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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.

3 juni 2026 uppdaterad av: Amal Mohamed Ali Abelgwad, Fayoum University

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Amal mohamed ali Abdelgwad, bachelor
  • Telefonnummer: 201091369400
  • E-post: am3250@fayoum.edu

Studieorter

  • Egypten
      • Al Fayyum, Egypten
        • Fayoum

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: 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
Aktiv komparator: 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.
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Reduction in periodontal parameters
Tidsram: 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)
From enrollment to the end of treatment at 6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Reduction in bleeding on probing
Tidsram: 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.
from enrollment to 6 months
Reduction in gingival index
Tidsram: 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.
from enrollment to 6 months
Reduction in plaque index
Tidsram: 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.
from enrollment to 6 months
Radiographic improvement :
Tidsram: 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 .
from enrollment to 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Fayoum University

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

1 juni 2027

Avslutad studie (Beräknad)

1 december 2027

Studieregistreringsdatum

Först inskickad

3 juni 2026

Först inskickad som uppfyllde QC-kriterierna

3 juni 2026

Första postat (Faktisk)

8 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • FAY-DC,AV LOADED CS PERIO RCT

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NEJ

Läkemedels- och apparatinformation, studiedokument

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