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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:
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
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 (-ve control group) SRP alone | Active Comparator | are treated with scaling and root planning alone |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura university | Al Mansurah | Dakahlia Governorate | 0000 | Egypt |
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| 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 |
|
| scaling and root planning | Procedure | the -ve control group in the study |
|
| chitosan nano-particles | Drug | the +ve control group in the study |
|
| 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 |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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