Mansoura university
Al Mansurah, Dakahlia Governorate, 0000, Egypt
NCT Number: NCT06777303
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)
This study is active but is not currently recruiting participants.
All sexes
Interventional
Not applicable
Al Mansurah, Dakahlia Governorate, 0000, Egypt
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.
6
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
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
the formulation of curcumin and incorprating it with chitosan nano-particles will increase the absorption rate in the gingival sulcus
the formulation of hyaluronic acid and incorprating it with chitosan nano-particles will increase the absorption rate in the gingival sulcus
the -ve control group in the study
the +ve control group in the study
Time frame: 12 weeks
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
Time frame: 12 weeks
according to Silness P. Loe H 1964
Time frame: 12 weeks
measured from cemento-enemal junction to base of the pocket
Time frame: 12 weeks
according to Ainamo & Bay 1975
Time frame: 12 weeks
laboratory investigation using Assay kit50T
Time frame: 12 weeks
laboratory investigation using ELISA Kit (96T)
Mansoura University
Other
Efficacy of Locally Applied Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis Patients
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