Microbial Adhesion and Peri-Implant Tissue Health in All-on-Four Hybrid Prostheses Supported by Zantex or Zirconia Frameworks
Microbial Adhesion and Peri-Implant Tissue Health in All-on-Four Hybrid Prosthesis Supported by Zantex or Zirconia Framework. A Randomized Clinical Trial
調査の概要
詳細な説明
Complete edentulism remains a major clinical challenge, particularly among aging populations. All-on-Four fixed implant-supported prostheses have become a widely used solution, but the long-term success of these restorations depends heavily on the framework material used, including its resistance to microbial adhesion and its effect on peri-implant tissue health.
This randomized clinical trial compares two framework materials: Zirconia, a high-strength ceramic material, and Zantex, a fiber-reinforced polymer material, both used to fabricate mandibular hybrid prostheses supported by four implants placed following the All-on-Four protocol.
Microbial adhesion will be assessed by evaluating biofilm accumulation on the prosthesis frameworks retrieved under sterile conditions at set time intervals. Peri-implant tissue health will be evaluated clinically at 1 week, 2 weeks, 1 month, and 3 months following prosthesis delivery, using standard clinical parameters including modified plaque index, modified bleeding on probing, and probing depth.
A total of 14 patients (7 per group) will be enrolled based on sample size calculations targeting 90% statistical power.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Kafr el-Sheikh Governorate
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Kafr ash Shaykh、Kafr el-Sheikh Governorate、エジプト、33511
- 募集
- Faculty of Dentistry, Kafrelsheikh University
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コンタクト：
- Maged Alameri, BDS
- 電話番号：00201155617217 00201117599298
- メール：majed.alameri.07@hotmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Completely edentulous patients in the mandibular arch.
- Patients with a completely edentulous maxillary arch rehabilitated with a conventional complete denture.
- Patients with sufficient mandibular bone volume and quality to allow placement of four implants according to the All-on-Four treatment concept.
- Patients suitable for placement of two axial anterior implants in the canine regions and two distally tilted posterior implants anterior to the mental foramina.
- Patients with adequate restorative space to accommodate a full-arch hybrid prosthesis.
- Patients who are willing and able to maintain adequate oral hygiene and attend all scheduled follow-up appointments.
Patients who are willing to participate in the study and sign the informed consent form.
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Exclusion Criteria:
1. Patients with systemic conditions that contraindicate implant surgery or may adversely affect osseointegration or wound healing.
2. Patients receiving medications or undergoing treatments that significantly affect bone metabolism or healing.
3. Patients with a history of radiotherapy involving the head and neck region that may compromise implant therapy.
4. Patients with active or uncontrolled periodontal or oral infections. 5. Patients with inadequate mandibular bone volume or unfavorable anatomical conditions that prevent placement of four implants according to the planned All-on-Four protocol without additional augmentation procedures.
6. Patients with severe parafunctional habits, such as uncontrolled bruxism, that may compromise the prosthetic rehabilitation.
7. Patients unable or unwilling to maintain appropriate oral hygiene. 8. Patients unable to attend the scheduled follow-up visits. 9. Patients who decline to participate or fail to provide informed consent
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 |
|---|---|
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実験的：Zirconia Framework Group
Mandibular hybrid prosthesis fabricated with Zirconia framework, supported by four implants following the All-on-Four protocol.
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A metal-free zirconia ceramic framework used to fabricate a screw-retained mandibular hybrid prosthesis supported by four dental implants (All-on-Four protocol)
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実験的：Zantex Framework Group
Mandibular hybrid prosthesis fabricated with Zantex (fiber-reinforced polymer) framework, supported by four implants following the All-on-Four protocol.
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A fiber-reinforced polymer (Zantex) metal-free framework used to fabricate a screw-retained mandibular hybrid prosthesis supported by four dental implants (All-on-Four protocol).
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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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Microbial Adhesion on Prosthesis Framework
時間枠：At 1 week, 1 month, and 3 months after prosthesis delivery
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Quantitative assessment of bacterial biofilm accumulation on the intaglio surface of the prosthesis framework, measured using microbiological culture/colony counting techniques.
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At 1 week, 1 month, and 3 months after prosthesis delivery
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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 |
|---|---|---|
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Modified Plaque Index
時間枠：At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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Modified Plaque Index (mPI) assessed using a standardized plastic periodontal probe at multiple sites around each implant, scored on a scale from 0 to 3, where higher scores indicate greater plaque accumulation (worse outcome).
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At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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Modified Bleeding on Probing Index (mBOP)
時間枠：At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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Modified Bleeding on Probing (mBOP) assessed using a standardized plastic periodontal probe at multiple sites around each implant, scored on a scale from 0 to 3, where higher scores indicate greater bleeding tendency (worse outcome).
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At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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Probing Depth
時間枠：At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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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 (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
キーワード
その他の研究ID番号
- KFSIRB200-722
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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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