Periodontal Regeneration Using Vitamin A and PRF Compared to PRF Alone Treating Intra-bony Defects

Cairo University (CU)

Status: Unknown

Conditions: Intrabony Periodontal Defect

Treatments: Biological: Platelet Rich Fibrin (PRF); Biological: Platelet Rich Fibrin (PRF) and Retinol

Study type: Interventional

Funder types: Other

Identifiers

NCT05285293

121221

Details and patient eligibility

About

Will the addition of vitamin A (Retinol) to PRF add more periodontal regenerative value in the treatment of intra-bony defects compared to PRF alone, clinically?

Full description

Vitamin A has been extensively studied for its role in bone health. Vitamin A can be consumed in two forms, i.e., preformed retinol and pro-vitamin A. Preformed retinol is often found in food originated from animals, such as dairy, liver and eggs. Provitamin A, such as alpha (α)-carotene, beta (β)-carotene orβ-cryptoxanthin, are commonly found in plant-based food, such as fruits and vegetables (Toti et al., 2018). At certain concentrations, it has been proven to enhance the pluripotency of periodontal cells for regeneration (Fawzy El-Sayed, Hein and Dörfer, 2019).

Yet, to the best of our knowledge no clinical trials have evaluated the effect of Vitamin A added to PRF in the regeneration of intra-bony defects. This study is to fill the gap of knowledge.

Enrollment: 28 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Stage III periodontitis patient (Papapanou et al., 2018) with 3 walled or 2 walled intra-bony defects.
• Non-smokers
• No pregnancy
• Medically free
• Presence of intra-bony defect of three or two walls (as predominant component) with a radiographic intra-bony component of ≥3 mm;
• Presence of ≥2 mm of keratinized gingiva at the tooth with the defect.
• Willingness to optimal compliance with the study procedures

Exclusion criteria

• Uncontrolled systemic or local infection in the tissue of interest,
• History or clinical evidence or positive tests for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV).
• History of chronic autoimmune disease
• Participation in an intervention trial in the same quadrant in the previous two months.
• Type III tooth mobility, vertical root fracture in the selected tooth.
• Contraindications for periodontal surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Group 1 Control

Active Comparator group

Description:

PRF in intra-bony defects

Treatment:

Biological: Platelet Rich Fibrin (PRF)

Group 2 Experimental

Experimental group

Description:

PRF and Retinol in intra-bony defects

Treatment:

Biological: Platelet Rich Fibrin (PRF) and Retinol