Effect Alb-PRF & A-PRF in Alveolar Ridge Preservation in Diabetes Patients - A RCCT
- Conditions
- Tooth Extraction Status Nos
- Interventions
- Procedure: Study GroupProcedure: Control Group
- Registration Number
- NCT06147310
- Lead Sponsor
- The University of Hong Kong
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 74
Not provided
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Group Study Group Alveolar ridge preservation with Alb-PRF + A-PRF after extraction Control Group Control Group Spontaneous healing after extraction
- Primary Outcome Measures
Name Time Method Ridge horizontal width Up to 20 weeks Ridge horizontal width changes (1mm, 3mm, 5mm apical to most coronal crest at buccal/oral) Method: CBCT
- Secondary Outcome Measures
Name Time Method Cytokines and growth factors Up to 56 days Changes in concentrations of cytokines and growth factors in wound fluid during early to mid-term wound healing events
Implant planning related outcome Up to 20 weeks Ability to place prosthetically guided implant, need for additional augmentation
Histological assessment Up to 24 weeks Bone volume to total tissue volume ratio and bone microstructure Method: Core biopsy with trephine at day of implant placement, micro CT and histomorphometric assessment
Keratinized tissue width changes Up to 20 weeks Changes in keratinized tissue width Method: Periodontal probe with fixed landmarks
Patient-reported outcome measures Up to 28 days Patient will be asked to record their pre-operative anxiety level, intraoperative pain level and pain levels at follow up visits on a visual analogue scale (0-10)
Ridge volume and profile Up to 20 weeks Changes in ridge volume and profilometric changes Method: Intraoral scan, CBCT
Ridge height Up to 20 weeks Ridge height changes (buccal and oral) Method: CBCT
Inflammatory proliferative remodelling Up to 28 days IPR score will be assessed by independent assessors with photos of wound site at different itme points