Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062985) titled 'Impact of Oral Vitamin D3 supplementation on changes in bone level at implant site during the process of osseointegration' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Institute of Dental Science, Siksha 'O' Anusandhan (Deemed to be University)
Condition:
Condition - Peri-implant bone healing following dental implant placement
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To analyse the effect of oral Vitamin D3 supplementation on changes in the bone level at the implant site during the process of osseointegration.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - No Vitamin D3 supplementation
Interventions/Control_2 - Vitamin D3 60,000 IU orally once weekly for 6 weeks
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Healthy adults, with no known allergy to dental materials or drugs,
Adults not taking any regular medications
Adults who did not take any vitamin or mineral supplements since last 6 months.
Adults with more than 30ng/ml of 25-hydroxycholecalciferol in blood serum.
Key exclusion criteria - Individuals with inappropriate bone conditions (necessity to perform augmentation procedures)
Individuals with systemic diseases like Diabetes Mellitus, hypertension, Hypo or hyperthyroidism, Rheumatoid Arthritis, Chronic kidney diseases
Individuals under 18 years of age
Individuals with habits of smoking and tobacco use
Individuals with periodontitis.
Individuals with less than 30ng/ml of Vitamin D3.
Target Size - 60
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 09 Month 07 Day
Date of IRB - 2024 Year 09 Month 07 Day
Anticipated trial start date - 2024 Year 10 Month 01 Day
Last follow-up date - 2026 Year 06 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072111
Disclaimer: Curated by HT Syndication.
