Evaluation of Modified Minimally Invasive Surgical Technique and Platelet Rich Fibrin With or Without Vitamin Pool A and C for Management of Periodontal Intrabony Defects

NCT05499598 | Completed

• 1 other identifier: PERAUG2022
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess clinical and radiographic outcomes after the use of vitamins A and C with PRF versus PRF alone in the treatment of periodontal intrabony defect.

Conditions

Intrabony Periodontal Defect

Outcome Measures

Primary Outcomes (1)

• Radiographic linear defect depth (mm)

  Digital Radiographs using ImageJ software, Measured as the depth of intra-osseous defect from the alveolar crest to the defect.

  9 months

Secondary Outcomes (3)

• Probing depth (mm)

  9 months

• Clinical Attachment Level (mm)

  9 months

• Gingival Recession Depth (mm)

  9 months

Study Arms (2)

Modified minimally invasive surgical technique with PRF and vitamins A and C

EXPERIMENTAL

Surgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. Ascorbic Acid will be added to the fresh blood to achieve a concentration of 250 μg/ml, Retinol will also be added to achieve a concentration of 20 μmol/L. The resultant PRF clot will be placed into the intra-osseous defect.

Procedure: Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and C

Modified minimally invasive surgical technique with PRF

ACTIVE COMPARATOR

Surgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of whole blood is drawn by venipuncture of the antecubital vein and is collected into two blood collection tubes without anticoagulant for PRF preparation.The resultant PRF clot will be placed into the intra-osseous defect

Procedure: Modified minimally invasive surgical technique with PRF

Interventions

Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and C PROCEDURE

Surgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. Ascorbic Acid will be added to the fresh blood to achieve a concentration of 250 μg/ml, Retinol will also be added to achieve a concentration of 20 μmol/L. The resultant PRF clot will be placed into the intra-osseous defect.

Modified minimally invasive surgical technique with PRF and vitamins A and C

Modified minimally invasive surgical technique with PRF PROCEDURE

Surgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. The resultant PRF clot will be placed into the intra-osseous defect.

Modified minimally invasive surgical technique with PRF

Eligibility Criteria

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

You may qualify if:

• Patient-related criteria:
• Patient consulting in the outpatient clinic with periodontitis stage III
• Able to tolerate surgical periodontal procedures.
• Patient ready to perform oral hygiene instructions.
• Compliance with the maintenance program.
• Provide informed consent.
• Accepts the 6 months follow-up period.
• Teeth related criteria:
• Mature permanent tooth.
• Tooth with two or three-walled intra-bony defect, with CAL ≥ 5mm and intra osseous defect ≥ 3mm.

You may not qualify if:

• Patient-related criteria:
• Medically compromised patients.
• Pregnant or nursing women.
• Uncooperative patients.
• Smokers.
• Teeth related criteria:
• Teeth with one wall intra-bony defect.
• Teeth with supra-bony defects.
• Teeth with grade III mobility.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (4)

• Heitz-Mayfield LJ, Lang NP. Surgical and nonsurgical periodontal therapy. Learned and unlearned concepts. Periodontol 2000. 2013 Jun;62(1):218-31. doi: 10.1111/prd.12008.

  PMID: 23574468 BACKGROUND

• Elbehwashy MT, Hosny MM, Elfana A, Nawar A, Fawzy El-Sayed K. Clinical and radiographic effects of ascorbic acid-augmented platelet-rich fibrin versus platelet-rich fibrin alone in intra-osseous defects of stage-III periodontitis patients: a randomized controlled clinical trial. Clin Oral Investig. 2021 Nov;25(11):6309-6319. doi: 10.1007/s00784-021-03929-1. Epub 2021 Apr 12.

  PMID: 33842996 BACKGROUND

• Fawzy El-Sayed KM, Hein D, Dorfer CE. Retinol/inflammation affect stemness and differentiation potential of gingival stem/progenitor cells via Wnt/beta-catenin. J Periodontal Res. 2019 Aug;54(4):413-423. doi: 10.1111/jre.12643. Epub 2019 Mar 4.

  PMID: 30830694 BACKGROUND

• Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.

  PMID: 16504849 BACKGROUND

MeSH Terms

Interventions

Prolactin-Releasing Hormone

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 12, 2022
• Study Start: September 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: May 30, 2024
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

EG (1)