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

Clinical Evaluation of Periodontal Regeneration Using Vitamin A Added to PRF in Comparison to PRF Alone in Treatment of Intra-bony Defects: Randomized Controlled Clinical Trial

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Intrabony Periodontal Defect
• Intervention / Treatment: Biological: Platelet Rich Fibrin (PRF); Biological: Platelet Rich Fibrin (PRF) and Retinol

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdallah H. Mostafa, M.Sc.; Phone Number: +2001005682509; Email: dr.abdallah.hassan@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 Control; PRF in intra-bony defects	Biological: Platelet Rich Fibrin (PRF); Platelet rich fibrin (PRF) in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST)
Experimental: Group 2 Experimental; PRF and Retinol in intra-bony defects	Biological: Platelet Rich Fibrin (PRF) and Retinol; Platelet rich fibrin (PRF) mixed with Retinol in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic linear defect depth	Measured as the depth of intra-osseous defect from the alveolar crest to the defect base (E et al., 2004)	6 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level	clinical attachment level measured in mm. using williams graduated probe(SP, 1967)	6 Month
Probing pocket depth	Measuring probing depth in mm using William's graduated Periodontal probe (SP, 1967)	6 Month
Radiographic defect bone density	Bone density will be measured using Digital Radiographs using ImageJ software (B et al., 2019)	6 MOnth

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Abdallah H. Mostafa, M.Sc, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: 121221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Inclusion, exclusion criteria, Methodology and Results
• IPD Sharing Time Frame: Data will be available once the study is over and for one year
• IPD Sharing Access Criteria: by emailing " Dr.abdallah.hassan@gmail.com"
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No