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

NCT ID: NCT06147310

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Tooth Extraction Status Nos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel group, randomized-controlled, single-blinded, superiority clinical study.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participlant will be masked Care provider and investigator could not be masked due to the intrinsic nature of the intervention, however the allocation will be concealed until the extraction of teeth is completed.

Outcome assessor will be masked

Study Groups

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Study Group

Alveolar ridge preservation with Alb-PRF + A-PRF after extraction

Group Type EXPERIMENTAL

Study Group

Intervention Type PROCEDURE

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.

Control Group

Spontaneous healing after extraction

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Albumin-platelet rich fibrin, Advanced platelet rich fibrin

Eligibility Criteria

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Exclusion Criteria

i. Patients with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability.

ii. Pregnancy or intention to become pregnant at any point during the study duration.

iii. Smoker /alcoholic iv. Has platelet dysfunction/ thrombocytopenia/ blood dyscrasia v. On bisphosphonates or drugs that will significantly alter bone metabolism. vi. ASA III/IV.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Melissa Fok

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melissa Fok

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Central Contacts

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Melissa R Fok

Role: CONTACT

Phone: 2859 0495

Email: [email protected]

Catherine Mok

Role: CONTACT

Phone: 2859 0301

Email: [email protected]

Other Identifiers

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L2023_01

Identifier Type: -

Identifier Source: org_study_id