Clinical trial NCT06147310: Effect Alb-PRF & A-PRF in Alveolar Ridge Preservation in Diabetes Patients - A RCCT
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tooth Extraction Status Nos
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel group, randomized-controlled, single-blinded, superiority clinical study.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Ridge horizontal width
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Ridge height
timeFrame: Up to 20 weeks
measure: Ridge volume and profile
timeFrame: Up to 20 weeks
measure: Keratinized tissue width changes
timeFrame: Up to 20 weeks
measure: Cytokines and growth factors
timeFrame: Up to 56 days
measure: Implant planning related outcome
timeFrame: Up to 20 weeks
measure: Histological assessment
timeFrame: Up to 24 weeks
measure: Patient-reported outcome measures
timeFrame: Up to 28 days
measure: Inflammatory proliferative remodelling
timeFrame: Up to 28 days
Other outcomes:
Locations:
Study officials:
affiliation: The University of Hong Kong
name: Melissa Fok
role: PRINCIPAL_INVESTIGATOR
References: