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
NCT ID: NCT06669026
Last Updated: 2024-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2023-09-01
2024-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
* 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.
TREATMENT
SINGLE
Study Groups
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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
vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel
Scaling and root debridement then inject gel in the pocket
only mechanical debridement
Scaling and root debridement
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
vitamin D3 gel (regular non-nanoparticle form)
Scaling and root debridement then inject gel in the pocket
only mechanical debridement
Scaling and root debridement
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
Poly lactic-co-glycolic acid nanoparticles placebo gel
Scaling and root debridement then inject gel in the pocket
only mechanical debridement
Scaling and root debridement
only mechanical debridement only
only mechanical debridement only.
only mechanical debridement
Scaling and root debridement
Healthy patients
healthy patients, only added for Interleukin 8 and alkaline phosphatase Elisa analysis
No interventions assigned to this group
Interventions
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vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel
Scaling and root debridement then inject gel in the pocket
vitamin D3 gel (regular non-nanoparticle form)
Scaling and root debridement then inject gel in the pocket
Poly lactic-co-glycolic acid nanoparticles placebo gel
Scaling and root debridement then inject gel in the pocket
only mechanical debridement
Scaling and root debridement
Eligibility Criteria
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Inclusion Criteria
* periodontal pocket ≤ 5 mm
Exclusion Criteria
* 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.
25 Years
55 Years
ALL
Yes
Sponsors
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Mansoura University
OTHER
Responsible Party
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Locations
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Alaaeldin Ahmed Taha
Cairo, , Egypt
Countries
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Other Identifiers
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A0103023OM
Identifier Type: -
Identifier Source: org_study_id
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