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Outcome Measures

Primary Outcomes (1)

Proteomic biomarker expression changes in wound exudate (NSAF-based analysis)
Wound exudate from the three groups will be analysed to assess for changes in protein expression and signalling pathways during early wound healing. A small sterile medical grade PVA sponge will be used to collect the wound exudate from the extraction socket (such as NETCELL® PVA Microspheres, Network Medical Products Ltd, North Yorkshire, UK). Analytes involved in the healing process such as angiogenesis, wound healing, inflammation, bone remodelling, and formation will be selected based on the pathways identified in the genomic and proteomic work and literature search performed by our group. Multiplex (Luminex, R\&D systems, Minneapolis, MN, USA) immunoassays will be designed specifically for quantitative analyses in the wound exudate of the socket. The molecular (proteomic) changes of wound exudate of the dental extraction socket will be assessed at 1, 3, 7, 15 days after extraction based on the Normalised Spectral Abundance Factor (NSAF) proteomic analysis.
At 1, 3, 7 and 15 days post-extraction

Interventions

Application of A-PRF into extraction socketProcedure

For patients in the A-PRF group, venepuncture will be performed with a tourniquet, a butterfly needle (such as a 21-gauge Vacutainer Safety-Lok), and A-PRF blood bottles. Two 10 mL vials of blood will be obtained. The vials will be centrifuged at 1300 rpm using the Choukroun Duo Quattro PRF Centrifuge for 14 min. For patients on anticoagulant medication, the vials will undergo further centrifugation for 2 minutes. The A-PRF clots are then removed from the tube and separated from the red blood cells and platelet-poor plasma. They are then placed in an expression kit for 10 min (which will be monitored using a timer) to drain and compress. Once the membranes have been compressed for at least 10 minutes, they will be placed in the extraction socket and secured with 4-0 PTFE sutures.

Patients with MRONJ

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Purpose

TREATMENT

Intervention Model

SINGLE GROUP

Model Details: Experimental intervention - A-PRF preparation Venipuncture and collection of blood in 10 ml tubes (2 tubes) Centrifugation (BTI SYSTEM IV® Model Centrifuge) at 1300 rpm with centrifuge machine for 14 min PRF clots are removed from the tube and separated from red blood cells and platelet-poor plasma. They are then placed in an expression kit for 10 min to drain and compress.

Sponsor Type

OTHER

Responsible Party

SPONSOR

Autologous Platelet Concentrates on the Healing of Extraction Sockets

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Patients with MRONJ

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Design

Study Record Dates

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Patients with MRONJ

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Design

Study Record Dates

Source record