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

NCT06669026 | Completed Phase 2

• 1 other identifier: A0103023OM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Pocket

Outcome Measures

Primary Outcomes (1)

• Periodontal Assessment

  Periodontal Index

  12 weeks

Secondary Outcomes (2)

• Interleukin 8

  8 weeks

• alkaline phosphatase

  8 weeks

Study Arms (5)

vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement

EXPERIMENTAL

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; Procedure: only mechanical debridement

vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement.

ACTIVE COMPARATOR

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

Dietary Supplement: vitamin D3 gel (regular non-nanoparticle form); Procedure: only mechanical debridement

Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement.

PLACEBO COMPARATOR

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

Other: Poly lactic-co-glycolic acid nanoparticles placebo gel; Procedure: only mechanical debridement

only mechanical debridement only

SHAM COMPARATOR

only mechanical debridement only.

Procedure: only mechanical debridement

Healthy patients

NO INTERVENTION

healthy patients, only added for Interleukin 8 and alkaline phosphatase Elisa analysis

Interventions

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

Scaling and root debridement then inject gel in the pocket

vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement

vitamin D3 gel (regular non-nanoparticle form) DIETARY_SUPPLEMENT

Scaling and root debridement then inject gel in the pocket

vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement.

Poly lactic-co-glycolic acid nanoparticles placebo gel OTHER

Scaling and root debridement then inject gel in the pocket

Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement.

only mechanical debridement PROCEDURE

Scaling and root debridement

Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement.; only mechanical debridement only; vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement.; vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with attachment loss 3-4 mm
• periodontal pocket ≤ 5 mm

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Alaaeldin Ahmed Taha

Cairo, 11851, Egypt

Location

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 1, 2024
• Study Start: September 1, 2023
• Primary Completion: March 15, 2024
• Study Completion: September 20, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

EG (1)