Periodontal Pocket
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTvitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel
Scaling and root debridement then inject gel in the pocket
DIETARY_SUPPLEMENTvitamin D3 gel (regular non-nanoparticle form)
Scaling and root debridement then inject gel in the pocket
OTHERPoly lactic-co-glycolic acid nanoparticles placebo gel
Scaling and root debridement then inject gel in the pocket
PROCEDUREonly mechanical debridement
Scaling and root debridement
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Group 1: vitamin D3-loaded Poly lactic-co-glycolic acid (PLGA) nanoparticles gel as an adjunct to mechanical debridement. * Group 2: vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement. * Group 3: placebo gel as an adjunct to mechanical debridement. * Group 4: only mechanical debridement.
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with attachment loss 3-4 mm * periodontal pocket ≤ 5 mm
Exclusion criteria
* \- Patients with sensitivity to the medication used in the study. * Patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study. * Patients with systemic diseases. * Pregnant and lactating females. * Smokers and tobacco chewers. * Patients not compliant with oral hygiene procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal Assessment | 12 weeks | Periodontal Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin 8 | 8 weeks | level of interleukin 8 in gingival crevicular fluid will be tested via elisa |
| alkaline phosphatase | 8 weeks | level of alkaline phosphatase in gingival crevicular fluid will be tested via elisa |
Countries
Egypt
Outcome results
None listed