NCT06147310

Effect Alb-PRF & A-PRF in Alveolar Ridge Preservation in Diabetes Patients - A RCCT

Effect of Albumin Gel-platelet-rich Fibrin (Alb-PRF) and Advanced Platelet-rich Fibrin (A-PRF) in Alveolar Ridge Preservation in Diabetes Patients - A Randomized Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aim to investigate the effect of albumin gel- and platelet- rich fibrin(Alb-PRF) combined with advanced platelet-rich fibrin (A-PRF) on alveolar ridge preservation by comparing alveolar ridge morphometric changes (hard and soft tissue), prospects and treatment complexity for placement of prosthetically guided dental implant, early oral wound healing outcomes evaluated by the Inflammatory Proliferative Remodeling Scale, and patient reported outcome measures, in Type I/II Diabetes Mellitus patient, versus spontaneous healing

Detailed description

Diabetes is a well-established risk factor for oral diseases that often lead to extractions and tooth loss in the population, while diabetic patients also have increased susceptibility to wound infections. Albumin gel-platelet-rich fibrin (Alb-PRF) and advanced platelet-rich fibrin (A-PRF) are third-generation of platelet concentrates derived from a donor's blood by following a simple centrifugation protocol, heat treatment of platelet-poor plasma, and mixing of liquid-PRF from the same preparation. This study proposes a novel alveolar ridge preservation technique based on the application of A-PRF inside the extraction socket to sustain the release of growth factors during the early wound healing phase, together with periosteum inhibition by overlaying an Alb-PRF membrane with slow biodegradation and space maintenance properties over the bone to reduce post-extraction alveolar ridge resorption.

Conditions

• Tooth Extraction Status Nos

Interventions

Type	Name	Description
PROCEDURE	Study Group	The tooth will be extracted automatically, tooth sectioning will be performed if necessary for multi-rooted teeth to minimize trauma. Alveolar ridge preservation with blood platelet concentrate: heat-treated albumin (Alb-PRF) and advanced platelet-rich fibrin. The experimental site will be filled with A-PRF plugs/membranes until level flushed with the level of bone. An additional Alb-PRF membrane will be tucked and inserted below the buccal and oral flap. Surgical flaps will not be raised. Soft tissue will be tunnelled and undermined for insertion of the Alb-PRF membrane. The extraction site and membranes will be stabilized by cross-mattress sutures and allowed for secondary intention healing.
PROCEDURE	Control Group	The tooth will be extracted automatically, tooth sectioning will be performed if necessary for multi-rooted teeth to minimize trauma. Cross mattress suture will be applied and site allowed to heal naturally.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-03-31
• Completion: 2026-06-30
• First posted: 2023-11-27
• Last updated: 2023-11-29