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

Therapeutic Efficacy of Local Vitamin D Drug as an Adjunct to Mechanical Debridement in the Treatment of Periodontitis

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 Overview

• Status: Completed
• Conditions: Periodontal Pocket
• Intervention / Treatment: Dietary supplement: vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel; Procedure: only mechanical debridement; Dietary supplement: vitamin D3 gel (regular non-nanoparticle form); Other: Poly lactic-co-glycolic acid nanoparticles placebo gel

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11851
    • Alaaeldin Ahmed Taha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel; Scaling and root debridement then inject gel in the pocket; Procedure: only mechanical debridement; Scaling and root debridement
Active Comparator: 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	Procedure: only mechanical debridement; Scaling and root debridement; Dietary supplement: vitamin D3 gel (regular non-nanoparticle form); Scaling and root debridement then inject gel in the pocket
Placebo Comparator: 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	Procedure: only mechanical debridement; Scaling and root debridement; Other: Poly lactic-co-glycolic acid nanoparticles placebo gel; Scaling and root debridement then inject gel in the pocket
Sham Comparator: only mechanical debridement only; only mechanical debridement only.	Procedure: only mechanical debridement; Scaling and root debridement
No Intervention: Healthy patients; healthy patients, only added for Interleukin 8 and alkaline phosphatase Elisa analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal Assessment	Periodontal Index	12 weeks

Secondary Outcome Measures

Outcome Measure	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	8 weeks

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Periodontal Pocket; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Dermatologic Agents; Bone Density Conservation Agents; Micronutrients; Keratolytic Agents; Vitamin D; Ergocalciferols; Vitamins; Cholecalciferol; Glycolic acid
• Other Study ID Numbers: A0103023OM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No