Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration

Not yet recruiting

• Conditions: Implant Site Reaction

• Registration Number: NCT06776640
• Lead Sponsor: Nantes University Hospital

Brief Summary

The number of patients treated in Implantology at Nantes University Hospital is 400 per year. This pilot study aims to demonstrate the efficacy of a 6-month oral cholecalciferol supplementation on osseointegration in patients requiring dental implants and presenting with vitamin D deficiency, compared to French patients who have not undergone vitamin D screening

Detailed Description

This study will be conducted on patients with vitamin D deficiency or insufficiency who visit the Restorative and Surgical Dentistry Department at the Dental Care Center of Nantes University Hospital for implant surgery. The investigator will present the study to them and record their verbal non-opposition. Clinical data from before the surgery (approximately 3 months prior), during the surgery, and postoperative visits up to 3 months afterward will be included in the OSIVID study.

Study Timeline

• Study First Submitted: 2024-12-20
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study Start: 2025-01-15
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2027-01-15
• Study Completion: 2027-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male or female patient ≥ 18 years old, candidate for dental implant placement.
• with vitamin D deficiency or insufficiency: 25(OH)D < 25 ng/L.
• affiliated with a social security scheme.

Exclusion Criteria

• with a local contraindication for implant placement.
• under guardianship, curatorship, or legal protection
• Pregnant or breastfeeding women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The stability of the implan	3 months (surgery and 3 months after)	The stability of the implant measured by RFA (Resonance Frequency Analysis)