Effect of Advanced PRF and Hyaluronic Acid on Dental Implant Healing
Clinical Efficacy of A-PRF With Hyaluronic Acid" in Enhancing Bone Formation in Dental Implantation
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Samar A Salamah, BDS
- 電話番号：+967777277949
- メール：samarali777277949@gmail.com
研究場所
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Sana'a
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Sanaa、Sana'a、イエメン
- 募集
- Beauty Smile Dental Center
-
コンタクト：
- Samar A Salamah, BDS
- 電話番号：+967777277949
- メール：samarali777277949@gmail.com
-
コンタクト：
- Samar A Salamah, BDS
- メール：samarali777277949@gmail.com
-
-
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:
- Adults aged 18-65 years.
Patients requiring delayed dental implant placement in a posterior mandibular edentulous site
Sufficient residual alveolar bone height and width to permit conventional implant placement without the need for simultaneous guided bone regeneration (GBR), ridge augmentation, or other bone-grafting procedures.
Good general health or a medically controlled and stable systemic condition compatible with elective implant surgery and not expected to materially compromise wound or bone healing.
Non-smokers with no current use of tobacco products.
Acceptable oral hygiene and a periodontal condition compatible with implant surgery following any required professional treatment and reassessment.
Ability and willingness to undergo the required clinical and radiographic assessments, including CBCT examinations at baseline and at the 6-month follow-up.
Ability and willingness to attend the scheduled follow-up visits and comply with the study procedures.
Provision of written informed consent before study participation.
Exclusion Criteria:
-
Any uncontrolled systemic disease or medical condition that conensions for conventional implant placement without augmentation.
Requirement for immediate implant placement, simultaneous guided bone regeneration, ridge augmentation, or any other adjunctive bone-grafting procedure.
Inability or unwillingness to complete the required 6-month clinical and radiographic follow-up.traindicates elective implant surgery or may substantially impair wound or bone healing, including uncontrolled diabetes mellitus.
Immunocompromised status or current systemic immunosuppressive therapy.
Current or previous use of oral or parenteral bisphosphonates or other antiresorptive medications associated with a risk of medication-related osteonecrosis of the jaw.
Pregnancy at the time of screening or enrollment.
Unresolved active periodontal disease or active local infection involving the intended implant site, including suppuration.
Inadequate oral hygiene that persists after professional oral-hygiene instruction, necessary periodontal treatment, and reassessment.
Insufficient residual alveolar bone dim
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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Dental Implant + A-PRF and Hyaluronic Acid
Participants receive delayed dental implant placement with adjunctive application of advanced platelet-rich fibrin (A-PRF) combined with hyaluronic acid at the implant site.
|
A dental implant was surgically placed into a healed edentulous site using a standardized delayed-placement protocol.
This procedure was performed in both the test and control groups.
Autologous advanced platelet-rich fibrin (A-PRF) was prepared from the participants' venous blood using a standardized centrifugation protocol and applied at the dental implant site.
In the test group, A-PRF was used in combination with hyaluronic acid as an adjunct to delayed dental implant placement.
In the test group, 1.5% hyaluronic acid is combined with autologous advanced platelet-rich fibrin (A-PRF) and applied locally at the dental implant site during delayed dental implant placement.
The control group does not receive hyaluronic acid.
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アクティブコンパレータ：Dental Implant Alone
Participants receive delayed dental implant placement without adjunctive A-PRF or hyaluronic acid.
|
A dental implant was surgically placed into a healed edentulous site using a standardized delayed-placement protocol.
This procedure was performed in both the test and control groups.
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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 |
|---|---|---|
|
CBCT-Derived Peri-Implant Bone Volume
時間枠：Baseline and 6 months after implant placement
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The peri-implant bone volume will be assessed using cone-beam computed tomography (CBCT) at baseline and 6 months after dental implant placement.
Changes in bone volume between baseline and the 6-month follow-up will be evaluated and compared between the test and control groups.
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Baseline and 6 months after implant placement
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CBCT-Derived Peri-Implant Radiographic Density
時間枠：Baseline and 6 months after implant placement
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Peri-implant radiographic density will be assessed using cone-beam computed tomography (CBCT) at baseline and 6 months after dental implant placement.
Changes in radiographic density between baseline and the 6-month follow-up will be evaluated and compared between the test and control groups.
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Baseline and 6 months after implant placement
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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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Implant Stability Quotient (ISQ)
時間枠：At implant placement and 6 months after implant placement
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Implant stability will be assessed using resonance frequency analysis and expressed as Implant Stability Quotient (ISQ) values.
ISQ will be measured at the time of implant placement and at the 6-month follow-up, and changes will be compared between the test and control groups.
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At implant placement and 6 months after implant placement
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Dental Implant Survival Rate at 6 Months
時間枠：Up to 6 months after implant placement
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Implant survival will be assessed by determining whether the dental implant remains in situ and clinically functional without removal during the 6-month follow-up period.
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Up to 6 months after implant placement
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Samar A salamah, BDS、Sana'a University
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
その他の研究ID番号
- OMFS-033\06\2025
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
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。