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.

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.

Conditions

• Chronic Periodontitis

Interventions

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/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 & Collaborators

• Fayoum University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2027-06-30

Completion

2027-12-31

Countries

• Egypt

Study Locations