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

NCT06777303 | Active Not Recruiting

• 1 other identifier: A05010240M
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• plaque index

  12 weeks

• clinical attachment gain

  12 weeks

• Gingival Bleeding Index

  12 weeks

• o Total anti-oxidant capacity(T-AOC)

  12 weeks

• tumor necrosis factor alpha (TNF alpha)

  12 weeks

Study Arms (4)

group 1 (-ve control group) SRP alone

ACTIVE COMPARATOR

are treated with scaling and root planning alone

Procedure: scaling and root planning

group 2 ( +ve control group) SRP + chitosan nano-particles LDD

ACTIVE COMPARATOR

patients are treated with SRP in addition to chitosan nano-particles as an adjunct local drug delivery.

Drug: chitosan nano-particles

group 3 ( experimental group 1) SRP + curcumin loaded on chitosan nano-particles

EXPERIMENTAL

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

group 4 ( experimental group 2) SRP + hyaluronic acid loaded on chitosan nano-particles

EXPERIMENTAL

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

Interventions

curcurmin loaded on chitosan nano-particles DRUG

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

group 3 ( experimental group 1) SRP + curcumin loaded on chitosan nano-particles

hyaluronic acid loaded on chitosan nano-particles DRUG

the formulation of hyaluronic acid 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

scaling and root planning PROCEDURE

the -ve control group in the study

group 1 (-ve control group) SRP alone

chitosan nano-particles DRUG

the +ve control group in the study

group 2 ( +ve control group) SRP + chitosan nano-particles LDD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Dakahlia Governorate, 0000, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: June 2, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

EG (1)