Eggshell-Derived Hydroxyapatite With Platelet-Rich Fibrin for Bone Regeneration After Jaw Cyst Removal
Evaluation of Eggshell-Derived Hydroxyapatite Enhanced With Platelet-Rich Fibrin for Alveolar Bone Regeneration Following Cyst Enucleation
This clinical study aims to evaluate bone healing after the surgical removal of jaw cysts using a bone graft material made from chicken eggshells, with or without platelet-rich fibrin (PRF), a substance prepared from the patient's own blood.
Removal of a jaw cyst can leave an empty space in the surrounding bone. Although this space may heal naturally, bone regeneration can take several months. Hydroxyapatite is a bone-like mineral that may support new bone formation. Combining it with PRF may further improve healing.
This prospective, controlled clinical study is being conducted in Sana'a, Yemen. Participants undergo surgical removal of jaw cysts and receive one of the treatment approaches included in the study. The researchers compare bone healing between treatment groups using clinical examinations and dental imaging, including cone-beam computed tomography (CBCT).
Participants are followed for up to six months after surgery. The study evaluates bone regeneration, postoperative pain, wound healing, and possible complications.
The researchers aim to determine whether eggshell-derived hydroxyapatite combined with PRF improves bone regeneration compared with the other treatments being investigated.
調査の概要
状態
詳細な説明
This prospective, controlled, non-randomized interventional clinical study evaluates the clinical and radiographic outcomes of eggshell-derived hydroxyapatite (HA) enhanced with autologous platelet-rich fibrin (PRF) for alveolar bone regeneration following the enucleation of odontogenic jaw cysts.
The study is conducted in Sana'a, Yemen, among adult patients requiring surgical enucleation of jaw cysts associated with residual bone defects.
The investigational bone graft material is synthesized from processed chicken eggshells using a chemical preparation method involving phosphoric acid. The resulting calcium phosphate material undergoes physicochemical characterization and is prepared for clinical application under controlled aseptic conditions.
The clinical study includes three treatment groups. Participants are assigned using a repeating A-B-C allocation sequence rather than random assignment. The study evaluates eggshell-derived HA combined with autologous PRF against the other treatment approaches defined in the clinical protocol.
When PRF is used, venous blood is collected from the participant and centrifuged without anticoagulants to obtain a fibrin-rich preparation. The PRF is combined with the prepared HA material and applied to the residual bone defect after cyst enucleation.
Participants undergo standardized surgical management and postoperative clinical assessment. Clinical evaluations include wound healing, postoperative pain, swelling, infection, wound dehiscence, and other treatment-related complications.
Radiographic assessments include panoramic radiography and cone-beam computed tomography (CBCT). Bone regeneration is evaluated through changes in residual defect dimensions and radiographic healing during postoperative follow-up, including assessments at three and six months.
The primary objective is to compare radiographic bone regeneration following cyst enucleation among the treatment groups. Secondary objectives include evaluating soft tissue healing, postoperative discomfort, and treatment-related complications.
The study hypothesis is that eggshell-derived HA combined with autologous PRF may provide improved bone regeneration compared with the other treatment approaches. The investigation is intended to generate clinical evidence regarding the regenerative performance and safety of the locally prepared bone graft material.
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
-
-
-
Sanaa、イエメン
- 募集
- Faculty of Dentistry, Sana'a University
-
コンタクト：
- Ahmed N Mabkhout, M.D.S.
- 電話番号：00967778470470
- メール：ahmed.mabkhout77@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:**
- Adult patients aged 18 to 60 years.
- Patients diagnosed with odontogenic jaw cysts requiring surgical enucleation.
- Patients with residual jawbone defects measuring at least 1.5 cm following cyst enucleation.
- Patients in good general health or with medically controlled systemic conditions.
- Patients who provide informed consent to participate in the clinical study and agree to scheduled postoperative follow-up examinations.
**Exclusion Criteria:**
- Patients with an active infection at the surgical site.
- Patients with a history of radiation therapy or bisphosphonate use.
- Patients with systemic bone diseases or immunosuppression.
- Pregnant or lactating women.
- Patients with known allergies or intolerance to any materials used in the study.
