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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| only scaling and root planning | No Intervention | 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 | |
| local drug after scaling and root planning | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline and Atorvastatin loaded Chitosan nanoparticles local drug | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in periodontal parameters | Reduction in periodontal parameters including Probing pocket depth PPD (in mm), Clinical attachment level CAL (in mm) | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in bleeding on probing | 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. | from enrollment to 6 months |
| Reduction in gingival index |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amal mohamed ali Abdelgwad, bachelor | Contact | 201091369400 | am3250@fayoum.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayoum | Al Fayyum | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| 17664365 | Background | 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. |
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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. |
| from enrollment to 6 months |
| Reduction in plaque index | 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:
| from enrollment to 6 months |
| Radiographic improvement : | 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 . | from enrollment to 6 months |
| Background | 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 |
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| 40377185 | Background | 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. |
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| Background | 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 |
| Background | 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 |
| Background | 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 |
| Background | ) 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 |
| Background | 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 |
| Background | Zeiser, R., Bonig, H., & Henschler, R. (2018). Immunomodulatory effects of statins. Frontiers in Immunology, 9, 2864. https://doi.org/10.3389/fimmu.2018.02864 |
| Background | 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 |
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| 32383274 | Background | 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. |
| 34615954 | Background | 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. |
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| Background | Newman, M. G., Takei, H., Klokkevold, P. R., & Carranza, F. A. (2019). Carranza's Clinical Periodontology (13th ed.). Elsevier. |
| Background | ) 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 |
| 29926952 | Background | 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. |
| 23574467 | Background | 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. |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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