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

NCT05285293 | Unknown

• 1 other identifier: 121221
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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?

Conditions

Intrabony Periodontal Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical attachment level

  6 Month

• Probing pocket depth

  6 Month

• Radiographic defect bone density

  6 MOnth

Study Arms (2)

Group 1 Control

ACTIVE COMPARATOR

PRF in intra-bony defects

Biological: Platelet Rich Fibrin (PRF)

Group 2 Experimental

EXPERIMENTAL

PRF and Retinol in intra-bony defects

Biological: Platelet Rich Fibrin (PRF) and Retinol

Interventions

Platelet Rich Fibrin (PRF) BIOLOGICAL

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

Group 1 Control

Platelet Rich Fibrin (PRF) and Retinol BIOLOGICAL

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

Group 2 Experimental

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Prolactin-Releasing Hormone; Vitamin A

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Abdallah H. Mostafa, M.Sc

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdallah H. Mostafa, M.Sc.

CONTACT

+2001005682509; dr.abdallah.hassan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.Sc., M.Sc. Abdallah Hassan Mostafa

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 17, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available once the study is over and for one year
• Access Criteria: by emailing " Dr.abdallah.hassan@gmail.com"

Locations

EG (1)