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Completed

NCT Number: NCT06669026

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

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.

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Key information

Conditions

Periodontal Pocket Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alaaeldin Ahmed Taha

Cairo, 11851, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel

Dietary Supplement

Scaling and root debridement then inject gel in the pocket

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

Primary outcomes

  1. Periodontal Assessment

    Time frame: 12 weeks

    Periodontal Index

Secondary outcomes

  1. Interleukin 8

    Time frame: 8 weeks

    level of interleukin 8 in gingival crevicular fluid will be tested via elisa

  2. alkaline phosphatase

    Time frame: 8 weeks

    level of alkaline phosphatase in gingival crevicular fluid will be tested via elisa

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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