Treatment of Periodontal Intrabony Defects With Liquid Platelet-Rich Fibrin Mixed With Denaturated Albumin Gel (ALB_PRF)

NCT06798116 | Enrolling By Invitation

• 1 other identifier: A04011023OM
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of study also is to assess radiographic linear defect depth, and radiographic defect bone density following the application of liquid Platelet-Rich Fibrin (PRF) mixed with denaturated Albumin gel (ALB-PRF) or with bone allograft in periodontal intrabony defects. Patients and methods: 28 patients will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University according to Pre-operative CBCT that will be used to evaluate the bone destruction pattern. According to the techniques that used in the treatment of periodontal bony defect, the participants will be randomly divided into 4 equal groups: Group I: will include 7 patients, in which the intrabony periodontal defects will be treated with open flap debridement and demineralized freeze-dried bone allograft (DFDBA) and mixed with liquid (PRF). Group II: will include 7 patients, in which participants will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects. Group III: will include 7 patients, in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane. Group IV: will include 7 patients in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane.

Conditions

Periodontal Bone Loss; Periodontitis Stage III; Intra-bony Pockets

Keywords

ALB-PRF; intrabony defect; periodontitis

Outcome Measures

Primary Outcomes (4)

• pocket depth

  pocket depth: by placing dental probe between your teeth and gumline. Pockets are measured at several places in your upper and lower gums. In a healthy mouth, the pocket depth is usually between 1 and 3 millimetres (mm). Pockets deeper than 4 mm may indicate periodontitis

  pocket depth will be assessed at baseline, 3 and 6 months.

• Plaque index

  Evaluation of existence plaque in all around tooth aspects

  At baseline ,3and 6 months

• Bleeding on Probing

  Evaluation of existence Bleeding during gentle periodontal probing.

  At baseline ,3 and 6months.

• Clinical Attachment Level

  To assess the clinical attachment level.

  At baseline ,3 and 6 months.

Secondary Outcomes (4)

• Pain score

  At day 0,3,5 and 7 post-operatively. While healing will be assess at days 2,7 and 14

• Alveolar ridge width (buccolingual).

  At base line and 6 months starting from base line.

• Alveolar ridge height (apicocronal)

  At base line and 6 months starting from base line.

• Bone density

  At base line and 6 months starting from base line.

Study Arms (4)

open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF)

EXPERIMENTAL

will include 7 patients, in which the intrabony periodontal defects will be treated with open flap debridement and demineralized freeze-dried bone allograft (DFDBA) and mixed with liquid (PRF).

Procedure: Experimental: open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF

liquid (PRF) mixed with denatured albumin gel (ALB-PRF) injected in periodontal intrabony defects

EXPERIMENTAL

will include 7 patients, in which participants will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects.

Procedure: defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects

open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane.

ACTIVE COMPARATOR

will include 7 patients, in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane.

Procedure: defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membrane

open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane.

EXPERIMENTAL

will include 7 patients in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane.

Procedure: open flap debridement , DFDBA mixed with liquid (PRF) and ALB-PRF membrane.

Interventions

Experimental: open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF PROCEDURE

Drawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min. The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form. in this group;, the defects will be treated with open flap debridement and DFDBA and mixed with liquid (PRF)

open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF)

defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects PROCEDURE

Drawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min. The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form. in this group;, defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects.

liquid (PRF) mixed with denatured albumin gel (ALB-PRF) injected in periodontal intrabony defects

defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membrane PROCEDURE

Drawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min. The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form. in this group;, the defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membrane

open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane.

open flap debridement , DFDBA mixed with liquid (PRF) and ALB-PRF membrane. PROCEDURE

Drawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min. The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form. in this group;, the defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and ALB-PRF membrane.

open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane.

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Periodontist stage III according to classification of periodontal and peri-implant disease and conditions (2018).
• Patient with two or three walls or combined bony defect.
• Favourable pattern of occlusion.
• Patient ability to comply with the required recall visits.

You may not qualify if:

• Local or systemic diseases that contraindicate surgery.
• Smokers
• Patients with parafunctional habits.
• Pregnancy or lactation.
• Diabetic patient.
• Osteoporosis.
• Immune-suppressed condition that may affect the outcome of the therapy.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

faculty of dentistry Mansoura university

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss; Periodontitis

Interventions

Fluid Therapy; Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Dhaidan Naif Alshammari, Bachelor

  faculty of dentistry Mansoura university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: surgery and give medication

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: January 29, 2025
• Study Start: January 3, 2024
• Primary Completion: January 24, 2025
• Study Completion: February 2, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)