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：非ランダム化
- 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 |
|---|---|
|
実験的：Group A: Eggshell-Derived HA + PRF
|
Following surgical enucleation of the odontogenic jaw cyst, the residual bone defect is filled with locally prepared eggshell-derived hydroxyapatite combined with autologous platelet-rich fibrin (PRF). The PRF is obtained from the patient's venous blood by centrifugation without anticoagulants. The combined graft is placed into the bone cavity before surgical wound closure. |
|
アクティブコンパレータ：Group B: Eggshell-Derived HA Alone
|
Following surgical enucleation of the odontogenic jaw cyst, the residual bone defect is filled with eggshell-derived hydroxyapatite without platelet-rich fibrin. The graft is placed directly into the bone cavity before surgical wound closure. |
|
介入なし：Group C: Spontaneous Bone Healing
|
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 |
|---|---|---|
|
Change in Alveolar Bone Defect Dimensions Following Cyst Enucleation
時間枠：Baseline and 3 and 6 months after surgery
|
Radiographic bone regeneration is assessed by measuring changes in the vertical and horizontal dimensions of the residual bone defect in millimeters using cone-beam computed tomography (CBCT). Measurements obtained at baseline are compared with those at 3 and 6 months after surgery to evaluate bone defect reduction among the treatment groups. |
Baseline and 3 and 6 months after surgery
|
|
Change in Radiographic Density Within the Healing Bone Defect
時間枠：Baseline and 3 and 6 months after surgery
|
Changes in radiographic density within the bone defect are evaluated using CBCT image gray values obtained from a defined region of interest. Measurements are compared between baseline and follow-up examinations at 3 and 6 months, using a consistent imaging and measurement protocol. Gray values are reported as relative radiographic measurements rather than calibrated Hounsfield units. |
Baseline and 3 and 6 months after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Pain Intensity
時間枠：1 week, 1 month, 3 months, and 6 months after surgery
|
Postoperative pain is assessed using a patient-reported visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores are recorded during postoperative follow-up visits and compared among the treatment groups. |
1 week, 1 month, 3 months, and 6 months after surgery
|
|
Clinical Soft Tissue Healing
時間枠：1 week, 1 month, 3 months, and 6 months after surgery
|
Healing of the surgical site is assessed clinically by examining mucosal wound closure and recording the presence or absence of swelling and wound dehiscence during postoperative follow-up visits. |
1 week, 1 month, 3 months, and 6 months after surgery
|
|
Incidence of Postoperative Complications
時間枠：From surgery through 6 months of postoperative follow-up
|
The number of participants experiencing postoperative complications, including surgical-site infection, wound dehiscence, or other documented procedure-related complications, is recorded and compared among the treatment groups. |
From surgery through 6 months of postoperative follow-up
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Moussa N, Fan Y, Dym H. Maxillofacial Bone Grafting Materials: 2021 Update. Dent Clin North Am. 2021 Jan;65(1):167-195. doi: 10.1016/j.cden.2020.09.012.
- Chiapasco M, Rossi A, Motta JJ, Crescentini M. Spontaneous bone regeneration after enucleation of large mandibular cysts: a radiographic computed analysis of 27 consecutive cases. J Oral Maxillofac Surg. 2000 Sep;58(9):942-8; discussion 949. doi: 10.1053/joms.2000.8732.
- Dragonas P, Katsaros T, Avila-Ortiz G, Chambrone L, Schiavo JH, Palaiologou A. Effects of leukocyte-platelet-rich fibrin (L-PRF) in different intraoral bone grafting procedures: a systematic review. Int J Oral Maxillofac Surg. 2019 Feb;48(2):250-262. doi: 10.1016/j.ijom.2018.06.003. Epub 2018 Jul 7.
- Kattimani V, Lingamaneni KP, Chakravarthi PS, Kumar TS, Siddharthan A. Eggshell-Derived Hydroxyapatite: A New Era in Bone Regeneration. J Craniofac Surg. 2016 Jan;27(1):112-7. doi: 10.1097/SCS.0000000000002288.
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
- 08/09/2O25:OMFS
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 (IPD) will not be shared with external researchers. Participant-level clinical and radiographic data will be kept confidential in accordance with the approved study protocol, institutional ethical requirements, and applicable data protection regulations. Aggregated and anonymized study results may be reported in scientific publications.
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。