Clinical Evaluation of Conventional and 3D-printed Implant-supported Overdentures Retained With New Attachment Systems (IODs)
2026年5月7日 更新者：Mohamed Moustafa、Al-Azhar University
Randomized Crossover Clinical Trial Comparing Two Denture Designs (A and B) Retained by Two Locator Systems (ST and EMI) in Implant Overdenture Patients
調査の概要
詳細な説明
This randomized crossover clinical trial evaluates patient-reported outcomes and clinical performance of implant overdentures (IODs) using two different denture designs (A and B) retained by two locator attachment systems: Locator ST and Locator EMI.
Each participant will receive both denture designs in a crossover sequence, allowing direct within-subject comparison.
研究の種類
介入
入学 (推定)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Asyut、エジプト
- Faculty of Dental Medicine, Al-Azhar University, (Assiut Branch)
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Completely edentulous patients
- Non-smokers
- Patients free from intra-oral diseases that may affect implant-overdenture prognosis
- Patients free from systemic conditions that may influence bone resorption or implant success
- Able and willing to comply with study visits and follow-up schedule
Exclusion Criteria:
- Smokers or tobacco users
- Presence of active oral lesions, infections, or mucosal pathology
- Systemic diseases affecting bone metabolism (e.g., uncontrolled diabetes, osteoporosis requiring bisphosphonates)
- History of head and neck radiation
- Severe parafunctional habits (e.g., bruxism)
- Inability to attend follow-up appointments or provide informed consent
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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 |
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実験的：Arm 1: Denture A with Locator ST Participants receive Denture A retained by Locator ST attachments.
Participants receive Denture A retained by Locator ST attachments.
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Participants receive Denture A, a conventional mandibular implant overdenture, retained by two Locator ST attachments placed in the interforaminal region.
Outcomes include OHIP-19, VAS satisfaction, retention force, attachment wear, periodontal parameters, and denture tooth wear resistance.
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実験的：Denture A with Locator EMI
Participants receive Denture A retained by two Locator EMI attachments.
Same outcome measures as above, allowing comparison of attachment type influence on patient-reported and clinical outcomes.
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Participants receive Denture A, a conventional mandibular implant overdenture, retained by two Locator ST attachments placed in the interforaminal region.
Outcomes include OHIP-19, VAS satisfaction, retention force, attachment wear, periodontal parameters, and denture tooth wear resistance.
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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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Retention Force of Implant Overdentures (IODs)
時間枠：Outcome measures were assessed at four clearly defined time points: 1. Baseline (Immediately after overdenture pick up) 2. 3 month follow up 3. 6 month follow up 4. 9 month follow up These time points correspond to the evaluation of implant overdentures
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Retention force measured using a digital force gauge to quantify the dislodgement force required to remove the overdenture from the implants.
Measurements will be reported in Newtons (N).
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Outcome measures were assessed at four clearly defined time points: 1. Baseline (Immediately after overdenture pick up) 2. 3 month follow up 3. 6 month follow up 4. 9 month follow up These time points correspond to the evaluation of implant overdentures
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Denture Wear of Implant Overdentures (IODs)
時間枠：Wear was evaluated relative to the baseline measurement taken immediately after pick-up, with follow-up assessment 9-month per denture type: 1. 3 month follow up 2. 6 month follow up 3. 9 month follow up
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Denture wear assessed by measuring surface loss on occlusal surface using digital analysis.
Wear depth recorded in millimeters (mm) at each evaluation point.
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Wear was evaluated relative to the baseline measurement taken immediately after pick-up, with follow-up assessment 9-month per denture type: 1. 3 month follow up 2. 6 month follow up 3. 9 month follow up
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Peri-implant Soft Tissue Health (Modified Plaque Index and Modified Bleeding Index Scores)
時間枠：Assessments performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months
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Peri-implant soft tissue health assessed using the Modified Plaque Index (mPI) and Modified Bleeding Index (mBI). Both indices are ordinal clinical scales scored according to standard peri-implant evaluation criteria: mPI range: 0-3 0 = no plaque 3 = abundant plaque mBI range: 0-3 0 = no bleeding 3 = profuse bleeding Interpretation: Higher scores indicate worse peri-implant soft tissue health. Unit of Measure: Ordinal index scores (mPI, mBI) |
Assessments performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months
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Crestal bone level changes
時間枠：Radiographic measurements performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months
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Crestal bone levels measured on standardized periapical radiographs taken with a paralleling technique.
Bone level is defined as the distance from the implant shoulder to the first bone-to-implant contact.
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Radiographic measurements performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months
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Oral Health-Related Quality of Life (OHIP-19 score)
時間枠：OHIP-19 scores recorded three times during each 9-month denture phase: 1 -Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up
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Oral health-related quality of life assessed using the Oral Health Impact Profile-19 (OHIP-19) questionnaire. The OHIP-19 consists of 19 items, each scored on a 5-point ordinal scale from 0 to 4: 0 = never 4 = very often Minimum score: 0 Maximum score: 76 Interpretation: Higher scores indicate worse oral health-related quality of life. |
OHIP-19 scores recorded three times during each 9-month denture phase: 1 -Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up
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Patient Satisfaction (Visual Analog Scale Score)
時間枠：VAS satisfaction scores recorded three times during each 9-month denture phase: 1 - Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up
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Patient satisfaction with the denture and attachment system measured using a 10-point Visual Analog Scale (VAS). Participants rated their satisfaction on a scale from 0 to 10: 0 = completely dissatisfied 10 = completely satisfied |
VAS satisfaction scores recorded three times during each 9-month denture phase: 1 - Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年6月1日
一次修了 (推定)
2026年6月1日
研究の完了 (推定)
2026年8月1日
試験登録日
最初に提出
2026年4月25日
QC基準を満たした最初の提出物
2026年5月7日
最初の投稿 (実際)
2026年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月12日
QC基準を満たした最後の更新が送信されました
2026年5月7日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- Al-Azhar University, (Assiut B
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
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