Clinical trial NCT06777303: Efficacy of Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis
Official title: Efficacy of Locally Applied Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Probing pocket depth reduction
timeFrame: 12 weeks
Secondary outcomes:
measure: plaque index
timeFrame: 12 weeks
measure: clinical attachment gain
timeFrame: 12 weeks
measure: Gingival Bleeding Index
timeFrame: 12 weeks
measure: o Total anti-oxidant capacity(T-AOC)
timeFrame: 12 weeks
measure: tumor necrosis factor alpha (TNF alpha)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dakahlia
Study officials:
References: