Therapeutic Efficacy of Local Vitamin D Drug as an Adjunct to Mechanical Debridement in the Treatment of Periodontitis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Periodontal Assessment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement
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
Intervention: vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel (Dietary Supplement)
vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement
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
Intervention: only mechanical debridement (Procedure)
vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement.
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
Intervention: vitamin D3 gel (regular non-nanoparticle form) (Dietary Supplement)
vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement.
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
Intervention: only mechanical debridement (Procedure)
Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement.
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
Intervention: Poly lactic-co-glycolic acid nanoparticles placebo gel (Other)
Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement.
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
Intervention: only mechanical debridement (Procedure)
only mechanical debridement only
only mechanical debridement only.
Intervention: only mechanical debridement (Procedure)
Healthy patients
healthy patients, only added for Interleukin 8 and alkaline phosphatase Elisa analysis
Outcomes
Primary Outcomes
Periodontal Assessment
Time Frame: 12 weeks
Periodontal Index
Secondary Outcomes
- Interleukin 8(8 weeks)
- alkaline phosphatase(8 weeks)