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

Cairo University28 enrolled

Overview

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?

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Intrabony Periodontal Defect

Interventions

Platelet Rich Fibrin (PRF)BIOLOGICAL

Platelet rich fibrin (PRF) in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST)

Platelet Rich Fibrin (PRF) and RetinolBIOLOGICAL

Platelet rich fibrin (PRF) mixed with Retinol in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

Radiographic linear defect depth

Measured as the depth of intra-osseous defect from the alveolar crest to the defect base (E et al., 2004)

Time frame: 6 Month

Secondary Outcomes

Clinical attachment level

clinical attachment level measured in mm. using williams graduated probe(SP, 1967)

Time frame: 6 Month

Probing pocket depth

Measuring probing depth in mm using William's graduated Periodontal probe (SP, 1967)

Time frame: 6 Month

Radiographic defect bone density

Bone density will be measured using Digital Radiographs using ImageJ software (B et al., 2019)

Time frame: 6 MOnth

Central Contacts

Abdallah H. Mostafa, M.Sc.

CONTACT

+2001005682509 dr.abdallah.hassan@gmail.com

Data from ClinicalTrials.gov

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