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ：Group A: Open Mouth Technique
Final impressions made in custom trays with sectional border molding using low fusing impression compound and a zinc oxide eugenol wash, with the mouth open and no occlusal contact. |
Secondary impression of the edentulous arch made in a custom acrylic tray. Border molding is done in sections with low fusing impression compound, followed by a zinc oxide eugenol wash impression. The clinician manipulates the tissues and the patient performs functional movements, with the mouth open and no occlusal contact. All steps are done by a single trained operator using the same materials and laboratory as the comparison group.
他の名前：
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アクティブコンパレータ：Group B: Closed Mouth Technique
Final impressions made in custom trays with attached occlusal rims set to a predetermined vertical dimension. Border molding and the wash impression are made while the patient closes into occlusion and performs functional movements. |
Secondary impression made in custom trays with occlusal rims attached and adjusted to a predetermined occlusal vertical dimension. Maxillary and mandibular trays are inserted together. Border molding with low fusing impression compound and a zinc oxide eugenol wash impression are made while the patient closes into occlusion and performs functional movements, recording the denture bearing areas under simulated functional load. All steps are done by a single trained operator using the same materials and laboratory as the comparison group.
他の名前：
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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
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adequate retention of maxillary denture
時間枠：6 weeks after denture insertion
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Kapur index score (0 nil, 1 poor, 2 fair, 3 good) assessed by a blinded examiner. A score of 2 or 3 is adequate and 0 or 1 is inadequate. |
6 weeks after denture insertion
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adequate retention of mandibular denture
時間枠：6 weeks after denture insertion
|
Kapur index score assessed the same way as the maxillary denture. |
6 weeks after denture insertion
|
|
Patient satisfaction
時間枠：6 weeks after denture insertion
|
5-item Likert questionnaire covering retention, comfort, mastication, phonetics, and overall satisfaction, with a total score of 5 to 25. A score of 16 or above counts as satisfied. |
6 weeks after denture insertion
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Fatima Shakeel, BDS、Watim Medical and Dental College
- スタディディレクター：Zarah Afreen, BDS, FCPS、Watim Medical and Dental College
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- WMDC/R&D(ERB)/2025/241
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
Individual participant data will not be shared publicly to protect participant confidentiality. Summary results will be published in a peer-reviewed journal.
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
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