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

NCT06147310 | Not Yet Recruiting

• 1 other identifier: L2023_01
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Tooth Extraction Status Nos

Outcome Measures

Primary Outcomes (1)

• Ridge horizontal width

  Ridge horizontal width changes (1mm, 3mm, 5mm apical to most coronal crest at buccal/oral) Method: CBCT

  Up to 20 weeks

Secondary Outcomes (8)

• Ridge height

  Up to 20 weeks

• Ridge volume and profile

  Up to 20 weeks

• Keratinized tissue width changes

  Up to 20 weeks

• Cytokines and growth factors

  Up to 56 days

• Implant planning related outcome

  Up to 20 weeks

Study Arms (2)

Study Group

EXPERIMENTAL

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

Procedure: Study Group

Control Group

PLACEBO COMPARATOR

Spontaneous healing after extraction

Procedure: Control Group

Interventions

Study Group 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.

Also known as: Albumin-platelet rich fibrin, Advanced platelet rich fibrin

Study Group

Control Group 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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Melissa Fok

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa R Fok

CONTACT

2859 0495; melfok@hku.hk

Catherine Mok

CONTACT

2859 0301; cathmok@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Prospective, parallel group, randomized-controlled, single-blinded, superiority clinical study.

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 27, 2023
• Study Start: September 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share