Clinical and Radiographic Evaluation of Doxycycline and Atorvastatin Loaded Chitosan Nanoparticles as an Adjunctive to Scaling and Root Planning in the Management of Chronic Periodontitis. A Randomized Controlled Clinical Trial.
Clinical and Radiographic Evaluation of Doxycycline and Atorvastatin Loaded Chitosan Nanoparticles as an Adjunctive to Scaling and Root Planning in the Management of Chronic Periodontitis: A Randomized Controlled Clinical Trial.
Chronic periodontitis is one of the most prevalent inflammatory diseases affecting the tooth-supporting structures and is characterized by progressive clinical attachment loss and alveolar bone resorption resulting from a complex interaction between pathogenic microorganisms and the host inflammatory and immune responses. If left untreated, the disease may ultimately lead to tooth loss and negatively affect oral health and quality of life.
Scaling and root planing (SRP) is considered the gold-standard non-surgical treatment for chronic periodontitis. It aims to remove dental plaque and calculus deposits and reduce the subgingival bacterial load. Although SRP has demonstrated significant clinical benefits, its effectiveness may be limited in certain situations, particularly in deep periodontal pockets and anatomically complex areas that are difficult to access. Therefore, adjunctive therapeutic approaches have been investigated to enhance treatment outcomes and improve long-term periodontal stability.
In recent years, local drug delivery systems have gained considerable attention in periodontal therapy due to their ability to provide high therapeutic concentrations directly at the site of infection while minimizing systemic adverse effects. Chitosan has emerged as a promising biomaterial for this purpose because of its excellent biocompatibility, biodegradability, antimicrobial properties, and its ability to form nanoparticles capable of sustained and controlled drug release within periodontal pockets.
Doxycycline is widely used in periodontal treatment because of its antimicrobial activity against periodontal pathogens as well as its ability to inhibit matrix metalloproteinases (MMPs), which play a key role in connective tissue destruction and alveolar bone loss. Furthermore, recent studies have demonstrated that atorvastatin, beyond its well-known lipid-lowering effects, possesses anti-inflammatory, immunomodulatory, and osteogenic properties that may contribute to periodontal tissue regeneration and improved clinical outcomes.
The research problem arises from the limited effectiveness of scaling and root planing alone in some cases of chronic periodontitis and the need for innovative adjunctive therapies that combine antimicrobial, anti-inflammatory, and bone regenerative effects. Therefore, evaluating the therapeutic potential of chitosan nanoparticles loaded with doxycycline and atorvastatin may provide a novel and effective approach for periodontal treatment.
The aim of this study is to clinically and radiographically evaluate the effectiveness of chitosan nanoparticles loaded with doxycycline and atorvastatin as an adjunct to scaling and root planing in patients with chronic periodontitis. Clinical outcomes, including probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), and bleeding on probing (BOP), as well as radiographic changes in alveolar bone levels, will be assessed and compared with conventional treatment outcomes. The findings of this study may contribute to the development of a more effective and biologically targeted therapeutic strategy for the management of chronic periodontitis.
調査の概要
状態
条件
詳細な説明
Chronic periodontitis is one of the most prevalent inflammatory diseases affecting the tooth-supporting structures and is characterized by progressive clinical attachment loss and alveolar bone resorption resulting from a complex interaction between pathogenic microorganisms and the host inflammatory and immune responses. If left untreated, the disease may ultimately lead to tooth loss and negatively affect oral health and quality of life.
Scaling and root planing (SRP) is considered the gold-standard non-surgical treatment for chronic periodontitis. It aims to remove dental plaque and calculus deposits and reduce the subgingival bacterial load. Although SRP has demonstrated significant clinical benefits, its effectiveness may be limited in certain situations, particularly in deep periodontal pockets and anatomically complex areas that are difficult to access. Therefore, adjunctive therapeutic approaches have been investigated to enhance treatment outcomes and improve long-term periodontal stability.
In recent years, local drug delivery systems have gained considerable attention in periodontal therapy due to their ability to provide high therapeutic concentrations directly at the site of infection while minimizing systemic adverse effects. Chitosan has emerged as a promising biomaterial for this purpose because of its excellent biocompatibility, biodegradability, antimicrobial properties, and its ability to form nanoparticles capable of sustained and controlled drug release within periodontal pockets.
Doxycycline is widely used in periodontal treatment because of its antimicrobial activity against periodontal pathogens as well as its ability to inhibit matrix metalloproteinases (MMPs), which play a key role in connective tissue destruction and alveolar bone loss. Furthermore, recent studies have demonstrated that atorvastatin, beyond its well-known lipid-lowering effects, possesses anti-inflammatory, immunomodulatory, and osteogenic properties that may contribute to periodontal tissue regeneration and improved clinical outcomes.
