UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062985 |
|---|---|
| Receipt number | R000072111 |
| Scientific Title | Impact of Oral Vitamin D3 supplementation on changes in bone level at implant site during the process of osseointegration: a randomized controlled trial |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/18 19:32:37 |
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Basic information
Public title
Impact of Oral Vitamin D3 supplementation on changes in bone level at implant site during the process of osseointegration
Acronym
VIT-D IMPLANT Trial
Scientific Title
Impact of Oral Vitamin D3 supplementation on changes in bone level at implant site during the process of osseointegration: a randomized controlled trial
Scientific Title:Acronym
VITAMIN-D3 OSSEO Trial
Region
| Asia(except Japan) |
Condition
Condition
Peri-implant bone healing following dental implant placement
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in peri-implant marginal bone level from baseline to 12 and 16 weeks after implant placement, assessed using standardized intraoral periapical radiographs (RVG) and CBCT.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
No Vitamin D3 supplementation
Interventions/Control_2
Vitamin D3 60,000 IU orally once weekly for 6 weeks
Interventions/Control_3
Vitamin D3 60,000 IU orally once weekly for 8 weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | 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 sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Pratyush |
| Middle name | |
| Last name | Mishra |
Organization
Institute of Dental Science, Siksha 'O' Anusandhan (Deemed to be University)
Division name
Department of Prosthodontics, Crown, Bridge and Implantology
Zip code
751003
Address
Bhubaneswar, Odisha
TEL
9078673213
pratyushmishra2@gmail.com
Public contact
Name of contact person
| 1st name | Pratyush |
| Middle name | |
| Last name | Mishra |
Organization
Institute of Dental Science, Siksha 'O' Anusandhan (Deemed to be University)
Division name
Department of Prosthodontics, Crown, Bridge and Implantology
Zip code
751003
Address
Bhubaneswar, Odisha
TEL
7978788756
Homepage URL
pratyushmishra2@gmail.com
Sponsor or person
Institute
Institute of Dental Science, Siksha 'O' Anusandhan (Deemed to be University)
Institute
Department
Personal name
Funding Source
Organization
Institute of Dental Science, Siksha 'O' Anusandhan (Deemed to be University)
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
India
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Dental Science, Siksha 'O' Anusandhan (Deemed to be University)
Address
Institute of Dental Sciences, Siksha O Anusandhan (Deemed to be University), Kalinga Nagar, Ghatikia, Bhubaneswar, Odisha
Tel
06742386908
iec.ids.@soa.ac.in
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 18 | Day |
Last modified on
| 2026 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072111
