Tokyo, Nov. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059615) titled 'Comparative Evaluation of the Effect of UV Photofunctionalization and i-PRF Biofunctionalization on Osseointegration of Dental Implants: A Clinical and Radiographic Study' on Nov. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH
Condition:
Condition - Dental implants have become a reliable solution for restoring missing teeth, with long-term success largely dependent on achieving and maintaining osseointegration. Despite the high success rates reported, implant failures are still observed, commonly due to inadequate osseointegration or peri-implant infections. To improve outcomes, various surface modification strategies have been developed. UV treatment enhances protein adsorption, osteoblast attachment, and bone formation, thereby accelerating and improving osseointegration. On the other hand, biological approaches such as injectable platelet-rich fibrin (i-PRF) provide a biofunctionalization method that delivers autologous growth factors, including platelet-derived growth factor and vascular endothelial growth factor, which promote angiogenesis and osteogenesis.
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate and compare effects of UV photofunctionalization and iPRF biofunctionalization on implant osseointegration using clinical and radiographic parameters.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - UV PHOTOFUNCTIONALISATION TO ENHANCE OSSEOINTEGRATION FOR DENTAL IMPLANT PLACEMENT
Interventions/Control_2 - i-PRF BIOFUNCTIONALISATION TO ENHANCE OSSEOINTEGRATION FOR DENTAL IMPLANT PLACEMENT
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Subjects more than 18 years
2. Able to provide consent
3. Presence of healthy periodontium in adjacent teeth
4. Presence of D2 or D3 quality of bone
5. Minimum 1.5 mm bone must remain between dental implant and neighboring teeth as well as on facial side, and 0.5 mm bone must remain between implant and palatal side
Key exclusion criteria - 1. Systemic diseases or metabolic disorders if any which may impact study, pregnant and lactating women.
2. Current smoker or quitted smoking <1 year ago
3. Parafunctional activities
4. Uncontrolled periodontal disease, caries, or clinical or radiographic signs of infection within two adjacent teeth
5. Current chemotherapy/radiotherapy or drugs that interfere with study.
Target Size - 20
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 07 Month 15 Day
Date of IRB - 2024 Year 08 Month 16 Day
Anticipated trial start date - 2025 Year 11 Month 02 Day
Last follow-up date - 2026 Year 07 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068194
Disclaimer: Curated by HT Syndication.