- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07634341
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Amal mohamed ali Abdelgwad, bachelor
- 전화번호: 201091369400
- 이메일: am3250@fayoum.edu
연구 장소
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-
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Al Fayyum, 이집트
- Fayoum
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Reduction in periodontal parameters
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Reduction in bleeding on probing
기간: 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
기간: 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
기간: 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 :
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Goldstein JL, Brown MS. Regulation of the mevalonate pathway. Nature. 1990 Feb 1;343(6257):425-30. doi: 10.1038/343425a0.
- Golub LM, Lee HM, Ryan ME, Giannobile WV, Payne J, Sorsa T. Tetracyclines inhibit connective tissue breakdown by multiple non-antimicrobial mechanisms. Adv Dent Res. 1998 Nov;12(2):12-26. doi: 10.1177/08959374980120010501.
- Bartold PM, Van Dyke TE. Periodontitis: a host-mediated disruption of microbial homeostasis. Unlearning learned concepts. Periodontol 2000. 2013 Jun;62(1):203-17. doi: 10.1111/j.1600-0757.2012.00450.x.
- Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
- Caffesse RG, Sweeney PL, Smith BA. Scaling and root planing with and without periodontal flap surgery. J Clin Periodontol. 1986 Mar;13(3):205-10. doi: 10.1111/j.1600-051x.1986.tb01461.x.
- Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.
- Calvo P, Remunan-Lopez C, Vila-Jato JL, Alonso MJ. Chitosan and chitosan/ethylene oxide-propylene oxide block copolymer nanoparticles as novel carriers for proteins and vaccines. Pharm Res. 1997 Oct;14(10):1431-6. doi: 10.1023/a:1012128907225.
- Goodman SB, Jiranek W, Petrow E, Yasko AW. The effects of medications on bone. J Am Acad Orthop Surg. 2007 Aug;15(8):450-60. doi: 10.5435/00124635-200708000-00002.
- Nicotine involved in periodontal disease through influence on cytokine profile in gingival crevicular fluid. Kamma, J. J., Giannopoulou, C., Vasdekis, V. G., & Mombelli, A. (2004). FEMS Immunology & Medical Microbiology, 52(2), 282-290. https://doi.org/10.1016/j.femspd.2004.03.008
- Alfuriji S, Alhazmi N, Alhamlan N, Al-Ehaideb A, Alruwaithi M, Alkatheeri N, Geevarghese A. The effect of orthodontic therapy on periodontal health: a review of the literature. Int J Dent. 2014;2014:585048. doi: 10.1155/2014/585048. Epub 2014 May 29.
- Albandar JM. Global risk factors and risk indicators for periodontal diseases. Periodontol 2000. 2002;29:177-206. doi: 10.1034/j.1600-0757.2002.290109.x. No abstract available.
- Ashokan DB, Shekar MK, Dharani K, Mani E, Pampani P, Ravichandran B. Clinical evaluation of photobiomodulation therapy and local 1.2% atorvastatin gel as an adjunct to subgingival instrumentation in patients with stage II periodontitis: a randomized controlled trial. Quintessence Int. 2025 Jul 21;56(7):514-527. doi: 10.3290/j.qi.b6218534.
- 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
- Madi, M., El-Din, S. A., & Elsaka, S. (2018). Evaluation of chitosan-doxycycline gel as a local drug delivery system in periodontal therapy. Journal of Periodontal Research, 53(5), 714-723. https://doi.org/10.1111/jre.12550
- Özdoğan, A. I. (2018). Local delivery of atorvastatin with chitosan gels enhances anti-inflammatory effects and periodontal tissue healing in experimental periodontitis. Drug Delivery, 25(1), 1353-1362. https://doi.org/10.1080/10717544.2018.1507060
- ) Rinaudo, M., Pavlov, G., & Desbrieres, J. (2006). Influence of the degree of deacetylation on some physico-chemical properties of chitosan films. Polymer, 47(25), 7201-7208. https://doi.org/10.1016/j.polymer.2006.09.027
- Petit, C., Layrolle, P., & Guicheux, J. (2019). Local delivery of statins in periodontal therapy: Clinical outcomes and mechanisms of action. Journal of Clinical Periodontology, 46(10), 1012-1024. https://doi.org/10.1111/jcpe.13190
- Zeiser, R., Bonig, H., & Henschler, R. (2018). Immunomodulatory effects of statins. Frontiers in Immunology, 9, 2864. https://doi.org/10.3389/fimmu.2018.02864
- Zhou, H., & Xie, Y. (2017). The role of statins in bone metabolism and periodontal health: A review. Drug Design, Development and Therapy, 11, 2157-2167. https://doi.org/10.2147/DDDT.S136488
- ) Herrera, D., & Matesanz, P. (2020). Local antimicrobial therapy in periodontics: Current concepts and clinical applications. Periodontology 2000, 83(1), 224-238. https://doi.org/10.1111/prd.12277
- ) Greenstein, G., & Tonetti, M. S. (2000). Local delivery of antimicrobial agents in the treatment of periodontitis: Scientific evidence and clinical relevance. Journal of Periodontology, 71(12), 1935-1947. https://doi.org/10.1902/jop.2000.71.12.1935
- Majzoub J, Salami A, Barootchi S, Tavelli L, Chan HL, Wang HL. The effect of non-surgical and surgical mechanical root debridement on infrabony defects: a retrospective study. Sci Rep. 2021 Oct 6;11(1):19856. doi: 10.1038/s41598-021-99205-z.
- Rodenburg JP, van Winkelhoff AJ, Winkel EG, Goene RJ, Abbas F, de Graff J. Occurrence of Bacteroides gingivalis, Bacteroides intermedius and Actinobacillus actinomycetemcomitans in severe periodontitis in relation to age and treatment history. J Clin Periodontol. 1990 Jul;17(6):392-9. doi: 10.1111/j.1600-051x.1990.tb00036.x.
- Newman, M. G., Takei, H., Klokkevold, P. R., & Carranza, F. A. (2019). Carranza's Clinical Periodontology (13th ed.). Elsevier.
- ) Research, Science and Therapy Committee of the American Academy of Periodontology. (2001). Position paper: Periodontal maintenance. Journal of Periodontology, 72(11), 1624-1628. https://doi.org/10.1902/jop.2001.72.11.1624
- Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
- Hajishengallis G, Darveau RP, Curtis MA. The keystone-pathogen hypothesis. Nat Rev Microbiol. 2012 Oct;10(10):717-25. doi: 10.1038/nrmicro2873. Epub 2012 Sep 3.
- Fernandes, M. I. S., Gaetti-Jardim, E., & Avila-Campos, M. J. (2017). Dysbiotic microbial community in periodontitis. Clinical Microbiology and Infection, 23(10), 840-846. https://doi.org/10.1016/j.cmi.2017.03.014
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FAY-DC,AV LOADED CS PERIO RCT
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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