Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration (OSIVID)

Efficacy of Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration in Patients With Vitamin D Deficiency

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

Study Overview

• Status: Not yet recruiting
• Conditions: Implant Site Reaction

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Alexandra Poinas, PhD; Phone Number: 0253482857; Email: alexandra.poinas@chu-nantes.fr
• Study Contact Backup: Name: Anne-Gaelle Chaux, MD PhD; Phone Number: 02 53 48 28 35; Email: annegaelle.chaux@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patient with supplementation of vitamin D3; perioperative oral vitamin D3 supplementation on implant osseointegration in patients with vitamin D deficiency.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The stability of the implan	The stability of the implant measured by RFA (Resonance Frequency Analysis)	3 months (surgery and 3 months after)

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Anne-Gaelle Chaux, MD PhD, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): May 15, 2027

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: AP_AGC_osivid_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No