骨内歯周欠損の治療におけるラクダ乳清タンパク質およびラクダ乳清タンパク質ナノ粒子の有効性
ランダム化臨床試験:骨内性歯周組織欠損治療におけるラクダホエイプロテインおよびラクダホエイプロテインナノ粒子の有効性の調査
Intraosseous bone defects (IOBDs) are a significant challenge in the treatment of periodontal disease. Several bone graft materials can be used for bone defect regeneration.
Camel whey protein (CWP) has emerged as a promising alternative due to its unique properties, including: High biological value containing essential amino acids, anti-inflammatory, antioxidant and immunomodulatory effects.
However, the therapeutic application of CWP for bone regeneration can be limited by its solubility and bioavailability . Nanoparticles offer a novel approach to enhance drug delivery and improve therapeutic efficacy. Introduction of bone grafts in the form of nanoparticles was found to improve the bioactivity and biocompatibility of artificial bone graft.
Nanoparticles (NPs) can efficiently enter biological organisms due to their very tiny size. The ability of NPs to easily pass through even the smallest blood capillaries and escape being phagocytized due to their small size (1-100 nm) extends their plasma half-life and permits a more progressive release of the medication. Nanoparticles have quicker absorption and a relatively greater drug loading arise from interactions at the surface. NPs increased antibacterial action may be attributed to their huge surface area and high charge density, which allows them to interact with the negatively charged surface of bacterial cells
調査の概要
詳細な説明
Periodontitis is clinically characterized by loss of gingival tissue attachment to the tooth, deepening of periodontal pocket, degradation of the periodontal ligament, and loss of alveolar bone. This destructive process is associated with the presence of subgingival microbial communities and dense immuno-inflammatory infiltrate in the periodontium that may lead to tooth loss if not appropriately treated.
Periodontitis is associated with a dysbiotic polymicrobial community, in which different members have distinct and synergistic roles that promote destructive inflammation. Inflammation, in turn, can exacerbate dysbiosis through provision of nutrients for the bacteria (derived from tissue breakdown products; eg, collagen peptides and hemecontaining compounds). Therefore, inflammation and dysbiosis are reciprocally reinforced and generate a positive-feedback loop. This self-sustaining loop may underlie the chronicity of periodontitis, the development of which requires a susceptible host.
Risk factors include the presence of bacteria that subvert the host response, systemic disease, smoking, aging and immune deficiencies. These factors could promote dysbiosis by acting individually or, more effectively, in combination.
Periodontal defects have been differentiated based on bone resorption patterns into "supraosseous" ("suprabony") and "infraosseous" ("infrabony") "). Infrabony defects are classified according to the location and number of osseous walls remaining around the pocket. According to the classification by Goldman & Cohen , inrtabony defects are categorized as follows: (i) one-wall intrabony defects: defects bounded by one osseous wall and the tooth surface; (ii) two-wall intrabony defects: defects bounded by two osseous walls and the tooth surface; (iii) three-wall intrabony defects: defects bounded by three osseous walls and the tooth surface.
It has been suggested that the term "intrabony" means "within or inside the bone", while "infrabony" means "below the crest of bone". The authors suggested that only 3-wall angular defects should be termed "intrabony", while all other vertical bony defects should be referred to as "infrabony".
Intraosseous bone defects (IOBDs) are a significant challenge in the treatment of periodontal disease. Several bone graft materials can be used for bone defect regeneration.
Camel whey protein (CWP) has emerged as a promising alternative due to its unique properties, including: High biological value containing essential amino acids, anti-inflammatory, antioxidant and immunomodulatory effects.
However, the therapeutic application of CWP for bone regeneration can be limited by its solubility and bioavailability . Nanoparticles offer a novel approach to enhance drug delivery and improve therapeutic efficacy. Introduction of bone grafts in the form of nanoparticles was found to improve the bioactivity and biocompatibility of artificial bone graft.
Nanoparticles (NPs) can efficiently enter biological organisms due to their very tiny size. The ability of NPs to easily pass through even the smallest blood capillaries and escape being phagocytized due to their small size (1-100 nm) extends their plasma half-life and permits a more progressive release of the medication. Nanoparticles have quicker absorption and a relatively greater drug loading arise from interactions at the surface. NPs increased antibacterial action may be attributed to their huge surface area and high charge density, which allows them to interact with the negatively charged surface of bacterial cells.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Kafrelsheikh
-
Kafr ash Shaykh、Kafrelsheikh、エジプト、214312
- faculty of dentistry, kafrelsheikh University
-
-
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:
- The patient age range will be 18-45 years of both sexes Stage III or IV periodontitis (probing depth ≥ 6 mm in teeth and clinical attachment ≥ 5 mm).
- Clinical and radiographic confirmation of 3 wall intrabony defects.
- Absence of any complicating systemic condition that may contraindicate surgical procedures.
- Adequate oral hygiene.
- Eligible participants should present good general health and agree to random assignment to any of the parallel study groups.
Exclusion Criteria:
- Allergy
- Uncontrolled systematic disorders as, diabetes mellitus, uncontrolled periodontal disease, history of head and neck radiotherapy, smokers, pregnancy, noncompliant patients, uncooperative individuals or those unable to attend the study follow-up appointments.
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:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Open currettage
open flap debridement |
only open flap granulation tissue debridement |
|
プラセボコンパレーター:Open curettage with scaffold material
scaffold material |
open flap debridement with defect filling with scaffold material |
|
アクティブコンパレータ:Open curettage with Camel whey protein
CWP |
open flap debridement with defect filling with CWP |
|
アクティブコンパレータ:Open curettage with Camel whey protein nanoparticle
CWP NPs |
open flap debridement with defect filling with CWP NPs |
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 |
|---|---|---|
|
bone fill
時間枠:6-months
|
Radiographic bone fill will be assessed using CBCT by subtracting the preoperative and postoperative x-rays, followed by measuring the resultant bone volume in mm³. |
6-months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
bone density
時間枠:6-months
|
radiogeaphic bone density will be assessed using CBCT |
6-months
|
|
Clinical probing pocket depths
時間枠:6-months
|
Clinical probing pocket depths will be measured in mm from gingival margin to the base of the sulcus using graduated periodontal probe |
6-months
|
|
clinical attachment level
時間枠:6-months
|
clinical attachment level will be measured in mm from cementoenamel junction to the base of the sulcus using graduated periodontal probe |
6-months
|
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 (実際)
研究の完了 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- KFSIRB200-317
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
undecided
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
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