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

Mansoura University

Status and phase

Completed

Phase 2

Conditions

Periodontal Pocket

Treatments

Procedure: only mechanical debridement

Dietary Supplement: vitamin D3 gel (regular non-nanoparticle form)

Other: Poly lactic-co-glycolic acid nanoparticles placebo gel

Dietary Supplement: vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel

Study type

Interventional

Funder types

Other

Identifiers

NCT06669026

A0103023OM

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

50 participants in 5 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

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 group

Description:

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

Treatment:

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 group

Description:

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

Treatment:

Other: Poly lactic-co-glycolic acid nanoparticles placebo gel

Procedure: only mechanical debridement

only mechanical debridement only

Sham Comparator group

Description:

only mechanical debridement only.

Treatment:

Procedure: only mechanical debridement

Healthy patients

No Intervention group

Description: