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

Study Overview
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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.

Official Title
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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

Conditions
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Tooth Extraction Status Nos

Intervention / Treatment
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* Procedure: Study Group
* Procedure: Control Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, parallel group, randomized-controlled, single-blinded, superiority clinical study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Alveolar ridge preservation with Alb-PRF + A-PRF after extraction | Procedure: Study Group<br>* 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.<br>* Other names: Albumin-platelet rich fibrin, Advanced platelet rich fibrin;|
| Placebo Comparator: Control Group<br>Spontaneous healing after extraction | Procedure: Control Group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ridge height | Ridge height changes (buccal and oral) Method: CBCT | Up to 20 weeks | 
| Ridge volume and profile | Changes in ridge volume and profilometric changes Method: Intraoral scan, CBCT | Up to 20 weeks | 
| Keratinized tissue width changes | Changes in keratinized tissue width Method: Periodontal probe with fixed landmarks | Up to 20 weeks | 
| Cytokines and growth factors | Changes in concentrations of cytokines and growth factors in wound fluid during early to mid-term wound healing events | Up to 56 days | 
| Implant planning related outcome | Ability to place prosthetically guided implant, need for additional augmentation | Up to 20 weeks | 
| Histological assessment | 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 | Up to 24 weeks | 
| Patient-reported outcome measures | 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) | Up to 28 days | 
| Inflammatory proliferative remodelling | IPR score will be assessed by independent assessors with photos of wound site at different itme points | Up to 28 days |