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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- The University of Hong Kong
- Enrollment
- 74
- Primary Endpoint
- Ridge horizontal width
Study Overview
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •i. At least 18 years old with established TIIDM diagnosis for more than 0.5 years, fasting blood glucose ≥7.0 mmol/L or 2 h plasma glucose ≥11.1 mmol/L, maximum HbA1c levels under 8.0%.
- •ii. Non-smoker, diagnosed with generalized periodontitis stage III or IV. iii. Need for extraction of teeth, on opposing arches or opposing sides, with or without other concurrent indications for extractions: orthodontics, periodontitis, caries, fracture, root resorption, unrestorable root fragments.
- •iv. At least one adjacent teeth/ implant is present at the site of extraction with a secure prognosis.
- •v. No periapical lesions with a diameter of more than 5 mm (radiographically determined.
- •vi. Extraction socket with a bone height of at least 7mm at 2 walls. vii. Reasonably aligned dental arches viii. Will consider implant to replace missing teeth ix. Willing and able to give informed consent.
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.
Arms & Interventions
Study Group
Alveolar ridge preservation with Alb-PRF + A-PRF after extraction
Intervention: Study Group (Procedure)
Control Group
Spontaneous healing after extraction
Intervention: Control Group (Procedure)
Outcomes
Primary Outcomes
Ridge horizontal width
Time Frame: Up to 20 weeks
Ridge horizontal width changes (1mm, 3mm, 5mm apical to most coronal crest at buccal/oral) Method: CBCT
Secondary Outcomes
- Cytokines and growth factors(Up to 56 days)
- Implant planning related outcome(Up to 20 weeks)
- Histological assessment(Up to 24 weeks)
- Keratinized tissue width changes(Up to 20 weeks)
- Patient-reported outcome measures(Up to 28 days)
- Ridge volume and profile(Up to 20 weeks)
- Ridge height(Up to 20 weeks)
- Inflammatory proliferative remodelling(Up to 28 days)
Investigators
Dr. Melissa Fok
Clinical Assistant Professor
The University of Hong Kong