Status:
NOT_YET_RECRUITING
Effect Alb-PRF & A-PRF in Alveolar Ridge Preservation in Diabetes Patients - A RCCT
Lead Sponsor:
The University of Hong Kong
Conditions:
Tooth Extraction Status Nos
Eligibility:
All Genders
18+ years
Phase:
NA
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 rid...
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 infect...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06147310
Start Date
September 1 2024
End Date
June 30 2026
Last Update
November 29 2023
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