Effect of Vitamin D3 Supplementation on Serum Sphingosine-1-Phosphate Levels and Dental Implant Osseointegration: A Prospective Study
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
This study aims to evaluate whether vitamin D3 supplementation can promote dental implant osseointegration by increasing serum sphingosine-1-phosphate (S1P) levels. Sixty patients scheduled for dental implant surgery between July 2025 and December 2026 will be enrolled. Before surgery, baseline clinical data, cone-beam computed tomography (CBCT) imaging data, and blood samples for serum S1P measurement by ELISA will be collected. Based on baseline S1P levels, 40 patients with low S1P levels will be selected and randomized into a control group and an intervention group, with the intervention group receiving daily vitamin D3 supplementation (800 IU) from immediately after surgery until 3 months postoperatively. At the 3-month follow-up, CBCT images will be acquired again and compared with baseline to assess osseointegration, implant stability will be evaluated by measuring implant stability quotient (ISQ) values, and serum S1P levels will be re-measured. Statistical analysis will be performed using R software. The primary endpoint is the effect of vitamin D3 supplementation on dental implant osseointegration, while secondary endpoints include changes in serum S1P levels, implant stability (ISQ), and safety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2026
CompletedFirst Posted
Study publicly available on registry
October 20, 2026
CompletedStudy Start
First participant enrolled
October 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
Study Completion
Last participant's last visit for all outcomes
October 1, 2027
October 20, 2026
October 1, 2026
11 months
October 13, 2026
October 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of Vitamin D3 Supplementation on Dental Implant Osseointegration
Assessment of peri-implant bone changes and osseointegration using cone-beam computed tomography (CBCT) at 3 months postoperatively compared with baseline.
Baseline and 3 months postoperatively
Secondary Outcomes (2)
Baseline and 3 months postoperatively
Baseline and 3 months postoperatively
Implant Stability Quotient (ISQ)
3 months postoperatively
Study Arms (3)
High S1P group
NO INTERVENTIONPatients with high baseline S1P levels receiving standard postoperative care without vitamin D3 supplementation.
Low S1P control group
NO INTERVENTIONPatients with low baseline S1P levels receiving standard postoperative care without vitamin D3 supplementation.
Low S1P vitamin D3 intervention group
EXPERIMENTALPatients with low baseline S1P levels receiving daily oral vitamin D3 supplementation (800 IU) for 3 months postoperatively.
Interventions
Oral vitamin D3 supplementation at a dose of 800 IU daily for 3 months postoperatively.
Eligibility Criteria
You may qualify if:
- Patients with a single missing tooth requiring implant restoration.
- Intact lingual or palatal bone wall at the edentulous site, with sufficient bone volume for implant placement confirmed by preoperative CBCT evaluation.
- Healthy opposing and adjacent teeth, with sufficient interocclusal space and normal occlusion and overbite relationships.
- Good treatment compliance. -
You may not qualify if:
- Insufficient mesiodistal width for implant placement.
- Presence of poor oral habits such as heavy smoking (\>10 cigarettes/day), bruxism, or periodontal disease.
- Pregnant or lactating women.
- Poor general health condition, unable to tolerate surgery.
- Patients currently undergoing orthodontic treatment.
- Patients taking medications affecting bone metabolism.
- Allergy to Vitamin D3.
- Any medical condition contraindicated for Vitamin D3 supplementation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
October 13, 2026
First Posted
October 20, 2026
Study Start (Estimated)
October 30, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
October 20, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will not share
The individual participant data (IPD) will not be shared due to privacy and ethical restrictions. The data contain sensitive patient information, and sharing them would compromise participant confidentiality. Additionally, national and institutional regulations restrict the sharing of clinical data with external parties or international databases. De-identified data may be available from the corresponding author upon reasonable request and with approval from the institutional ethics committee.