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

Launched by THE UNIVERSITY OF HONG KONG · Nov 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how two specific treatments, called albumin gel- and platelet-rich fibrin (Alb-PRF) and advanced platelet-rich fibrin (A-PRF), can help preserve the bone and soft tissue in the mouth after a tooth extraction in patients with diabetes. The goal is to see if these treatments improve healing and make it easier to place dental implants later on compared to letting the area heal on its own. The study will look at changes in the bone and tissue, how patients feel about their healing, and other factors related to the treatment.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with Type I or Type II diabetes for at least six months. You should also be a non-smoker and have a specific dental condition that requires tooth extraction. Additionally, you must be willing to give informed consent and meet certain health criteria. If you join the study, you can expect to receive one of the two treatments and be monitored over time to evaluate how well you heal and any other relevant outcomes. This trial is not yet recruiting participants, so further details will be provided when the study begins.

Gender

ALL

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.