The research problem arises from the limited effectiveness of scaling and root planing alone in some cases of chronic periodontitis and the need for innovative adjunctive therapies that combine antimicrobial, anti-inflammatory, and bone regenerative effects. Therefore, evaluating the therapeutic potential of chitosan nanoparticles loaded with doxycycline and atorvastatin may provide a novel and effective approach for periodontal treatment.
The aim of this study is to clinically and radiographically evaluate the effectiveness of chitosan nanoparticles loaded with doxycycline and atorvastatin as an adjunct to scaling and root planing in patients with chronic periodontitis. Clinical outcomes, including probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), and bleeding on probing (BOP), as well as radiographic changes in alveolar bone levels, will be assessed and compared with conventional treatment outcomes. The findings of this study may contribute to the development of a more effective and biologically targeted therapeutic strategy for the management of chronic periodontitis.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Amal mohamed ali Abdelgwad, bachelor
- 電話番号：201091369400
- メール：am3250@fayoum.edu
研究場所
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Al Fayyum、エジプト
- Fayoum
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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:
- In order for patients to be considered in the study, they must meet the following criteria: 1) they should have stage II and stage III periodontitis 2) Patients' age range equal or more than 25 years old .
Exclusion Criteria:
- Patients with any systemic condition that may affect periodontal health and bone formation, such as; those who are pregnant, nursing, or postmenopausal women; DM, CVD, metabolic syndrome, osteoporosis, AIDS and chronic alcoholism .
2) Patients having local factors that may aggravate and predispose for periodontal diseases such as; orthodontic and prosthetic appliances and parafunctional habits 3)smoking (A patient was classified as a current smoker if they smoked more than 10 cigarettes per day regularly for a minimum period of 5 years) 4) Individuals on systemic drug affecting metabolic bone diseases , Medications taken for the treatment of arthritis and psychotropic and epileptic disorders, as well as anticoagulants, antacids, bisphosphonates, corticosteroids, and antineoplastic drugs, can profoundly affect bone metabolism
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：only scaling and root planning
patients will complete thorough full-mouth scaling and root planning (SRP), including the upper and lower jaws.
Under local anaesthesia, subgingival debridement will be achieved using periodontal Gracey curettes and an ultrasonic scaler
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アクティブコンパレータ：local drug after scaling and root planning
the group will go through the phase 1 therapy then will receive the local drug using a blunt cannula syringe (26 gauge), injecting 0.1 mL of the prepared drug gel into the periodontal pocket (one per patient).
After delivery, the gel will become more viscous and occluded the pockets, thus eliminating the need for placing periodontal dressing.
After LDD, patients will be instructed to avoid chewing on sticky/hard foodstuff or using toothbrush/interdental aids near the treated areas for 1 week.
All patients will receive the same postoperative instructions, and no mouthwashes or antibiotics will be prescribed after treatment.
|
the group will receive the local drug using a blunt cannula syringe (26 gauge), injecting 0.1 mL of the prepared drug gel into the periodontal pocket (one per patient).
After delivery, the gel will become more viscous and occluded the pockets, thus eliminating the need for placing periodontal dressing.
After LDD, patients will be instructed to avoid chewing on sticky/hard foodstuff or using toothbrush/interdental aids near the treated areas for 1 week.
All patients will receive the same postoperative instructions, and no mouthwashes or antibiotics will be prescribed after treatment.
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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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Reduction in periodontal parameters
時間枠：From enrollment to the end of treatment at 6 months
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Reduction in periodontal parameters including Probing pocket depth PPD (in mm), Clinical attachment level CAL (in mm)
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From enrollment to the end of treatment at 6 months
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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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Reduction in bleeding on probing
時間枠：from enrollment to 6 months
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It is measured at multiple sites per tooth and expressed as a percentage: the number of bleeding sites divided by the total number of sites probed, multiplied by 100.
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from enrollment to 6 months
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Reduction in gingival index
時間枠：from enrollment to 6 months
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It is measured by assessing redness, swelling, and bleeding, with a score of 0 being normal, 1 being mild inflammation, 2 for moderate inflammation, and 3 for severe inflammation.
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from enrollment to 6 months
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Reduction in plaque index
時間枠：from enrollment to 6 months
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Scoring: Based on the amount of plaque, each tooth or specific tooth surfaces are given a score from 0 to 5. A common scoring system is as follows:
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from enrollment to 6 months
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Radiographic improvement :
時間枠：from enrollment to 6 months
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Pre apical radiograph by parallel technique will be done in the first visit and it will be retaken after 6 months with the same technique .then
, the image will be subtracted digitally .
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from enrollment to 6 months
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
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- Yıldırım, Y., Kaya, S., & Demirci, T. (2023). Doxycycline- and atorvastatin-loaded chitosan nanoparticles as a local drug delivery system for periodontitis therapy: In vitro evaluation of antimicrobial activity and release profile. Journal of Drug Delivery Science and Technology, 78, 104145. https://doi.org/10.1016/j.jddst.2023.104145
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研究開始 (推定)
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