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

NCT ID: NCT05285293

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-12-01

Brief Summary

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?

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.

Conditions

Intrabony Periodontal Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 Control

PRF in intra-bony defects

Group Type: ACTIVE_COMPARATOR

Platelet Rich Fibrin (PRF)

Intervention Type: BIOLOGICAL

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

Group 2 Experimental

PRF and Retinol in intra-bony defects

Group Type: EXPERIMENTAL

Platelet Rich Fibrin (PRF) and Retinol

Intervention Type: BIOLOGICAL

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

Interventions

Platelet Rich Fibrin (PRF)

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

Intervention Type: 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)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Abdallah Hassan Mostafa

B.Sc., M.Sc. Abdallah Hassan Mostafa

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdallah H. Mostafa, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Central Contacts

Abdallah H. Mostafa, M.Sc.

Role: CONTACT

dr.abdallah.hassan@gmail.com

+2001005682509

Other Identifiers

121221

Identifier Type: -

Identifier Source: org_study_id