[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643839":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":43,"collaborators":12,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":12,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":12,"enrollmentInfo":56,"targetDuration":12,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":67,"whyStopped":12,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Fayoum University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"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",null,{"label":14,"type":15,"description":16,"interventionNames":17},"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\u002Fhard foodstuff or using toothbrush\u002Finterdental 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.",[18],"Drug: Doxycycline and Atorvastatin loaded Chitosan nanoparticles local drug",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","Doxycycline 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\u002Fhard foodstuff or using toothbrush\u002Finterdental 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.",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Amal mohamed ali Abdelgwad, bachelor","CONTACT","201091369400","am3250@fayoum.edu",[32],{"facility":33,"status":12,"city":34,"state":12,"zip":12,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":12},"Fayoum","Al Fayyum","Egypt","EG",{"type":38,"coordinates":39},"Point",[40,41],30.8418,29.30995,{"lat":41,"lon":40},{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Amal Mohamed Ali Abelgwad","Amal Mohamed Ali Abdelgwad","100643839","phase-4-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-100643839",false,"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.","Inclusion Criteria:\n\n* 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 .\n\nExclusion Criteria:\n\n\\- 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 .\n\n2\\) 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","ALL","25 Years",{"count":57,"type":58},80,"ESTIMATED","INTERVENTIONAL",[61],"PHASE4","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.\n\nScaling 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.\n\nIn 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.\n\nDoxycycline 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.\n\nThe 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.\n\nThe 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.",[64],"Chronic Periodontitis",[66],"deep periodontal pocket local drug Doxycycline Atorvastatin","NOT_YET_RECRUITING","2026-06-03",{"date":70,"type":71},"2026-06-08","ACTUAL",{"date":73,"type":58},"2026-06",{"date":75,"type":58},"2027-12",{"name":5,"class":6},1]