Tokyo, March 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060992) titled 'Morphological, radiological, and histological comparison of alveolar ridge preservation using two types of bone substitute' on March 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Nagasaki University
Condition:
Condition - molar tooth loss
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Alveolar ridge preservation (ARP) is performed to prevent alveolar ridge resorption following the extraction of molars. Two types of bone grafting materials are used for ARP, and their efficacy is compared and evaluated morphologically, radiographically, and histologically.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - hydroxyapatite/collagen composite material
Interventions/Control_2 - octacalcium/collagen composite material
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - Patients aged 20 years or olde but under 90 years at the time of consent acquisition
Patients seeking implant treatment in the molar region
Patients who require tooth extraction at the relevant site and need ARP to prevent bone resorption
The difference in alveolar bone height between buccal and lingual or palatal sides is within 5 mm
Patients who have provided written consent to participate in the study
Key exclusion criteria - Patients with acute inflammation at the treatment site
Smokers (10 or more cigarettes per day)
Pregnant patient
Patients with a history of allergy to collagen
Patients with uncontrolled metabolic disorders (diabetes, osteomalacia, thyroid disease, severe liver or kidney disease)
Patients who are taking long term steroid or immunosuppressive drugs for autoimmune diseases, etc
Patients taking antiresorptive agents
Patients undergoing radiation therapy
Other patients who are not adequate to participate this study
Target Size - 24
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 02 Month 10 Day
Date of IRB - 2026 Year 03 Month 16 Day
Anticipated trial start date - 2026 Year 03 Month 19 Day
Last follow-up date - 2029 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069793
Disclaimer: Curated by HT Syndication.