Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement
Evaluation of Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement in the Maxillary Posterior Area
Implants placed immediately after tooth extraction usually present challenges in obtaining soft tissue coverage with high risk of bacterial invasion, wound dehiscence and subsequently adverse effect on the success rate of the implant due to lack of primary soft tissue closure over the implant.
Different surgical methods have been described to achieve primary soft tissue closure in maxillary fresh socket, each having its advantages and disadvantages, based on that, buccal pad of fat can solve this soft tissue coverage problem with minimal complications and high success rate of the placed implants.The objective of this study is to evaluate the use of buccal pad of fat tissue with immediate implant placement in the posterior maxillary area.
調査の概要
詳細な説明
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Dina Y. Attia, MSc
- 電話番号：+01017510444
- メール：dina.youssef29@gmail.com
研究連絡先のバックアップ
- 名前：Lobna Elwan, BSc
- メール：lobnaelwan@gmail.com
参加基準
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:
- Patients age between 20-45 years with no gender predilection.
- Patients with non-restorable maxillary posterior tooth which need to be extracted (premolar -molar region).
- Patients with good oral hygiene.
- Bony defects more than 2 mm during implant placement treated by bone substitute.
- Patients fully capable to comply with the study protocol.
Exclusion Criteria:
- Patients with any systemic disease affecting bone quality as uncontrolled diabetes.
- Heavy smokers (more than 20 cigarettes per day).
- Sites with acute oral infection.
- Pregnant and lactating patients.
- Untreated periodontal disease.
- Previous chemotherapy or irradiation of the head and neck.
- Inadequate interocclusal space.
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Intervention group
10 patients will have immediate implant placement with buccal pad of fat free tissue
|
Xenograft bone substitute will be placed over the implant to cover the bone defect after extraction.
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
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluate postoperative pain when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
時間枠：6 months
|
Postoperative pain will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using: a 10-point Visual Analogue Scale (VAS) (17) from 0 to 10 (0 no pain, to 10 severe pain). |
6 months
|
|
Evaluate swelling when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
時間枠：6 months
|
Postoperative swelling will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using a 10-point scale with 4 parameters will be used: none (no swelling), light (intraoral, localized to the treated area), moderate (extraoral swelling localized to the treated area), and severe (extraoral swelling extending beyond the treated area)
|
6 months
|
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Evaluate soft tissue healing when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
時間枠：6 months
|
Evaluation of soft tissue healing At week 1, week4 and at 6 months: Presence/absence of postoperative complications will be evaluated, including: Bleeding, hematoma, wound dehiscence, local infection, partial flap necrosis, excessive granulation tissue or vestibular obliteration, edema, facial asymmetry and mouth opening limitation. |
6 months
|
|
Evaluate implant stability when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area
時間枠：6 months
|
Implant stability will be measured by implant stability meter (OsstellTM), immediately postoperative and after 6 months.
|
6 months
|
|
Radiographic evaluation for using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
時間枠：6 months
|
After 3 months then at 6 months Cone Beam CT will be requested in order to measure:
|
6 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Lobna Elwan, BSc、Alexandria University
- スタディディレクター：Nagy El Prince, PhD、Alexandria University
- スタディディレクター：Ahmed O. Swedan, PhD、Alexandria University
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 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
- Buccal pad of fat free tissue
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
米国で製造され、米国から輸出された製品。
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