Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The proposed study aims to investigate the impact of adjunctive vitamin D gel application on gingival crevicular fluid levels of alkaline phosphatase and interleukin-8 in periodontitis patients undergoing phase 1 periodontal therapy. By elucidating the molecular mechanisms underlying the therapeutic effects of vitamin D, this research seeks to contribute to the development of more effective treatment strategies for periodontitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement | Experimental | vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil |
|
| vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement. | Active Comparator | vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil |
|
| Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement. | Placebo Comparator | Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil |
|
| only mechanical debridement only | Sham Comparator | only mechanical debridement only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel | Dietary Supplement | Scaling and root debridement then inject gel in the pocket |
|
| Measure | Description | Time Frame |
|---|---|---|
| Periodontal Assessment | Periodontal Index | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin 8 | level of interleukin 8 in gingival crevicular fluid will be tested via elisa | 8 weeks |
| alkaline phosphatase | level of alkaline phosphatase in gingival crevicular fluid will be tested via elisa |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaaeldin Ahmed Taha | Cairo | 11851 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Group 1: vitamin D3-loaded Poly lactic-co-glycolic acid (PLGA) nanoparticles gel as an adjunct to mechanical debridement.
Not provided
Not provided
Not provided
|
| Healthy patients | No Intervention | healthy patients, only added for Interleukin 8 and alkaline phosphatase Elisa analysis |
| vitamin D3 gel (regular non-nanoparticle form) | Dietary Supplement | Scaling and root debridement then inject gel in the pocket |
|
| Poly lactic-co-glycolic acid nanoparticles placebo gel | Other | Scaling and root debridement then inject gel in the pocket |
|
| only mechanical debridement | Procedure | Scaling and root debridement |
|
| 8 weeks |
| ID | Term |
|---|---|
| D010514 | Periodontal Pocket |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided