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

NCT ID: NCT06777303

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-02
• Study Completion Date: 2025-09-30

Brief Summary

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)

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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group 1 (-ve control group) SRP alone

are treated with scaling and root planning alone

Group Type: ACTIVE_COMPARATOR

scaling and root planning

Intervention Type: PROCEDURE

the -ve control group in the study

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.

Group Type: ACTIVE_COMPARATOR

chitosan nano-particles

Intervention Type: DRUG

the +ve control group in the study

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.

Group Type: EXPERIMENTAL

curcurmin loaded on chitosan nano-particles

Intervention Type: DRUG

the formulation of curcumin and incorprating it with chitosan nano-particles will increase the absorption rate in the gingival sulcus

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.

Group Type: EXPERIMENTAL

hyaluronic acid loaded on chitosan nano-particles

Intervention Type: DRUG

the formulation of hyaluronic acid and incorprating it with chitosan nano-particles will increase the absorption rate in the gingival sulcus

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

scaling and root planning

the -ve control group in the study

Intervention Type: PROCEDURE

chitosan nano-particles

the +ve control group in the study

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

A05010240M

Identifier Type: -

Identifier Source: org_study_id