Efficacy of Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis

Efficacy of Locally Applied Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis Patients

to evaluate Efficacy of Locally Applied Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis patients

Materials and methods: forty patients (n=40) were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University, The participants forty patients are classified into four groups:

• Group1 : (-ve control group): SRP alone
• Group2: (+ve control group): SRP+ chitosan Nano-particles
• Group3: SRP + Curcumin-coated chitosan Nano-particles
• Group4: SRP+ hyaluronic acid -coated chitosan Nano-particle

All Patients will undergo Phase I therapy, which includes scaling and root planing using ultrasonic tips and gracey curettes. Additionally, mechanical oral hygiene instructions will be provided, and participants will be advised to refrain from using any mouthwash throughout the duration of the study.

Furthermore, patients within groups 2 to 4 will be subjected to an extra measure involving the application of the respective gel associated with their designated group. The gel will be administered on a weekly basis for duration of five weeks.

Clinical indices (plaque index (PI), gingival index (GI), clinical attachment level (CAL), and probing depth (PD)). Laboratory assessment will be done at baseline and final assessment( after 3 months) . tess will be for antioxdiant levels and TNF alpha

• Total anti-oxidant capacity(T-AOC) using Assay kit50T
• TNF alpha using ELISA Kit (96T)

Study Overview

• Status: Active, not recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: scaling and root planning; Drug: chitosan nano-particles; Drug: curcurmin loaded on chitosan nano-particles; Drug: hyaluronic acid loaded on chitosan nano-particles

Detailed Description

Inclusion criteria:

Patients who are systemically healthy Patient exhibiting periodontal pocket depths (PD) ≤5mm presence of clinical attachment loss (CAL) between 1-4mm cooperative individuals capable of adhering to mechanical oral hygiene instructions Patients who agreed on both written and verbal consent to participate in the study.

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o Exclusion criteria: patients with recent history of periodontal treatment (within the last 3 months) patients with recent use of antibiotic (within the past 3 months, pregnant or lactating women, individuals who are malnourished and taking vitamin supplements, Patients who regularly use mouthwashes.

Method of gel application: a blunt 2ml syringe will be used to administer the gel sub-gingivally until the pocket is filled

Cervicular fluid collection :

This is done at baseline and after 12 weeks

• Insert absorbent paper points gently into the gingival crevice at the sulcus or pocket depth.
• Allow the absorbent material to remain in the crevice for a specific duration (1 minute) to enable the collection of gingival crevicular fluid.
• Carefully retrieve the paper points from the gingival crevice, ensuring that the collected fluid is preserved on the material.
• Place the paper points in eppendorf tubes
• Handle the samples with care to prevent contamination and promptly transport them to the laboratory for further analysis. If necessary, samples may undergo centrifugation to separate cells and debris from the fluid.

Periodontal assessment:

The following periodontal indices will be assessed at baseline, and after 12 weeks o Plaque Index according to Silness P. Loe H 1964

• Gingival Bleeding Index/Bleeding On Probing(BOP) according to Ainamo & Bay 1975
• Probing pocket depth (PPD) is measured from free gingival margin to base of the pocket.
• Clinical attachment loss (CAL) is measured from cemento-enemal junction to base of the pocket.

the determination of the sample size was guided by reference of similar articles. . Employing G power for the calculation, the sample size was determined with a 0.676 effect size, a two-tailed test, α error set at 0.05, and a power of 0.8, resulting in a total calculated sample size of 10 individuals in each group.

Pretreatment period Participants were informed about the purpose of the study and screened for eligibility. They also were informed about the treatment received and the steps done, including non-surgical treatment and gel application with the associated risks, possible effects, and other treatment options available. The participants understood this explanation in broad terms according to the rules of the ethical committee of the Faculty of Dentistry, Mansoura University. Additionally, they acknowledged that they would be required to attend the periodic recall visits and that they are legally competent to give written informed consent before performing any required steps.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 0000
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who are systemically healthy
• Patient exhibiting periodontal pocket depths (PD) ≤5mm
• presence of clinical attachment loss (CAL) between 1-4mm
• cooperative individuals capable of adhering to mechanical oral hygiene instructions
• Patients who agreed on both written and verbal consent to participate in the study.

Exclusion Criteria:

• patients with recent history of periodontal treatment (within the last 3 months)
• patients with recent use of antibiotic (within the past 3 months)
• pregnant or lactating women,
• individuals who are malnourished and taking vitamin supplements,
• Patients who regularly use mouthwashes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1 (-ve control group) SRP alone; are treated with scaling and root planning alone	Procedure: scaling and root planning; the -ve control group in the study
Active Comparator: group 2 ( +ve control group) SRP + chitosan nano-particles LDD; patients are treated with SRP in addition to chitosan nano-particles as an adjunct local drug delivery.	Drug: chitosan nano-particles; the +ve control group in the study
Experimental: group 3 ( experimental group 1) SRP + curcumin loaded on chitosan nano-particles; patients are treated with SRP in addition to curcumin loaded on chitosan nano-particles as an adjunct local drug delivery.	Drug: curcurmin loaded on chitosan nano-particles; the formulation of curcumin and incorprating it with chitosan nano-particles will increase the absorption rate in the gingival sulcus
Experimental: group 4 ( experimental group 2) SRP + hyaluronic acid loaded on chitosan nano-particles; patients are treated with SRP in addition to hyaluronic-acid loaded on chitosan nano-particles as an adjunct local drug delivery.	Drug: hyaluronic acid loaded on chitosan nano-particles; the formulation of hyaluronic acid and incorprating it with chitosan nano-particles will increase the absorption rate in the gingival sulcus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth reduction	pocket depth is calculated using a UNC 15 perio probe to calculate the distance between the base of the pocket to the free gingival margin	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plaque index	according to Silness P. Loe H 1964	12 weeks
clinical attachment gain	measured from cemento-enemal junction to base of the pocket	12 weeks
Gingival Bleeding Index	according to Ainamo & Bay 1975	12 weeks
o Total anti-oxidant capacity(T-AOC)	laboratory investigation using Assay kit50T	12 weeks
tumor necrosis factor alpha (TNF alpha)	laboratory investigation using ELISA Kit (96T)	12 weeks

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 18, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants; Antimetabolites; Protective Agents; Adjuvants, Immunologic; Chelating Agents; Sequestering Agents; Viscosupplements; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hyaluronic Acid; Chitosan
• Other Study ID Numbers: A05010240M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No