Chronic Periodontitis
Conditions
Keywords
deep periodontal pocket local drug Doxycycline Atorvastatin
Brief summary
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.
Detailed description
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.
Interventions
DRUGDoxycycline and Atorvastatin loaded Chitosan nanoparticles local 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.
Sponsors
Fayoum University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in periodontal parameters | From enrollment to the end of treatment at 6 months | Reduction in periodontal parameters including Probing pocket depth PPD (in mm), Clinical attachment level CAL (in mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in bleeding on probing | from enrollment to 6 months | 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. |
| Reduction in gingival index | from enrollment to 6 months | 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. |
| Reduction in plaque index | from enrollment to 6 months | 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: * 0: No plaque * 1: A thin, continuous band of plaque (up to 1 mm) at the cervical margin * 2: Plaque is present in a band wider than 1 mm but covers less than one-third of the tooth's surface * 3: Plaque covers at least one-third but less than two-thirds of the tooth's surface * 4: Plaque covers two-thirds or more of the tooth's surface Calculating the index: The scores from individual teeth are then used to calculate an overall plaque index for the entire mouth. |
| Radiographic improvement : | from enrollment to 6 months | 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 . |
Countries
Egypt
Contacts
CONTACTAmal mohamed ali Abdelgwad, bachelor
Outcome results
None listed