Tokyo, Nov. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059637) titled 'Radiological and histological analysis of alveolar ridge preservation using octacalcium phosphate collagen composite(OCP/Col)' on Nov. 5.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Tohoku University
Condition:
Condition - missing tooth
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate the bone regeneration capability of Octacalcium Phosphate Collagen Composites (OCP/Col) when used alone for ridge preservation procedures (ARP), from radiographic and histological perspectives.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - In patients scheduled for ridge preservation (ARP) at the time of extraction with implant therapy planned, the molar group(OCP-M group) using Octacalcium Phosphate Collagen (OCP/Col) was designated (OCP-M group).
Interventions/Control_2 - In patients scheduled for ridge preservation (ARP) at the time of extraction with implant therapy planned, the anterior teeth and premolar group (OCP-IP group) using Octacalcium Phosphate Collagen (OCP/Col) was designated.
Eligibility:
Age-lower limit - 18
years-old
7)
Patients currently using or with a history of bisphosphonate preparations or denosumab
Patients with neurocognitive disorders
Smokers
Patients on steroids
Patients using immunosuppressants
Patients with liver dysfunction or kidney dysfunction
Patients undergoing chemotherapy or radiotherapy, or with a history of head and neck radiotherapy
Pregnant or breastfeeding women
Patients who did not wish to participate in this study
Patients who withdrew consent to participate
Patients in whom histological examination could not be performed due to anatomical requirements, etc.
Patients with alveolar bone damage caused by tooth extraction procedures
Patients in whom the specimen for bone biopsy was damaged or its orientation was unclear, making analysis impossible
Target Size - 48
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2023 Year 07 Month 26 Day
Date of IRB - 2023 Year 07 Month 26 Day
Anticipated trial start date - 2023 Year 07 Month 26 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068214
Disclaimer: Curated by HT Syndication.